Currently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the ‘Patient Enablement Instrument’, we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test–retest reliability, measurement error, responsiveness and floor and ceiling effects.The PEI-BP consists of 6 items that are rated on a 0–10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test–retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance , mental health (SF-36), educational level and number of previous episodes of low back pain.The PEI-BP was found to have acceptable content validity, construct validity, reliability  and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population.The PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended.Trial registration: Not applicable.The online version contains supplementary material available at 10.1186/s12955-021-01758-0. Most people experience low back pain (LBP) some time in their life , and mosIn 1997 Howie et al. presented the concept of enablement representing patients’ empowerment and ability to understand and cope with their health and illness. In order to measure enablement, they developed the ‘Patient Enablement Instrument’ (PEI) based on the theory that other important outcomes will improve if the patients experience increased enablement after a consultation in primary care –8. The PInspired by the PEI, researchers from Denmark and Sweden created the Patient Enablement Instrument for Back Pain (PEI-BP) which could potentially be used as an outcome measure for interventions aiming to improve self-management in people who seek care for LBP. However, before using the instrument as an outcome measure in research settings or in clinical practice, further investigation of the clinimetric properties of the instrument are needed.Therefore, the aim of this project was to investigate the validity, reliability and responsiveness of the Patient Enablement Instrument for Back Pain. The specific objectives were to describe the development of the PEI-BP and investigate content validity, construct validity, internal consistency, test–retest reliability, measurement error, responsiveness and floor and ceiling effects when applied to patients with non-specific LBP who consult either chiropractors or physiotherapists in Denmark.The PEI-BP was adapted from the original PEI , 7, 8 wiwww.spoergeskemaer.dk/pei-bp.The PEI-BP consists of 6 items measured on a 0–10 numeric rating scale  with a total maximum score of 60, with high scores indicating higher enablement. To make the PEI-BP available to international researchers, an English translation and cross-cultural adaptation of the PEI-BP was conducted by two independent native-English speaking persons with non-clinical backgrounds. The final translation committee also included two health professionals with one of these being an expert in the methodology. There were minor differences when comparing the translations of the PEI-BP from Danish to English, however, the translation committee reached consensus after discussions on the content of the questions. The Danish PEI-BP was used in this project and is available in Additional file Measurement properties for the PEI-BP were evaluated based on three cohorts: The content validity cohort, the GLA:D® Back cohort and the test–retest cohort. Reporting will follow Guidelines for Reporting Reliability and Agreement Studies (GRASS) by Kottner et al.  and willFrom March and until May 2017, selected physiotherapy and chiropractic clinics with group-based back training were contacted by two student assistants from the University of Southern Denmark. Volunteering clinics were asked to identify five patients with back pain who were willing to participate in a semi-structured interview. The patients should participate in supervised training , be at least 18 years of age and have had back pain for at least 4 weeks before the first appointment in the clinic. Consenting participants received the PEI-BP questionnaire at the clinic and were asked to complete it the same day. The clinics sent contact details from the consenting participants to the student assistants who also completed the interviews.The GLA:D® Back cohort was established to test the feasibility of implementing the GLA:D® Back programme in primary care chiropractic and physiotherapy clinics in Denmark . Four chA target sample size of at least 200 participants was planned for this cohort which was estimated to ensure a stable variance–covariance matrix in an exploratory factor analysis. A sample size of 4–10 participants per item and more than 100 subjects has been suggested as sufficient .® Back Cohort. Participants were recruited from two primary care physiotherapy and three chiropractic clinics in the region of Southern Denmark between September and November 2018. Inclusion criteria were established to recruit a comparable cohort based on the characteristics of the GLA:D® Back cohort: (1) at least 18 years of age, (2) LBP had impacted activities of daily living for more than 1 month, (3) at least 3 consultations for treatment within the past 2 years, (4) no pain below the knee and (5) could speak and understand Danish.The test–retest cohort was established specifically for this study by two student assistants at the University of Southern Denmark as data for analysing test–retest was not available from the GLA:D® Back Cohort was low, we deemed that including patients with ‘no pain below the knee’ was the best way of getting a comparable cohort.As the overall leg pain intensity of the GLA:DFor a valid test of reliability, at least 50 participants were expected to complete both questionnaires and with no change in back pain intensity between the two time points . The stuIn the content validity cohort semi-structured telephone interviews were conducted and audio recorded. The interviews included two main topics: (1) comprehensibility of each item of the questionnaire, and (2) the overall relevance of the questionnaire and response options. For each item, the respondents were asked about their interpretation of the item. Responses were compared to pre-defined response themes including “I don’t know” and responses unrelated to these options were noted. The themes covered the types of responses that had been considered most likely for each item beforehand. The participants were also encouraged to add any comments they found relevant during the interview. Recruitment continued until the same responses were obtained, and during four subsequent interviews no new themes emerged.In the GLA:D® Back and the test–retest cohorts, participants completed self-reported questionnaires which covered demographics, patient back pain history and core outcome domains for the evaluation of back pain in clinical trials according to the consensus statement by Chiarotto et al.  and back pain beliefs (BIPQ) [r = −0.54]). One hypothesis comparing ‘understanding your back pain / back problem’ (Table The PEI-BP was responsive when compared to commonly used instruments for patients with LBP  r = −0.6 and bacThe results of our hypothesis testing showed a high correlation between a low disability (ODI) score and a high enablement (PEI-BP) score, and as the average baseline ODI score was quite low in our population, this might explain part of the high PEI-BP score at baseline. The potential ceiling effect should be addressed in further development of the PEI-BP. From the item analysis, item 6 (manage your life independently) and item 1 (handle your everyday life) particularly seem to add to this effect. The original PEI was not developed to measure change over time and the scale range was smaller, however, Remelhe et al. did also identify a tendency for ceiling effects when using the original scale (0–2) . BecauseThe relatively large number of participants is a strength in the context of the planned statistical analysis, although the number of included participants in the test–retest cohort preferable should have been higher and therefore, the results based on those data should be interpreted with caution.The use of 2 cohorts for different analysis is also a potential weakness, however the analyses revealed no statistical baseline differences between the two cohorts.The majority of participants were females, which might reduce the generalisability of the study , 50–52, Based on the Patient Enablement Instrument, we developed the Patient Enablement Instrument for Back Pain, PEI-BP. The PEI-BP has acceptable content validity, construct validity, reliability  and responsiveness. Thus, the PEI-BP can be considered a valid and reliable tool to measure enablement in people seeking care for non-specific LBP in research settings. Further testing of the PEI-BP in populations with more severe LBP is recommended.Additional file 1: A Danish, English and Swedish version of the Patient Enablement Instrument for Back Pain questionnaire (PEI-BP).Additional file 2: A figure showing the change scores from baseline to 4 months of the six individual items of the Patient Enablement Instrument for Back Pain.


The present study aimed to determine the pain perceived during supraperiosteal (infiltration) injection in anterior maxillary region by Transcodent painless needle tips in comparison to the regular needle tips.t‐test. A 5% significance level was considered for statically significant difference between two means.In this split‐mouth controlled randomised clinical trial, 30 patients were selected as candidates for cosmetic treatment who needed infiltration injections on both sides of canine area. They were each administered 0.9 mL of Lidocaine HCl 2% with epinephrine 1:100,000 in the buccal vestibules using two types of needle tips, Transcodent painless needle tip or regular needle tip. Immediately after the injection, the pain was measured using a 100 mm visual analog scale. The level of pain was statistically analyzed in the two groups using the parametric paired p < 0.05).In accordance with the results, the patients' level of pain were estimated as 18.3 ± 10.7 mm with Transcodent painless needle tips and 43.1 ± 13.1 mm in regular needle tip (The Transcodent painless needle showed considerable reduction of pain in the anterior maxillary infiltration when compared to the regular needle tips. It is usually associated with a scare of needles, drills, pain, or other settings of dental practices. In addition to delaying and even avoiding dental treatment, dental anxiety may cause unexpected behaviors of patients that prevents the dentist from carrying out routine dental procedures. Anxiety in the patients and its repeated experience during dental visits also affect the dentists' efficiency and self‐confidence. Since providing effective dental services is instrumental in determining the health index of the society, anxiety in patients and their reluctance to receiving dental health services have a negative impact on the health index of the society  tips in comparison to the regular needle tips.2α = 0.05 and test power of 80%, the projected sample size needed with the estimated effect size was approximately 22 cases. To escalate the power of the study it was increased to 30 cases.A statistical power analysis was performed for sample size estimation, based on effect size of a pilot study. With In the present research, a split‐mouth and randomized triple‐blind clinical trial was carried out among 30 patients who were candidates for cosmetic treatments in the Restorative Department of the university and volunteer to participate in the research and signed the Informed Consent form. The design of the study was approved in the university Ethics Committee of Vice Chancellor for Research (NO: REC.1398.079).The study participants did not suffer from any systemic disease as determined by a written health history and oral questioning, they did not take any medication in the 12 h prior to the procedure that could change pain perception, and they all needed maxillary canine injection on both sides together with the completely sound canine teeth. The exclusion criteria were as follow: under 18 years old and over 60 years old, being pregnant, being allergic to local anesthetics and sulfites, active sites of pathosis in the area of injection, or inability to give informed consent.Each patient received two similar supraperiosteal injections in the labial vestibule and close to the root apexes of the maxillary canine teeth. The injection was carried out through infiltration of Lidocaine HCL 2% with Epinephrine 1:100,000  on both sides using two types of short needle tips: Transcodent painless needle tip 27G  for statistically significant difference between two means.Taking into account the dependent nature of the data and following a normal distribution, the statistical analysis was carried out using the parametric paired 3Thirty volunteers participated in this study. There were 17 women and 13 men with a mean age of 27.3 ± 6.8 years. The level of pain (VAS) in the patients was estimated immediately after the anterior maxillary infiltration injection using Transcodent painless needle tip. The mean standard deviation of this pain was 18.3 ± 10.7 mm while that using regular needle tips was over twofold higher (43.1 ± 13.1 mm).t‐test, there were significant discrepancies with respect to the pain level VAS in both groups (p < 0.001).The mean and standard deviation of the pain level discrepancy VAS in the two groups was estimated as 25.1 ± 11.6 mm, and the standard error of pain level discrepancy in both groups was the same (2.1 mm). According to the results of the paired 4In the present research, the patients' pain level VAS scores in the anterior maxillary infiltration injection were studied by comparing the Transcodent painless needle tip with regular needle tips. In accordance with the results, using Transcodent painless needle tips have a significant impact on reducing the level of pain in the patients when compared to the injection with the regular needle tips. The patients' mean pain level during the anterior maxillary infiltration injection was over twofold lower when using Transcodent painless needle tip than the regular needle tips. Due to the modern bevel design of the three‐edge lancet grinding type, the Transcodent system was claimed to improve patient's comfort and increase softness of the injections. Consequently, the patients' pain level was reduced during the injection of the analgesia. However, this claim largely by the manufacturers needed to be independently investigated.The Lancet type of cutting edges plays a crucial role in the injection needle tips. In this design, the performance of the needle tip is improved due to the concentration on the needle–tissue interface in lancet at the first moments of tissue cuts. At the same time, two distinct phases were detected on the curve of the input forces of the needle tip during the injection: in the first phase, the tissue was deformed and the force was increased without cutting the tissue. In the second phase, the tissue was cut and the force was suddenly decreased  on the intensity of pain pertinent to the subcutaneous injection of Lidocaine 1%. The higher levels of pain were reported by the patients in the bevel down position when compared to the bevel up position The results of the above‐mentioned studies demonstrated the importance of the needle tip bevel design on injection pain in patients. The results of the present study also indicated that using bevel design such as three‐edge lancet grinding was important in reducing injection pain in patients and resulted in a significant reduction of their pain when compared to the regular needle tips.Previous studies estimated the effects of different needle tip designs or other parameters on patients' pain level: Once in an experimental group and once in a separate control group. The subsequent phases of measuring the levels of pain in these research were carried out 2 weeks after the first measurements and were called the wash‐out period . Thus, the paired test has a higher statistical strength than an independent test and these tests are appropriate for the paired protocols, in which the local anesthesia group and placebo group are assessed on similar cases (Rice, To statistically analyze the level of pain in the local anesthetic injection and placebo groups, previous studies employed independent tests such as Mann–Whitney U Test or Independent es Rice, .Besides treatment‐related factors, mental variables such as fear and anxiety also affect pain intensity. It was found that patients' anxiety leads to an increase in the duration and intensity of pain (Johnson & Primosch, The pain experienced during local anesthesia injection comprises of two parts. The first is the feeling of pain upon insertions of a needle, which is short‐term pain. The secondary pain is felt upon the activation of pain recipients that reacts against chemical factors in infiltration and the damage to the tissue. The secondary feeling of pain is more intense and lasts longer (Zilinsky et al., Different criteria were employed for the measurement of pain after insertion of the needle or the injection pain. Pain is a subjective phenomenon and its intensity can be affected by various physical and mental factors. Thus, patients' anxiety should be measured and determined prior to interventions. Furthermore, pain estimation, unlike many other clinical experiments, is an experimental process with many variables that can affect the outcome. With correct design and precise explanation of the VAS criteria to the patients, this method can be a valid technique in pain estimation (Price et al., One possible limitation of this study is that patients' levels of pain should be measured immediately after the infiltration injection of the anterior maxilla. It seems that in case of separation of the levels of needle insertion related to pain from the levels of pain caused by the anesthetic solution injection, the precision of the results can be improved. On the other hand, it was claimed that the patients are incapable of differentiating these two types of pain (McPherson et al., 5The results of this randomized, split‐mouth clinical study highlighted the potential use of Transcodent painless needle for reducing the injection pain of maxillary anterior infiltrations.The authors deny any conflicts of interest.Farnoosh Razmara: Conceptualization; data curation; formal analysis; investigation; methodology; project administration; supervision; validation; visualization; writing—review and editing. Arjang Baghi: conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; validation; writing original draft. Farzaneh Afkhami: conceptualization; investigation; methodology; project administration; supervision; writing—review and editing.This study was approved by the Ethics Committee of Tehran University of Medical Sciences.


IntroductionPlatelet-Rich Plasma (PRP) is an autologous human plasma preparation with a higher platelet concentration. Injection of PRP were, found to be effective in treating tendinopathy and arthritis. A few studies only focused in using PRP injection in patients with tennis elbow. This study was conducted to access the functional outcome of PRP injection in tennis elbow patients.MethodologyA prospective study was done from June 2020 to June 2021, at R. L. Jalappa Hospital, Kolar, India among 80 individuals diagnosed with tennis elbow. All individuals aged between 18 to 65 years of either gender and the pain symptoms not subsided with oral analgesics or physiotherapy were included in this study. We analysed all the patients with a MAYO elbow performance score and Visual Analogue Pain Scale (VAS) during the follow-up period.ResultsIn total, 80 individuals participated in our study, of which the mean age of the participants was 45.54. There is statistical significance in the difference of means of pain score obtained using both VAS and MAYO score at 12 weeks and 24 weeks. There is high significant positive correlation of age with the pain scores at 12th week and 24th week after the procedure.ConclusionIn tennis elbow patients, PRP injection shows an effective reduction in pain according to VAS and MAYO score and especially, younger age patients have shown more benefit in terms of pain reduction with PRP treatment. Platelet-rich plasma (PRP) is an autologous human plasma preparation with a higher platelet concentration obtained by centrifuging a larger volume of the patient's blood. Platelets alpha granules contain a variety of growth factors and mediators , that are concentrated during centrifugation to deliver supraphysiologic levels of such growth factors and cytokines to an injury site and aid in the natural healing process ,3. SeverA prospective study was done from the period of June 2020 to June 2021, at R. L. Jalappa Hospital, Tamaka, Kolar among 80 individuals diagnosed with tennis elbow . All individuals aged between 18 to 65 years of all gender, and the pain symptoms not subsisted with oral analgesics or physiotherapy were included in the study. Patients undergone elbow surgery, diagnosed with septic arthritis, having a history of alcohol and smoking habits, mentally challenged persons, were excluded from the study. All eligible individuals have been included with informed consent. Ethical clearance was taken from the ethical committee at Sri Devaraj Urs Medical College, Tamaka, Kolar. The PRP was prepared from venous whole blood at the point of care and contained concentrated platelets three-folds. All patients underwent intra-lesional PRP injection over the lateral epicondyle at the point of maximum tenderness. We analyzed all the patients with a VAS and MAYO score during the follow-up period. The data were entered in Microsoft Excel, and results were analyzed in Statistical Package for social sciences (SPSS) IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp. The continuous variables were described as mean and standard deviations. The qualitative data were described in terms of frequency and percentage. Paired t-test was done to analyze the association between, the mean pain scale score in (VAS and MAYO) on pre and post-treatment procedures. The correlation was used to assess the relationship between continuous variables.In total, 80 individuals participated in the study. The mean age of the participants was 45.54, with a standard deviation of 10.531. The baseline characters of the study participants were shown in Figure There is no universal agreement on better PRP preparation in terms of quantity of blood components as currently a variety of commercial PRP devices are available in practice. Prior to centrifugation, whole blood is taken and mixed with an anticoagulant agent, which separates red blood cells (RBCs) from platelet-poor plasma (PPP) and the "buffy coat," which contains high concentrated platelets and leukocytes as well. Platelets are been extracted in a variety of ways and then injected into the lesion or "activated" by adding calcium chloride or thrombin, which causes the platelets to degranulate and release growth factors. The particular makeup of PRP is influenced by both patient-specific factors, such as medications used, and commercial system preparation procedures, and diversity in its composition of PRP preparations causes difficulty in understanding the evidence about the therapeutic efficacy of PRP -3,12-13.The limitations of this study, it was done in a single hospital, the results needed further evidence from other studies done in various clinical settings. Similarly, this is a hospital-based study, which invites a selection bias by the treating doctor. Thus, the results may not be applicable to the general population.In tennis elbow patients, PRP injections show an effective reduction in pain according to VAS and MAYO score and especially, the young age group has shown more benefit in terms of pain reduction for PRP treatment. Thus, PRP injections can be used as an important alternative to other standard regimens in and those who don't want surgery.


Introduction: Total knee arthroplasty (TKA) is a life-changing joint surgery that improves health-related quality of life and functional status. Patients in need of this surgery mostly belong to the geriatric age group with limited functional reserves and multiple co-morbidities requiring utmost perioperative care with the most suitable analgesic modalities. Regional analgesia (RA) should provide effective analgesia while allowing early mobility, reduced opioid consumption, and early discharge. Dual subsartorial block (DSB) is a novel procedure-specific, motor-sparing, and opioid-sparing RA technique for TKA surgeries. Our study compared the analgesic efficacy of the two different combinations of volumes used in DSB.Methods: This prospective randomized comparative study included patients between 25-75 years of age of American Society of Anesthesiology (ASA) I-II grades who underwent an elective cemented unilateral total knee replacement performed via medial approaches under neuraxial anesthesia. A total of 104 patients were divided into two equal groups based on the local anesthetic (LA) volumes (Group A 10/20 ml and Group B 20/10 ml) used in the DSB. Postoperative pain scores  and quadriceps strengths , and opioid consumption were measured at regular intervals till discharge.Results: Most patients (71.2%) remained pain-free and comfortable until discharge, while 28.8% complained of pain within 12 hours of DSB. Mean quadriceps strength remained almost normal (4-5/5) until the discharge with no incidences of buckling or fall in either group. Over time, the postoperative trend between the groups showed a significant difference for dynamic pain (p = 0.002) and quadriceps strength (p = <0.001). There was an insignificant difference (p = 0.161) between the groups regarding opioid consumption, with the median oral morphine equivalent of zero in both groups. Discussion: The effective analgesic coverage of DSB is based on the involvement of all innervations of the procedure-specific pain generators of TKR surgeries. The specific focus on selective sensory innervations and the type/volume of the LA used makes DSB a motor-sparing RA alternative that facilitates early mobility and discharge. It can provide effective postoperative analgesia without compromising the motor strength of the quadriceps muscle when administered in either 10/20 or 20/10 volumes. Osteoarthritis (OA) is the leading cause of disability in older adults . It is tA well-functioning knee joint makes a significant contribution to the quality of life. Total knee arthroplasty/replacement (TKA/TKR) is the ultimate treatment option for end-stage OA of the knee joint to improve health-related quality of life and functional status . It is tThe dual subsartorial block (DSB) is a novel procedure-specific and motor-sparing RA technique that may reduce overall postoperative opioid consumption when used in conjunction with MMA -28. In oWe aim to compare the analgesic effects and functional consequences of two different volumes used in the DSB in consecutive patients who met the inclusion criteria. We hypothesize that DSB would provide the desired procedure-specific, motor-sparing, and opioid-sparing analgesia when utilized in 10-20 ml volumes for each injection. We propose a new paradigm and an alternative RA technique to improve the quality of post-TKR analgesia until the discharge, facilitating ERAS.PatientsThe inclusion criteria of our study comprised patients of either sex between 25-75 years of age with American Society of Anesthesiologists (ASA) I-II grades who underwent an elective cemented unilateral TKA/TKR with varus knee or mild valgus deformity performed via medial approaches by a single arthroplasty surgeon under neuraxial anesthesia.The exclusion criteria of our study included patients with ASA III/IV grade, severe valgus deformity, acute/chronic kidney disease, neurological deficit, cognitive dysfunction, any contraindications for the neuraxial blockade, coagulopathy, chronic opioid consumption , operative limb neuropathy, hypersensitivity and/or allergies to local anesthetic (LA) or any of the study medications, or patients who underwent TKA other than medial approaches, bilateral TKA, or patient refusal in study participation.Sample size estimationThe number of participants to be included was calculated based on the pilot study  conducteThe sample size required in each arm of the study was calculated according to the formula:Sample size N = 2(zα + z1-β )2 σ2 / δ2Where σ (Pooled SD) = 1.12, δ (Difference of Means) = 0.8, Type I error (α) = 5%, Zα = 1.96, Type II error (β) = 5%, Power (1 - β) = 95%, and Z1-β = 1.65. So, based on the formula given above, using the mentioned values, the sample size required is: 2*(1.96 + 1.65)2*1.122/0.82 = 51.08. Thus, assuming 95% power and 95% confidence interval, the inclusion of 52 patients in each group  was considered sufficient to observe a significant difference between both groups.Details of study designAfter approval by the Institutional Review Board (IRB/GH/Anaes/02/2019/003) and written informed consent, 104 patients were allocated into two equal groups (52 patients each) based on the volumes used in the DSB.1. Group A: 10 ml in the distal femoral triangle and 20 ml in the adductor canal.2. Group B: 20 ml in the distal femoral triangle and 10 ml in the adductor canal.This clinical trial was registered in the Clinical Trial Registry of India  as a prospective trial . It was conducted between May 2019 (first case enrolment from 01/05/2019) and May 2021 (about 24 months) as a prospective, double-blind, monocentric study and randomized comparative trial.Methods of randomization and blindingComputer-generated randomization. Aside from the researchers performing the blocks, all other investigators, anesthetists, surgeons, physical therapists, nurses, and the study participants were blinded to the randomization of each subject.Patient preparationPreoperatively, approximately 10 ml/kg Ringer’s lactate solution was given to the patients according to their hemodynamics after securing intravenous access. All patients were premedicated with intravenous 0.3 mg ramosetron and 8 mg dexamethasone as an antiemetic medication.Intraoperatively, routine anesthetic monitoring was conducted using non-invasive blood pressure, pulse oximetry, and electrocardiography. All patients received spinal anesthesia performed in standard fashion (L3-L4) using 10-15 mg of hyperbaric bupivacaine 0.5%. All patients were sedated by 0.01 mg/kg midazolam, when necessary, intraoperatively. Intraoperative tourniquet pressure and duration were noted.Immediately after completion of surgery and application of dressing, an experienced anesthesiologist (with more than five years of experience in ultrasound-guided RA techniques) performed ultrasound-guided DSB using prepared LA solution (0.2% ropivacaine + 8 mg dexamethasone).Postoperatively, all patients were kept under observation in the high dependency unit for 24 hours for postoperative monitoring and pain management. During the entire hospital stay, the patients were continued on the pharmacological regimen Table .DSB techniqueFor DSB, the LA solution was deposited under the sartorius muscle  with two injections  that combined two subsartorial blocks: the distal femoral triangle block (FTB) and the adductor canal block (ACB). The DSB was given in three steps ,28.Identification of the Apex of FTA high-frequency linear ultrasound probe  was placed anteromedially over the mid-thigh location Figure .First Injection The probe was moved 1-2 cm proximal to the apex of FT and kept over the distalmost part of the FT. The sonoanatomy revealed sartorius muscle (STM) above the femoral vessels, the vastus medialis muscle (VMM) anterolaterally, and adductor longus muscle (ALM) posteromedially. Between STM and VMM, hyperechoic saphenous nerve (SN) lateral to the femoral artery (FA) and the nerve to vastus medialis (NVM) lateral to the SN were identified. A 100-mm, 22-gauge Stimuplex A needle  was inserted in-plane from the lateral-to-medial direction in the plane between STM and VMM. The LA mixture was deposited targeting SN and NVM, separating the plane between VMM and STM Figure .Second Injection (ACB)After the first injection, the probe was moved distally to re-identify the apex of the FT and then placed 1-2 cm distal from it over the proximal AC. The bilayered appearance of the lower border of STM was noted due to the vasoadductor membrane (VAM). The LA mixture was deposited besides FA under the VAM, sometimes resulting in compression of the FA Figure .Patient assessment and data collectionPostoperative pain scores (resting and dynamic) were measured using a visual analog scale (VAS) at regular intervals till the discharge of the patient. The quadriceps strengths were also measured periodically by a neurological exam, based on a 6-point (0-5) scale from the Medical Research Council (MRC)  . The conPrimary and secondary outcomes were as shown in Table Statistical methodsThe data was encoded and recorded in an MS Excel spreadsheet program. The statistical analysis was carried out with SPSS v23 . Descriptive statistics were generated in the form of means/standard deviations and medians/interquartile ranges (IQRs) for continuous variables and frequencies and percentages for categorical variables. The data were presented graphically using histograms/box and whisker plots/column charts for continuous data and bar charts/pie charts for categorical data Figures . Group cThe assignment of patients in study groups is shown in Figure We found effective equivocal analgesia provided by DSB in both groups. The majority of the patients remained comfortable and pain-free till discharge, with a mean VAS score of less than 3 in both groups Figures -5. In reThe mean quadriceps strength remained almost normal (4-5/5 grade) until the discharge of the patients Figures -7, with The mean (SD) of tourniquet pressure (mmHg) in Group A was 283.75 (17.57), and Group B was 282.60 (22.87). The mean (SD) of tourniquet duration (minutes) in Group A was 51.63 (13.07), and Group B was 49.67 (14.16). There was no significant difference between the groups regarding tourniquet pressure  or tourniquet duration .We found a weak negative but insignificant correlation between postoperative pain and tourniquet duration at four hours , six hours , and eight hours . We also found weak positive but insignificant correlation between postoperative pain and tourniquet pressure at four hours , six hours , and eight hours  Figure .In our study, we compared two different volumes of LA in two different components of DSB  to assess its analgesic efficacy when used as an adjunct to MMA in the postoperative period. The DSB can also be classified as a precision RA technique as it targets specific neural elements using LA of fixed volumes and concentration at fixed locations. Optimal analgesia provided by DSB as an important MMA component helped reduce the additional opioid consumption making DSB an opioid-sparing RA option. We found significantly retained quadriceps muscle strength in both groups with no evidence of buckling or falls. It allowed our patients to continue physiotherapy and pain-free mobilization, promoting early hospital discharge. Thus, making the DSB a motor-sparing RA alternative among available techniques.DSB is also classified as a procedure-specific block as it covers both anterior and posterior knee innervations of all pain generators involved in the surgical dissection -28. The Pain scores (rest and the dynamic) of both groups showed effective and equivocal analgesia throughout the postoperative period, possibly due to the broad coverage of all procedure-specific innervations by DSB. The first injection of DSB targets SN and NVM directly and the subsartorial plexus (SSP) and peripatellar plexus  indirectly through the drug distribution. Thus, it covers the innervation of the anterior knee components ,28. The The desired results of the DSB depend on the understanding of the anatomy of two prominent landmarks in the thigh (FT and AC) separated by the FT apex to locate target-specific innervations -28. The Another important outcome of our study was to assess the motor-sparing effect of DSB at regular intervals postoperatively until discharge of the patient. We found significantly preserved quadriceps muscle strength in both groups in all study time points without any incidences of fall or buckling after DSB administration. However, there was an initial decrease in quadriceps strength in both groups during the first recording at the sixth hour after DSB, possibly due to the residual effects of the neuraxial anesthesia. We believe that the limited range of motion due to chronic osteoarthritic changes in the knee joint can lead to quadriceps weakness or reduced baseline quadriceps strength. However, we could not record preoperative (baseline) quadriceps strength to compare the changes before and after surgery, as such comparison would be beyond the scope of this study. Quadriceps strength may also decrease following knee surgery or commonly used RA techniques. Some studies documented less decreased quadriceps power following ACB than FNB , while oThe motor-sparing effect of DSB is mainly due to its components , selective motor sparing neuronal targets, and choice of LA used. Distal FTB may decrease quadriceps strength due to proximal drug spread involving the femoral nerve (FN) ,40,46,47In DSB, we selectively targeted terminal nerves preserving motor branches that further contributed to the motor-sparing effect of this block. Johnston et al. , in theiThe other motor-sparing RA options for the TKR included FTB, ACB, iPACK, modified 4-in-1 block, and local infiltration analgesia (LIA). The FTB or ACB alone may not cover the innervations of all procedure-specific pain-generating components, resulting in ineffective or partially effective analgesia. In ultrasound-guided modified 4-in-1 block , 5-7 ml Some patients (30 out of 104) in our study developed significant pain postoperatively, requiring rescue analgesics in the form of opioids with or without rescue blocks. We had identified the likely cause of the pain by assessing the type and actual pain location. The most common location of the pain within the six hours of DSB was the proximal thigh, suggesting tourniquet-related pain due to regression of the spinal level. The tourniquet pain, being an inflammatory type, requires perioperative anti-inflammatory pain medications. We found no significant correlations between thigh pain with the duration and pressure of the tourniquet during surgery. The confounding factors affecting the outcome of the block when the likely cause of the pain was an “inadequate block” are the sonoanatomy image quality at the time of the block, difficulty in identifying target structures, and the experience of the regional anesthetist. Our focused pain assessment and determination of the rescue technique as per the pain location (pain location mapping) helped us identify and target specific spared innervations in rescue blocks. The rescue block for Location 2a (upper incision-NVM territory) was FTB targeting only NVM, for Location 2b (lower incision-SN territory) was FTB targeting only SN, and Location 3  was ACB depositing drug below the VAM. For other locations, only rescue opioids were given without blocks.The role of opioids in postoperative analgesia is like a double-edged sword: oligoanalgesia at lower doses and analgesia at the expense of potential complications at higher doses. However, lower doses with MMA help reduce undesirable side effects without compromising the analgesic profile. A low maintenance dose of opioids helps manage chronic pain components associated with the osteoarthritic changes in the knee joint prior to the surgery. In our protocol, we included a transdermal patch of buprenorphine 5-10 mg to meet the low maintenance dose of opioids. Our comparative study showed almost no need for additional opioids as rescue analgesia, making DSB an opioid-sparing RA option. It facilitated early discharge from the hospital by avoiding opioid-related side effects while maintaining an effective analgesic profile with MMA. The individual components of DSB (FTB and ACB) are also known to reduce opioid consumption ,65-67. TPerioperative pain management for patients undergoing TKR is complex and challenging. A holistic approach is required to manage such multifactorial postoperative pain taking into account the patient’s age, comorbid factors, complex innervations of pain generators, the demand for the most appropriate analgesic option, enhanced recovery, and early mobilization. Such an approach helped us keep our patients’ overall satisfaction score of 4/5 (very good) at discharge with the existing analgesia protocol.Despite the strength of our study, including randomization and double-blind design to avoid biases and assessment of all study parameters till the discharge of the patient, our study has several limitations. One of the limitations is its monocentric design and inter-operator variability, potentially leading to inconsistency in the efficacy of the RA performed. Another limitation is the lack of a control group. Although the sample size was calculated statistically, we can not generalize our observations to all TKR surgeries with a limited number of patients included in this study. Unmeasured confounders such as individual muscle mass may have influenced LA spread and motor strength. It would have posed a significant methodological hurdle and external validity problems if we had adjusted anthropometric dimensions to overcome this problem.In conclusion, DSB with the volumes of 10/20 or 20/10 ml (in FT/AC regions) can provide equivocal and effective postoperative analgesia without compromising the motor strength of the quadriceps muscle, thus allowing implementation of the ERAS protocol for TKR surgery. Correctly applying this novel technique requires focusing on the target structures, using LA at the recommended volume and concentration, and identifying the injection sites as described. Any change to any of this information can lead to unsatisfactory results. This new innovative technique requires prospective multicenter randomized controlled trials with larger samples sizes for better corroboration of the results. Also, the best and optimal volumes for DSB need further study.


Preoperative anxiety and postoperative pain are frequent in cardiac surgeries and constitute important stressors for patients, which can cause several complications. One strategy that aims to alleviate these phenomena is listening to music as a non-pharmacological intervention. The aim of this study is to evaluate the effect of listening to music on preoperative state-anxiety, postoperative pain, at rest and when instructed to cough, and cardiorespiratory parameters in patients undergoing cardiac surgery.Randomization.com website. The sample size calculation was obtained after conducting a pilot study.A randomized, parallel, simple masking clinical trial will be conducted with patients 18 years of age or older who have undergone elective cardiac surgery by sternotomy, who agree to participate in the research and sign a free and informed consent form. Study participants will be randomly divided, in a 1:1 ratio, to one of the two groups: experimental (subjected to listening to music for 20 min in the pre- and postoperative period) or control (standard care in the pre- and postoperative period), using a randomization scheme generated by the The results of the study may contribute to the implementation of non-pharmacological interventions in health services, highlighting the protocols for listening to music, to minimize anxiety and pain in cardiac surgery.RBR-8mdyhd. Posted on December 10, 2019ReBEC The online version contains supplementary material available at 10.1186/s13063-022-06233-9. Cardiac surgery is the treatment of choice for many patients with cardiovascular diseases, which are one of the main causes of morbidity and mortality in developed and developing countries. For patients who undergo this surgery, in addition to the pathophysiological aspects, there is also an emotional impact, since the complexity of the procedure and its critical nature can cause anxiety, stress, and depression .Therefore, the psychological component must be inserted in effective preoperative preparation, highlighting the performance and the most active intervention of nursing teams. Preoperative evaluation is essential, starting with contact between nurses and patients, and continuing throughout the surgical process. It must be a complete, holistic assessment, which will result in the formulation of nursing diagnoses and intervention decisions .Anxiety is the most common emotion before cardiac surgeries, and a common nursing diagnosis. Nurses’ preoperative visits are an indispensable procedure, which helps in the psychological preparation of patients and outlines strategies for success of, and fewer complications in, the procedure, both intra and postoperative .Of all types of surgeries, cardiac is the least psychologically accepted by patients, generating high levels of anxiety in the preoperative period, possibly due to the cultural association of the heart as an organ related to life, death and the generation of feelings. The symbolic consideration of the heart and the fear associated with death lead to emotional distress in patients, which can cause complications in the postoperative period .Some studies have evaluated the correlation between preoperative anxiety and postoperative pain in several surgical procedures –7. SeverCurrently, the use of multimodal analgesia is recommended to ensure greater efficacy in relieving postoperative pain when compared to single-mode interventions . Among nSeveral studies conducted with different objectives have evaluated the effects of musical intervention on the following: pain and anxiety in surgery of patients with breast cancer ; stress In the context of cardiac surgeries, research that has analyzed the effects of musical intervention have had conflicting results. A quasi-experimental study in Turkey showed that pain after open heart surgery decreased in patients who listened to music compared to those who did not. Oxygen saturation also increased significantly within the music group, but there was no difference in other physiological parameters . In a suHowever, although other authors  have fouIn light of the above, the relevance of this research is that it can serve to minimize existing gaps and add scientific knowledge to the specific area. It is also worth highlighting the importance of evaluating the results of music intervention in postoperative pain, not only at rest, but also when coughing, as this is an important activity in the prevention of complications after cardiac surgery that should be encouraged in the postoperative period. Coughing is one of the activities expected in the postoperative period. It is important because it eliminates the accumulation of pulmonary secretions, thus minimizing the risk of infections and other respiratory complications and reducing the possibility of prolonged surgical recovery. However, the activity of coughing is also considered painful , 27.The hypothesis to be tested in this clinical trial is the following: listening to music in patients undergoing cardiac surgery will promote reduction of the average of anxiety-state scores in the immediate preoperative period; reduction of the average of intensity scores for pain, at rest and when instructed to cough, on the first postoperative day; and reduction in mean systolic and diastolic blood pressure, and heart rate, respiratory rate, and increase in mean oxygen saturation, in the immediate preoperative period and on the first postoperative day.Therefore, this study has the general objective of evaluating the effect of listening to music on preoperative anxiety-state; postoperative pain, at rest and when instructed to cough; and cardiorespiratory parameters in patients undergoing cardiac surgery.Compare anxiety-state scores between the experimental and control groups in the immediate preoperative period for patients undergoing cardiac surgery;Measure the intensity of acute pain, at rest and when instructed to cough, on the first postoperative day, and identify its location in patients undergoing cardiac surgery;Compare pain intensity scores, at rest and when instructed to cough, between the experimental and control groups, on the first postoperative day of patients undergoing cardiac surgery;Compare cardiorespiratory parameters  between the experimental and control groups, in the immediate preoperative period and on the first postoperative day of patients undergoing cardiac surgery;Compare intra-group, preoperative anxiety-state scores, postoperative pain scores, at rest and when instructed to cough, and cardiorespiratory parameters  in patients undergoing cardiac surgery;To verify the correlation between preoperative anxiety-state and intensity of postoperative pain in patients undergoing cardiac surgery.The specific objectives of the clinical trial are:The study will be a single-centered, randomized, parallel, superiority clinical trial with simple masking and will follow the Consolidated Standards of Reporting Trials (CONSORT) Declaration—extension for randomized clinical trials of non-pharmacological treatments .This clinical trial protocol was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines , as evidThe study will be developed at the surgical clinic unit and coronary intensive care unit (ICU) of the Hospital de Clínicas of the Federal University of Triângulo Mineiro (HC-UFTM), located in Uberaba, Minas Gerais, Brazil.The study will include patients who will undergo elective cardiac surgery, who are 18 years old or older, of both sexes.Patients with hearing impairment and/or cognitive impairment , patients who are using sedative and/or anxiolytic drugs at the time of data collection in the immediate preoperative period, and those who are unable to maintain a dialogue with the researcher to answer the items on the data collection instrument will be excluded from the study.Patients who met the study criteria and agreed to participate in the research, and were given details about the study, will sign a free and informed consent form.Randomization.com (http://randomization.com).Study participants will be randomly allocated, in a 1: 1 ratio, to one of the groups, experimental (with music listening) or control (without music listening). The randomization scheme will be generated by using the website After randomization, a list will be generated, numbered sequentially, for the allocation of participants to the research groups. To ensure concealment of the allocation, the groups to which participants are assigned, according to the generated list, will be inserted in opaque envelopes and numbered sequentially. These envelopes will be sealed and stored in a safe place. They will only be opened by the statistician, at the time of application of music listening or standard care for the corresponding participants. The entire process of randomization and concealment of the allocation will be carried out by the statistician, who will have no clinical involvement in the study.The clinical trial will be conducted with simple masking, since the researchers responsible for applying the data collection instrument and measuring the variables studied, as well as the surgical and the prescribing teams, will be masked as to the allocation group of each patient. However, due to the nature of the intervention, it will not be possible to mask the research participants, considering that they will be aware of being part of the experimental group, while they are submitted to listening to music.The non-pharmacological intervention to be evaluated will be listening to music for 20 min, in a 20-min intervention in the immediate preoperative period and another 20-min intervention on the first postoperative day.The Joanna Briggs Institute, an international research and development organization, synthesized the best available evidence on the use of music as a therapeutic intervention for the management of anxiety or pain related to surgical interventions. They recommend the use of light, non-lyrical music, with 60 to 80 beats per minute, in low tones, preferably strings, with minimal percussion and a volume of 60 dB .The pieces selected for this research, as well as their order, was part of a collection used in a clinical trial on anxiety in blood donors , which rPiece No. 1: Cello Suite No.1, Prelude/Composer: Johann Sebastian Bach (1685-1750)/Instrument: celloPiece No. 2: Nocturne. Op. 9 No.2/Composer: Frédéric Chopin (1810-1849)/Instrument: pianoPiece No. 3: Clarinet Concerto in A Major K 622 Adagio/Composer: Wolfgang Amadeus Mozart (1756-1791)/Instruments: orchestra and clarinetPiece No. 4: Gymnopédie No.1/Composer: Erik Satie (1866-1925)/Instrument: pianoPiece No. 5: The Carnival of the Animals - Le Cygne/Composer: Charles-Camille Saint-Saëns (1835-1921)/Instruments: piano and celloThe repertoire, which totals 20 min and 28 s, consists of five pieces of classical instrumental music from the Baroque, Classical and Romantic periods, composed between the eighteenth and nineteenth centuries. They are:The sequence of the songs considered a plan to initially have selections with more active, faster elements, matching the level of activity and stress of the listeners, and gradually moving on to slower, less stimulating, more relaxing selections .Classical pieces have common elements of relaxing, calming music, so they are often used in recordings for relaxation .The patients in the experimental group will undergo listening to music in the immediate preoperative period (up to 24 h before surgery) and on the first postoperative day (24 to 48 h after surgery), totaling two music listening sessions for each patient.Each music listening session will have a duration of 20 min and will be carried out on headphones with an SD card containing the music recording. The intervention will be conducted by the researcher, who will adjust the volume of the headset, instruct the patients to stay in a comfortable position in the bed, with their eyes closed, and then start listening to the music. The length of the music listening will be timed by the researcher.Patients in the control group will receive standard care in the immediate preoperative period and on the first postoperative day. Standard care will consist of bed rest/sitting in an armchair with routine care, for 20 min, timed by the researcher.The intervention with a given participant will only be discontinued upon completion of the study, or their request to withdraw their consent to participate in the study.The study will not interfere with the pharmacological strategy and care of patients, who will receive medications and procedures according to the medical prescription protocol of the study field institution. Information related to painkillers administered to participants will be inserted in the data collection instrument.Data collection will take place at the patient's bedside, once a day, in the immediate preoperative period (up to 24 h before surgery) and on the first postoperative day (24 to 48 h after surgery). The data related to the anesthetic-surgical procedure will be collected from the patient's medical record.No data will be collected in the immediate postoperative period (first 24 h after surgery), since in this period, patients may still be experiencing residual anesthetic effects, making data collection unfeasible.The data collection instrument, developed specifically for this study, was submitted to content validation by five judges with PhDs, and relevant experience in the fields of nursing, teaching and evidence-based research. The instrument will be filled out by a researcher responsible only for data collection, with no participation in the application of the intervention to the participants.Part I—Identification, sociodemographic and clinical data: initials of the patient's name, medical record number, date of birth, age, sex, ethnicity, location of residence, education, presented comorbidities, previous cardiac surgery, and classification of physical status according to the American Society of Anesthesiologists .Part II—Refers to the evaluation in the immediate preoperative period: preoperative time; and the following data will be collected before and after the music intervention or standard care: anxiety-state score according to the State-Trait Anxiety Inventory-State (STAI-State), heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation.Part III—Data regarding the anesthetic-surgical procedure, to be obtained from the patient records: surgery performed, anesthetic block, duration of general anesthesia, use of cardiopulmonary bypass, duration of cardiopulmonary bypass, duration of surgery, duration of the anesthetic-surgical procedure, complications in the operating room, and placement of a catheter for postoperative analgesia.Evaluation of postoperative pain, with the patient at rest and after being instructed to cough: presence of pain, location of pain, pain intensity according to the Numerical Scale, and classification of pain intensity;Values for heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation.Part IV—Refers to the evaluation on the first postoperative day. Information on postoperative time, extubation time, presence of chest drains and prescribed analgesic regimens will be obtained. After applying the Ramsay sedation scale, if the score is ≤ 3 points, the following data will be collected before and after the music intervention or standard care:The instrument contains four parts:To assess preoperative state-anxiety, the STAI will be used, prepared by Spielberger, Gorsuch e Lushene , translaFor each statement, whose weight varies from one to four points, the individuals must indicate how they feel, indicating one of the four available alternatives; total scores range from 20 to 80 points on each scale .The present research will evaluate only state anxiety, since the objective is to evaluate the level of anxiety in the period before the surgery.When applying the scale, it should be made clear to the patients that there are no right or wrong answers to the questions and that the answers must correspond to one of the options given . In the To calculate the total score, a sum must be derived by adding up the scores for the answers given to each question. However, for positive questions, the score must be inverted, that is, if the patient answers 1, a value of 4 is assigned; if they answer 2, a value of 3 is assigned; if they answer 3, a value of 2 is assigned; and if they answer 4, a value of 1 is assigned. On the STAI-State scale, the positive questions that should be scored in reverse are as follows: 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 .Previous research has found that the scores on the State-Anxiety scale increase in response to various types of tension and decrease as a result of relaxation training .As for cardiorespiratory parameters, a portable pulse oximeter will be used to measure heart rate and oxygen saturation; breathing movements will be observed and counted for 1 min to check the respiratory rate. The measurement of systolic and diastolic blood pressure will be performed by the indirect method of measurement with the auscultatory technique, using a stethoscope and calibrated adult aneroid sphygmomanometer. The blood pressure measurement technique will follow the recommendations of the Brazilian Guidelines on Hypertension .To quantify the intensity of postoperative pain, the Numerical Scale with 11 points will be used, graded from 0 to 10, where 0 means no pain and 10 means the worst pain ever felt. This is one of the validated scales for assessing pain intensity . The NumPain intensity will then be classified as: no pain (0), mild pain (1 to 4), moderate pain (5 to 7), and severe pain (8 to 10) .To carry out the data collection, a team will be created, consisting of three nurse researchers linked to the Study and Research Group on Evidence-Based Practice and Patient Safety at UFTM.One of the researchers will recruit the participants, allocate them to the groups, and conduct the music intervention, or time the standard care time. The other researchers will be responsible for collecting the information in the medical records and for applying the data collection instrument to the patients, before and after the intervention or standard care, in the pre- and postoperative period.Before the start of data collection, the team will be trained in the entire process and the instruments to be used, to guarantee standardization and the correct execution of the procedures.For recruitment, every week the researcher will initially obtain from the Cardiovascular Unit of HC-UFTM the identification of the patients who will be submitted to the cardiac surgical procedure, the date of hospitalization, and the date of surgery.To encourage the recruitment of participants in order to obtain the target sample size, the research will have the support of the institution that is the site of study. Also, the researchers will try to motivate the participants by informing them about the relevance of the research and the need for their involvement in order to help scientific progress occur.In the immediate preoperative period, in the hospital ward, patients who meet the inclusion criteria will be informed about the research. After receiving detailed information about the study, those who agree to participate will sign two copies of a free and informed consent form, one for the researcher and another for the patient.After that, the identification, sociodemographic and clinical data of the patients will be collected, followed by the assessment of the state-anxiety level, by applying the STAI-State, and the measurement of the cardiorespiratory parameters .Then, the intervention will be applied (listening to music for 20 min) for patients in the experimental group, or standard care (routine care) for patients in the control group.After the intervention or standard care, the instruments for assessing the state-anxiety level and cardiorespiratory parameters will be applied again.On the first postoperative day, in the Coronary ICU, data related to the anesthetic-surgical procedure and information on postoperative time, extubation time, presence of chest drains, and analgesic regimen prescribed on the day will initially be collected.Then, the Ramsay sedation scale will be applied, and if the score presented by the patient is ≤ 3 points, the instruments for assessing pain (at rest and when instructed to cough) and cardiorespiratory parameters will be applied.For pain assessment, first with the patients at rest, they will be asked about the presence of pain. If the answer is positive, they will be asked to indicate the location and assign a score for the intensity of their pain, from 0 to 10, according to the Numerical Scale, where 0 means no pain and 10 the worst pain ever felt. So, the pain will be classified as mild, moderate, or severe.The patients will then be asked to rest their hands on their abdomens, inhale deeply, and cough. They will be asked about the presence of pain when coughing, and if the answer is positive, they will be asked to indicate the location and assign a score for the intensity of their pain, from 0 to 10, according to the Numerical Scale, where 0 means absence of pain and 10 the worst pain ever felt. So, the pain will be classified as mild, moderate, or severe.After measuring the cardiorespiratory parameters, the intervention will be applied (listening to music for 20 min) for patients in the experimental group, or standard care will be provided for patients in the control group.After the intervention or standard care, the instruments for pain assessment (at rest and when instructed to cough) will be applied again, according to the procedure described and the cardiorespiratory parameters.Once a week, the research coordinator will check the consent forms and check the quality of the data collected by the instruments. After meeting with the coordinator, two researchers from the team will enter the data in an Excel® spreadsheet, which will be stored in a password-protected computer, by double entry, to guarantee the validation of the data. Only researchers will have access to the electronic database, collection instruments and consent forms.The flowchart for the research participants is shown in Fig. To prevent cross-contamination, the team responsible for data collection will perform hand hygiene before and after the procedures; all equipment that comes into contact with the patients will be disinfected with 70% ethyl alcohol ; and aftDuring the pandemic period for the new coronavirus, all biosafety protocols will be strictly followed, and the data collection team will use all appropriate personal protective equipment, such as N95 masks, face shields, disposable aprons, gloves, and caps. Patients will also wear disposable masks during collection in the pre- and postoperative period.As for adverse events, their occurrence is not predictable in this research, given the nature of the intervention and the lack of description in the literature of adverse events resulting from listening to music. However, in the event of any complications or adverse events for the participants, the information will be recorded and the Research Ethics Committee will immediately be notified.Preoperative anxiety-state: Refers to the average reduction (difference) in anxiety-state scores, obtained after subtracting the scores, before and after intervention or standard care, in both groups , in the immediate preoperative period.Systolic blood pressure: Refers to the mean reduction (difference) between the values of systolic blood pressure, obtained after subtracting the values, before and after intervention or standard care, in both groups , in the immediate preoperative period and on the first postoperative day;Diastolic blood pressure: Refers to the mean reduction (difference) between the values of diastolic blood pressure, obtained after subtracting the values, before and after intervention or standard care, in both groups , in the immediate preoperative period and on the first postoperative day.Heart rate: Refers to the average reduction (difference) between the heart rate values, obtained after subtracting the values, before and after intervention or standard care, in both groups , in the immediate preoperative period and on the first postoperative day;Respiratory frequency: Refers to the average of the reduction (difference) between the respiratory frequency values, obtained after subtracting the values, before and after intervention or standard care, in both groups , in the immediate preoperative period and on the first postoperative day;Oxygen saturation: Refers to the average increase (difference) between the oxygen saturation values, obtained after subtracting the values, before and after intervention or standard care, in both groups , in the immediate preoperative period and on the first postoperative day;Postoperative pain: Refers to the mean reduction (difference) of pain scores at rest and when instructed to cough, obtained after subtracting the scores, before and after intervention or standard care, in both groups , on the first postoperative day.α = 0.05 and a type II error β = 0.2 were considered, reaching a statistical power of 80%.The sample size calculation was performed by a statistician without clinical involvement in the research and obtained after conducting the pilot study, using the Power Analysis and Sample Size (PASS) version 13.0 software. It should be noted that the participants in the pilot study will not be part of the main study. A type I error For the pilot study, 13 patients were analyzed, 7 patients from the control group and 6 from the experimental group. The specific objective no. 1 was used to determine the sample size and, considering preoperative anxiety-state as the primary outcome, the mean reduction in the STAI-State scores for the experimental group was 5.67 points (standard deviation: 5.89), and for the control group, it was 3.00 points (standard deviation: 7.30). Based on these values, the sample size calculated is 196 participants, that is, 98 per group.The estimated dropout rate (loss to follow-up) is 27.8%, considering the data obtained in the pilot study. The sampling loss will be included in a randomization list, and if there is attrition in either of the two evaluated groups, new participants will be included based on this list, until the loss is exhausted. It should be noted that if additional participants are to be randomized to maintain the sample size, each new participant will be randomly assigned to one of the groups with the same original allocation ratio (1:1).The collected data will be entered in a Windows® Excel® spreadsheet, using the double entry technique, for later validation. The identification of each study participant, as well as their allocation group, will be done using codes. Then, the validated database will be imported into the Statistical Package for the Social Sciences (SPSS) version 21.0 for processing and analysis.t-test will be used for independent samples in quantitative variables and the chi-square test of homogeneity for categorical variables.The normality of the data will be verified by the Kolmogorov-Smirnov test or by the Shapiro-Wilk test. To test the hypothesis of homogeneity of the two groups , when applicable, Student’s The univariate exploratory analysis of the data will be performed by the distribution of absolute and relative frequency for categorical variables and measures of central tendency (mean and median) and of variability (amplitudes and standard deviation) for quantitative variables.t-test for independent samples will be used, when applicable.To compare the anxiety-state scores, cardiorespiratory parameters, and pain intensity scores, at rest and when instructed to cough, between the experimental and control groups, Student’s t-test will be used, when applicable.To compare the anxiety-state scores, cardiorespiratory parameters and pain intensity scores, at rest and when instructed to cough, within each group, experimental and control , a paired Subgroup analysis will be performed and, if there is a violation of homogeneity of the groups for one or more confounding variables, a corresponding post hoc multivariate analysis will be performed.To check the correlation between preoperative anxiety-state and intensity of postoperative pain, Pearson's correlation coefficient will be used, if applicable.α = 5% and a confidence interval of 95%. The data will be presented in tables and figures.This research will consider a level of significance of The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Resolution No. 466, of December 12, 2012, of the National Health Council, Brazil, which deals with the regulatory guidelines and standards for research involving human subjects .The research project was registered and authorized by the Teaching and Research Management of HC-UFTM and approved by the HC-UFTM Research Ethics Committee under Opinion No. 3,474,676, CAAE: 16210819.6.0000.8667. This research was registered in the Brazilian Clinical Trials Registry (ReBEC) platform under number RBR-8mdyhd (UTN: U1111-1238-1227).Participants will be provided with complete information regarding the research, such as objectives, procedures, risks, and benefits, as well as clarification regarding voluntary participation and the possibility of withdrawing from the study at any time without prejudice to treatment. After reading the clarification form, the participants will sign two copies of a free and informed consent form, one for the participant and one for the researcher.To minimize the risk of loss of data confidentiality, participants will be identified in the survey by codes. At no time will personal data or any information that can identify participants be disclosed.All documents generated as a result of the research, such as data collection instruments and forms, will be kept in a safe place, with restricted access. After the completion of the clinical trial, they will remain on file for 5 years, and will then be incinerated, under the responsibility of the coordinating researcher.It should be noted that any necessary and significant modifications to the study protocol will be documented as an amendment to the protocol and should be formally reported to the Research Ethics Committee, the Brazilian Clinical Trials Registry platform, and the journal in which the protocol is published.The final data set will not be restricted to researchers and will be made available to the editors and reviewers of the journals, if requested.This care will not be necessary in the study. In the event of damage or loss to any participant as a result of their participation in the research, due assistance and compensation, determined by the institution's Research Ethics Committee, will be made available.The results of the study will be disseminated to the academic and professional community, through release of public access to the thesis, publication of scientific articles, and presentation of papers at scientific events.This is a protocol for a controlled, randomized clinical trial, with simple masking, that aims to evaluate the effect of listening to music on preoperative state-anxiety, postoperative pain, at rest and when instructed to coughing, and cardiorespiratory parameters in patients undergoing cardiac surgery. This research is justified, in view of the growing number of cardiac surgeries, the complexity of these procedures, the various complications that can be caused by preoperative anxiety and postoperative pain after these surgeries, and due to the need to evaluate and measure these phenomena, as well as proposing non-pharmacological interventions for the relief of patients.The study is feasible, safe, does not require invasive procedures, and does not interfere with the treatment established for the participants. The intervention will be applied pre- and postoperatively through headphones containing a collection of classical music, pre-selected by the researchers, totaling 20 min and 28 s. The research is also relevant, due to the need for new studies to evaluate the effect of listening to music in the context of cardiac surgery, since the results presented in previous research in the area have not been conclusive, requiring more evidence.One aspect that also deserves to be highlighted is the fact that the clinical trial evaluates the effect of listening to music on pain, not just when the participants are at rest, but also when they are instructed to cough. This allows a more comprehensive analysis of the intervention’s effectiveness. However, the research has some limitations. It does not allow the participants to choose the pieces to listen to, which may interfere with the outcomes. Also, the listening sessions may not be long enough to generate satisfactory results. In addition, the participants will not be masked, so they will be aware of receiving the intervention. Last, the history of the participants regarding treatment for anxiety and pain before hospitalization will not be considered.It is hoped that the results of this clinical trial will provide evidence that will contribute to supporting the development and implementation of non-pharmacological interventions, specifically listening to music, in health care, to minimize anxiety and pain, which are considered relevant stressors for surgical patients.Study protocol version 2 of July 29, 2019. Recruitment of participants will start in November 2021, and this stage is expected to be completed in October 2023.Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. A completed SPIRIT checklist with page numbers next to each item corresponding to where it is found within the protocol.


To evaluate the outcome of a knowledge, attitude, belief, and practice mode (KABP) in the pain management in patients with acute traumatic fractures complicated with alcohol dependence. Fracture Type. Six cases of spinal burst fractures and 23 cases of limb trauma fractures. Ten patients were treated with routine nursing (control group), and 19 patients were treated with pain management in KABP mode . The control group received traditional pain care, including the conventional numerical rating scale (NRS) pain score system, with focus on symptomatic treatment. On this basis, the experimental group managed pain using KABP, including cognitive behavioral intervention, optimization programs, modification of personal beliefs, and behavior patterns. NRS, self-rated anxiety/depression scale (SAS), and quality of life (SF-36) scale were applied at admission, 1 day before surgery, and 3 months after surgery.  Twenty-nine alcohol-dependent male patients with acute traumatic fractures and who received surgical treatment between January 2019 and December 2020 were included in this retrospective case-control study. The age range was 30–65 years (average 50.03 ± 7.94). p < 0.05). There were behaviors promoting health in the experimental group, and five patients expressed abstinence behavior after discharge (p < 0.05).  The perioperative NRS score of the KABP group was lower than that of the control group, and the postoperative anxiety levels improved. Discharge satisfaction was significantly higher than that in the control group ( Patients with alcohol dependence represents a unique set of cases for perioperative pain management. To ensure patient safety, individualized pain management through the application of KABP can significantly reduce postoperative pain and promote the generation of healthy behaviors in patients. Perception and knowledge of pain increased substantially in the past two decades. In August 2002, at the International Pain Society (IASP)'s 10th World Congress on Pain in San Diego, California, USA, a consensus was reached that pain is the fifth vital sign, after blood pressure, body temperature, respiration, and pulse .Significant postoperative pain is often experienced in trauma-related orthopedic surgeries. Patients with alcohol dependence often experience greater pain, compared to the ordinary population , as convInclusion criteria were as follows: (1) patients with alcohol dependence and demonstration of alcoholic withdrawal syndromes; (2) no history of compulsory abstinence therapy prior to admission; (3) no signs of delirium and cognitive impairment. The exclusion criteria were as follows: (1) patients with Alzheimer's disease, disturbance of consciousness, mental illness, and poor cooperation; (2) malignant tumor and severe hepatic and renal failure.P > 0.05), indicating a good comparability  years. Fracture type: six cases of spine burst fracture and 23 cases of limb trauma fracture. Ten patients were treated with conventional nursing (control group), and 19 patients were treated with pain management in the KABP mode . There was no statistically significant difference in baseline data between the two groups  Cognitive intervention: cognitive intervention is an effective measure to improve the quality of pain management and occupies an important position in the perioperative nursing of orthopedic surgery . PreoperCognitive intervention for alcohol withdrawal syndromes: Alcohol withdrawal syndrome mainly includes mental and somatic symptoms. Somatic symptoms generally occur within 7–48 hours after reducing alcohol intake or complete withdrawal, mainly demonstrating symptoms of tremor, sweating, tachycardia, elevated blood pressure, and other aspects, while the threshold of pain is reduced . Psychia(2) Changes in beliefs and attitudes: beliefs come from four factors: knowledge, environment, happenstance, and successful experience . OptimizThe 2012 American Society of Anesthesiologists recommended that multiple modes of analgesia should be used as much as possible [Advanced analgesia: the objective of preventive analgesia is to reduce or eliminate sensitization that is caused by harmful stimuli in the perioperative period. Preventive analgesia can inhibit peripheral and central sensitization, reduce postoperative pain intensity, and reduce the demand for analgesics .Medications: medications that rapidly cross the blood-brain barrier to inhibit central sensitization, including selective COX-2 inhibitors.Individualized analgesia: on-demand symptomatic treatment is transformed into on-time and on-volume analgesia treatment . The tre(3) Behavioral interventions: by increasing the cognitive behavior intervention, an optimized scheme to set up faith to change the behavior of patients was sought . The expOn the premise of alleviating pain in patients, optimization of rehabilitation programs for patients. Functional exercise was performed under pain control, supplemented by dietary education, to improve the comfort of patients and enhance recovery.(1) The NRS digital scoring scale was used to compare the pain scores of patients in the two groups on admission, 1 day before surgery, 1 day after surgery, and 3 months after surgery. (2) SAS anxiety/depression scale was used to compare the anxiety curve of the two groups at admission, 1 day before surgery, and 3 months after surgery. (3) The changes in health behaviors in the two groups were compared using the quality of life scale. (4) Nursing satisfaction was compared between the two groups. When the patients were discharged, a satisfaction questionnaire was issued. It included the following information: satisfaction with the intervention measures, functional exercise guidance, health education, and other contents, with a total score of 100 points, 80–100 points were very satisfied, 60–79 points were satisfied, and <60 points were not satisfied. Overall satisfaction was calculated as follows: (very satisfied + satisfied)/total number of cases × 100%.t-tests; measurement data that did not conform to normal distribution were represented by M , and the rank sum test was used for comparison of groups. Statistical data were expressed as percentages and the χ2 test was used for comparison between groups. Statistical significance was set at p < 0.05.The application of SPSS 23.0, the Shapiro–Wilk method to normality test data, accorded with normal distribution, according to measurement data to mean + SD group comparison between the two independent samples The NRS scoring scale was used at 1 day preoperatively, on the day of operation, 1 day, and 3 months postoperatively to compare between the control group and the experimental group. The results are given in There was no statistically significant difference between the two groups in pain score at admission and 1 day preoperatively. Significant differences were observed on the day of surgery and postoperatively. The NRS pain.Scores were significantly lower than the control group, indicating that the KABP intervention is effective and can significantly reduce the patient's pain.The SAS anxiety/depression scale was used to compare the anxiety curve of the two groups on admission, 1 day before surgery, and 3 months after surgery. The results are given in p < 0.05).No statistical difference in psychological anxiety at admission was observed between the experimental and control groups. The application of cognitive intervention showed that anxiety level was significantly alleviated in the experimental group, compared to the control group 1 day before and 3 months after surgery  was used at admission and 3 months after surgery to compare the differences in quality of life between the two groups. The results are given in Tables p < 0.05). No significant decrease in SF-36 scores was observed in the experimental group (p < 0.05). In addition, in this study, there were five patients in the experimental group who took the initiative to express abstinence determination and/or action.The results showed that the scores of the two groups at admission were not statistically significant. However, due to fracture trauma, the quality of the patients' life in both groups decreased to varying degrees within three months of surgery. Comparatively speaking, the scores of the control group were lower, and the results were statistically significant. In comparison within the same group, the quality of life of the control group was significantly reduced, and the results were significant (Comparison of nursing satisfaction between the two groups is given in p < 0.05).The satisfaction of the experimental group was significantly higher than that of the control group, and the results were statistically significant , whereas their general intelligence and familiar knowledge are relatively intact . In thisMultidirectional communication is conducive to patients' understanding of knowledge and mastery of exercise methods. Under the encouragement and guidance of medical staff, it is easier to transform knowledge, methods, and beliefs into healthy behaviors. In this study, the change in patient anxiety, improvement of their sense of participation, and the degree of treatment cooperation indicate that the health education in the KABP mode make patients more receptive. According to the SF-36 health status scores, the quality of life in the experimental group did not significantly decrease three months after surgery, whereas the quality of life in the control group significantly decreased. In the later investigation, five patients in the experimental group took the initiative to express the willingness or action of abstaining from alcohol, reflecting the intervention's positive effect and promoting the establishment of patients' healthy behaviors.In this study, 30% of patients in the control group and 84.2% in the experimental group were highly satisfied. The education in the KABP mode takes the needs of patients as the starting point, attaches importance to communication and interaction with patients in the intervention process to significantly improve the degree of attention they feel, and increases patients' satisfaction with nursing work.In conclusion, on the basis of ensuring safety, individualized pain management programs can significantly reduce patients' pain and promote the generation of healthy behaviors through the application of knowledge, belief, and action mode . This st


Pain is a common complication after mixed hemorrhoids, which seriously affects the recovery of patients and prolongs the length of hospital stay. Acupoint catgut embedding has advantages in improving a variety of acute and chronic pain diseases, but there is still a lack of rigorous randomized controlled studies to verify its efficacy and safety in the treatment of postoperative pain of mixed hemorrhoids. Therefore, the purpose of this randomized controlled trial is to evaluate the clinical efficacy of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids.This is a prospective randomized controlled trial to study the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids. Approved by the clinical research ethics committee of our hospital, the patients were randomly divided into observation group and control group according to 1:1. The observation group received acupoint catgut embedding before the operation, while the control group received no special treatment. The efficacy and safety indexes were concerned after the operation, and the observation indexes included: resting state and visual analogue scale (VAS) score during defecation, postoperative hospitalization time, total amount of analgesic use, adverse reactions, etc. Finally, we carried on the data statistical analysis through the SPSS version 19.0.This study will evaluate the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids, and the results of this study will provide a new idea for the selection of postoperative analgesia for mixed hemorrhoids resection.OSF Registration number: DOI 10.17605/OSF.IO/T2ZGY. The treatment of hemorrhoids depends on the symptoms and stages of the disease. Hemorrhoidectomy is considered to be an effective method for the treatment of III-IV degree symptomatic hemorrhoids. Open hemorrhoidectomy is still the most common surgery for hemorrhoids, despite the emergence of many surgical methods. Pain is a common complication after hemorrhoidectomy, with moderate and severe pain accounting for 65% of the total number of patients, affecting patients’ recovery and prolonging hospital stay.Hemorrhoids is one of the most common diseases in anorectal diseases, which can occur at any age.,8 Some other methods have been also used to reduce postoperative pain, such as COX-2-specific inhibitors, botulinum toxin, and calcium channel blockers, etc.,,10 but there are side effects or there is no conclusive evidence to prove their efficacy.,11 Therefore, it is necessary to continue to explore safe and effective solutions to the problem of postoperative pain in patients with hemorrhoidectomy.Opioid painkillers and non-steroidal anti-inflammatory drugs are commonly used to relieve pain, but their action time is short and have side effects.–14 with the characteristics of certain curative effect, low cost and low adverse reactions. Now there is evidence that electroacupuncture combined with acupoint catgut embedding can effectively improve postoperative pain of mixed hemorrhoids and reduce the use of analgesics. However, there is a lack of a single randomized controlled study on acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids. Therefore, this randomized controlled trial is intended to evaluate the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids.Acupoint catgut embedding is a traditional external therapy in China, which is an extension and development of acupuncture and moxibustion therapy. Under the guidance of meridian theory, catgut or absorbable surgical thread is implanted into the corresponding acupoints, and the decomposition and absorption process produces a lasting, slow and stable acupuncture effect at the acupoints. At present, it has been widely used in the treatment of acute and chronic pain such as migraine, sciatica and low back pain,22.1 and the flow chart is shown in Figure This is a prospective, single-blind, randomized controlled trial to investigate the efficacy and safety of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids. This trial will follow the comprehensive trial reporting criteria,2.2This study protocol was in accordance with the Helsinki Declaration and approved by the Clinical Research Ethics Committee of our hospital. This experiment has been registered at open science framework (registration number: DOI 10.17605/OSF.IO/T2ZGY). Prior to randomization, all patients were required to sign a written informed consent form. Participants could withdraw from the study at any time for any reason, and patients’ consent would be required for their data to be used after the withdrawal.2.3Clinical Guidelines for Diagnosis and Treatment of Hemorrhoids (2006) formulated by Colorectal and Anorectal Surgery Group of Chinese Medical Association, etc.); ②Aging 18 to 65 years old; ③With no previous hemorrhoid surgery history, and the shape and function of the anus was completely normal; ④Patients with voluntary test, signed informed consent and having a good compliance.Inclusion criteria: ① In accordance with the diagnosis of mixed hemorrhoids, and belong to stage III and stage VI  point and Changqiang (DU1) point area, we used lumbar puncture needle cannula 26 milli-needle, put 1 cm of catgut in the front end, inserted the needle core from the tail end, punctured the acupoint to get qi, slowly pushed into the needle core, and withdrew from the needle tube, and kept the catgut in the acupoint. The mixed hemorrhoidectomy was carried out after embedding the thread.In the control group, mixed hemorrhoidectomy was performed directly after anesthesia took effect.Both groups of patients were treated with the same postoperative nursing plan. When the pain was unbearable, they were given Nimesulide dispersible tablet 0.1 g orally , and the usage was recorded.2.71. (VAS), which is commonly used to measure pain intensity, would be used to evaluate changes in patient pain. Patients would be asked to mark a point between 0 and 100, where 100 means the most pain (the far right) and 0 means no pain (the far left). VAS scores at resting state were recorded at 4 hours, 12 hours, 24 hours, and 48 hours after surgery. VAS scores during defecation were recorded on postoperative day 1, day 2, day 3, and day 7.Primary outcome measures: the visual analogue scale2.Secondary outcomes: ① total amount (tablets) of Nimesulide dispersible tablets taken orally by the patient within 7 days after surgery; ②patients’ stay in hospital after operation (defined as the day from the start of operation to discharge); ③adverse reactions: patients in both groups experienced discomfort  during treatment.2.8All research data would be collected and collated by 1 to 2 research assistants and recorded in pre-designed tables. The study materials would be kept in a separate storage room to protect confidentiality before, during and after the study. Access to the database was limited to researchers in the research group.2.9t test was used, the counting data was expressed as rate (%), and the χ2 test was applied. When P < .05, the difference was statistically significant.SPSS19.0 statistical software was used to process the data, the measurement data were expressed as mean ± standard deviation ( ± S), the 3 The degree of pain is affected by many factors, including surgical methods, defecation, spasm of anal sphincter, perianal inflammation, etc.,20 The pain may persist throughout the whole treatment, and the wound pain during dressing change increases the patient's fear. Some patients even dare not defecate because of fear of pain, causing constipation, causing a lot of trouble.The inner wall of the anal canal is one of the most innervated tissues in the digestive tract, so the occurrence of pain after hemorrhoidectomy is a predictable outcome. Modern studies have confirmed that it has the following functions:–24① Adjusting immune function: the absorbable line implanted into the acupoints by thread embedment therapy is a foreign protein for the body, which can stimulate the body to produce allergic reactions, produce lymphatic factors, improve the phagocytic function of macrophages, so as to enhance the immune function of the body; ② Enhance the ability of stress: the stimulation of the absorbable line embedded in the acupoints on the body can improve the stress ability of the body, promote local vasodilation and increase neovascularization beds, increase blood flow, improve local lymphatic and blood circulation, accelerate the metabolism of tissue, thus reducing exudative adhesions and accelerating absorption of inflammation; ③ Promote the generation of neuropeptide substances: acupoint catgut embedding can stimulate the central nervous system to produce nerve impulse, promote the secretion and synthesis of endogenous opioid substances such as endorphins, improve the pain threshold, and block the feedback loop of pain signals by inhibiting the release of inflammatory factors such as nitric oxide, so as to achieve the effect of pain relief. At present, acupoint catgut embedding has been applied to a variety of pain diseases, and its efficacy and safety have been confirmed. We intend to explore the efficacy of acupoint catgut embedding in the treatment of postoperative pain of mixed hemorrhoids through this randomized controlled study, and the results of this study will provide a new idea for the selection of postoperative analgesia after mixed hemorrhoidectomy.Acupoint catgut embedding is a compound treatment method integrating multiple effects, such as acupoint sealing effect, acupuncture effect, pricking blood effect and embedding needle effect, with distinct characteristics of traditional Chinese medicine.This study also has some limitations: due to the short observation period in this study, we cannot understand the impact of long-term efficacy, so we may increase the follow-up time if necessary; due to the particularity of the intervention measures, this study could not achieve double blindness, which may have some impact on the results.Conceptualization: Xiaorui Pei, Haotian Li.Data curation: Xiaorui Pei, Shijun Song.Formal analysis: Shijun Song, Haotian Li.Funding acquisition: Debao Lu.Software: Haotian Li, Debao Lu.Supervision: Haotian Li.Writing – original draft: Xiaorui Pei, Shijun Song.Writing – review & editing: Xiaorui Pei, Shijun Song.