Bariatric surgery depends on the development of novel anesthetic techniques to reduce the incidence of complications and improve postoperative outcomes. Ketamine and dexmedetomidine have been used for perioperative analgesia and we hypothesized that they would decrease postoperative morphine requirements. The objective of this trial is to study whether choice of ketamine or dexmedetomidine infusion would affect postoperative total morphine consumption.Ninety patients were equally randomized into three groups. The ketamine group received a bolus dose (0.3 mg/kg) of ketamine over 10 min, followed by an infusion of the same drug (0.3 mg/kg/h). The dexmedetomidine group received a bolus dose (0.5 mcg/kg) of dexmedetomidine over 10 min, followed by an infusion of this drug (0.5 mg/kg/h). The control group received a saline infusion. All infusions were given till 10 min before the end of surgeries. Intraoperative fentanyl was given when patient developed hypertension and tachycardia despite adequate anesthesia and muscle relaxation. Postoperative pain was managed by a rescue dose of 4 mg of IV morphine, with a minimum interval of 6 h between morphine doses if the numerical rating scale (NRS) score was ≥ 4. The primary outcome was the total morphine dose, and the secondary outcomes were intraoperative fentanyl requirement, time to extubation, postoperative nausea and vomiting (PONV), NRS scores, and modified observer’s agitation/sedation scale (MOASS) scores.Compared with ketamine, dexmedetomidine decreased the need for fentanyl intraoperatively (160 ± 42 µg), shortened the time to extubation (3 ± 1 min), and improved MOASS and PONV scores. In turn, ketamine decreased postoperative NRS scores and the need for morphine (3 ± 3 mg).Dexmedetomidine treatment was associated with lower fentanyl doses, a shorter time to extubation, and better MOASS and PONV scores. Ketamine treatment was associated with significantly lower NRS scores and morphine doses. These results indicated that dexmedetomidine effectively decreased intraoperative fentanyl requirement and the time to extubation, while ketamine decreased the need for morphine.This trail was registered on the clinicaltrials.gov registry (NCT04576975) on October 6, 2020.The online version contains supplementary material available at 10.1186/s12871-023-02059-3. Surgical interventions aimed towards treating obesity are known as bariatric surgeries. There has been a drastic increase in the use of bariatric surgery for patients with medically complicated obesity who have difficulty losing weight by other methods .Advances in anesthetic techniques have improved surgical procedures and clinical outcomes . HoweverJudicious use of anesthetics is necessary because these drugs increase the risk of complications. Conversely, decreased use of opiates may result in postoperative pain, slowing postoperative recovery . TherefoKetamine is an N-methyl-D-aspartate antagonist with analgesic and anti-hyperalgesic properties at low doses . Ketamin2 adrenoceptor agonist used as an adjuvant analgesic in the perioperative period ). Patients were randomly divided into the following three groups:Ketamine group received a bolus dose of ketamine   diluted with 0.9% normal saline (NS) and infused over a 10-min period using a 20-mL syringe before induction, followed by an infusion of ketamine  at a rate of 0.3 mg/kg/h until 10 min before the end of the surgery.Dexmedetomidine group received a bolus dose of dexmedetomidine  (0.5 µg/kg IBW) diluted with 0.9% NS and infused over a 10-min period using a 20-mL syringe before induction, followed by an infusion of dexmedetomidine  at a rate of 0.5 µg/kg/h until 10 min before the end of the surgery.Control group received a bolus dose of 0.9% NS over a 10-min period using a 20-mL syringe infused before induction, followed by an infusion of 0.9% NS (50 mL in a 50-cc syringe).2: 35–40 mmHg). Intraoperative vital data were recorded every 5 min.General anesthesia was induced with intravenous lidocaine (0.5 mg/kg IBW), propofol (1.5 mg/kg LBW), fentanyl (1.0 µg/kg TBW), and rocuronium (1.1 mg/kg IBW) for rapid-sequence endotracheal intubation. There were no cases of failed intubation in our cohort. Rocuronium was given every 30 min, and its effect was assessed by neuromuscular blockade monitoring keeping the train-of-four ratio between 0 and 1. General anesthesia was maintained with sevoflurane in an oxygen and air mixture guided by a bispectral index score between 40 and 60. Patients were mechanically ventilated with the maintenance of normocapnia  occurred, a crystalloid fluid incremental bolus (20 mL/kg IBW over 20 min) was administered, and then ephedrine was administered in 6-mg increments. For bradycardia (defined as a heart rate [HR] below 60 mmHg for ≥ 1 min), atropine 0.5 mg was administered as determined by the anesthesiologist.Intraoperative pain was defined as the development of HTN and tachycardia despite adequate anesthesia and muscle relaxation. HTN was defined as an MAP of > 20% of baseline on two consecutive readings within 5 min. Tachycardia was defined as an HR of > 20% of baseline for 5 min. A rescue dose of fentanyl was administered in increments of 0.5 µg/kg TBW. The intraoperative total fentanyl dose for each patient was calculated.Upon awakening, the patient received sugammadex (2 mg/kg) with a repeated dose of 4 mg/kg after 5 min if needed for muscle relaxation. A record of “time to extubation,” which was defined as the time taken for tracheal extubation after the discontinuation of anesthesia, was made for every patient.All patients were monitored postoperatively in the post-anesthesia care unit and ward. Sedation was assessed using the modified observer’s assessment of alertness/sedation scale (MOASS) Table . Scores Postoperative pain was assessed using the numerical rating scale (NRS), with scores varying from 0 (no pain) to 10 (worst pain). The patients were informed preoperatively about the use and values of the NRS. The NRS score was recorded at 0, 30, and 60 min and 2, 6, 12, and 24 h after surgery.All patients received 1 gm of IV paracetamol  every 6 h for 24 h postoperatively. In addition, a rescue dose of 4 mg of IV morphine with a minimum 6-h interval was administered between doses if the NRS score was ≥ 4, if needed. The total doses of morphine were calculated.All patients were assessed for PONV using the PONV intensity scale Table . AssessmPostoperative complications  were recorded.Data were coded, tabulated, and analyzed using SPSS software version 16.0  for Windows. Continuous variables were presented as mean (standard deviation) or median (Q3-Q1) and were compared using one-way analysis of variance or the Kruskal-Wallis test. Categorical variables were presented as frequency (%) and were compared using the chi-square test. Multiple pairwise comparisons were performed using the Tukey honestly significant difference test, Mann–Whitney test, or chi-square test. A P-value of less than 0.05 was considered statistically significant, and Bonferroni correction was applied when necessary.The primary outcome was the need for analgesics postoperatively in the form of total morphine consumption. The secondary outcomes were the need for analgesics intraoperatively, time to extubation, postoperative sedation scores, NRS scores, and PONV scores.A total of 100 patients were assessed for eligibility between April 2021 and November 2021. Ninety patients were enrolled in the study (30 in each group). Ten patients were excluded because of refusal to participate (four cases), a history of psychiatric disorders (three cases), and uncontrolled medical conditions (DM [two cases] and HTN [one case]) . Further, the need for morphine was marginally lower in the dexmedetomidine group than in control group; however, the benefits of reduced postoperative morphine requirement cannot be ignored. Similar to our results, Mehta et al. found that ketamine infusion decreased postoperative analgesic requirements compared with a control in patients undergoing laparoscopic bariatric surgery .2c and α2a receptors located in the dorsal horn by inhibiting the pro-nociceptive transmitters, primarily substance P and glutamate, and the hyperpolarization of the spinal interneurons [In terms of postoperative pain control, ketamine can also help reduce the development of chronic post-operative pain, in addition to its opioid-relieving effect. This can be achieved through the inhibition of the receptors of the N-methyl-D-aspartate and by reduction of wind-up and central sensitization . The anarneurons .Our results demonstrated that dexmedetomidine infusion reduced PONV scores, suggesting that this drug had an anti-emetic effect during the postoperative course. Hussein and Mostafa showed that dexmedetomidine reduced PONV in patients undergoing bariatric surgery compared with controls . In addiFor these reasons, we suggest that ketamine or dexmedetomidine should be considered as part of multidisciplinary therapy for all patients with chronic diseases or with chronic pain syndromes undergoing painful surgeries. Future long-term studies are essential to address the issue of prevention of postoperative chronic pain syndromes. Additionally, we suggest that the effects of ketamine and dexmedetomidine in patients that are at high risk for developing acute postoperative morphine-resistant pain  should be investigated. Combined effect of both drugs is a point of future study.Confounding factors that might affect the need for analgesia, such as depression and pre-existing pain, were not assessed preoperatively. Thus, a long-term assessment of the effect of these factors on postoperative pain is needed. The lack of long term assessment of pain scores is also a limitation of our study.Ketamine and dexmedetomidine can effectively manage pain in patients with MO undergoing bariatric surgery. Dexmedetomidine improves clinical outcomes in the intraoperative period, while ketamine improves analgesia in the postoperative period. In addition, dexmedetomidine may improve postoperative recovery in terms of sedation and PONV.Below is the link to the electronic supplementary material.Supplementary Material 1


Acute myocardial infarction (AMI) is the leading life-threatening disease in the emergency department (ED), so rapid chest pain triage is important. This study aimed to establish a clinical prediction model for the risk stratification of acute chest pain patients based on the Point-of-care (POC) cardiac troponin (cTn) level and other clinical variables.post-hoc analysis of the database from 6,019 consecutive patients  attending a local chest pain center (CPC) in China between October 2016 and January 2019. The plasma concentration of cardiac troponin I (cTnI) was measured using a POC cTnI  assay. All the eligible patients were randomly divided into training and validation cohorts by a 7:3 ratio. We performed multivariable logistic regression to select variables and build a nomogram based on the significant predictive factors. We evaluated the model's generalization ability of diagnostic accuracy in the validation cohort.We conducted a We analyzed data from 5,397 patients that were included in this research. The median turnaround time (TAT) of POC cTnI was 16 min. The model was constructed with 6 variables: ECG ischemia, POC cTnI level, hypotension, chest pain symptom, Killip class, and sex. The area under the ROC curve (AUC) in the training and validation cohorts was 0.924 and 0.894, respectively. The diagnostic performance was superior to the GRACE score (AUC: 0.737).A practical predictive model was created and could be used for rapid and effective triage of acute chest pain patients in the CPC. Acute myocardial infarction (AMI) is a very common cause of hospital admission in the emergency department (ED) and causes heavy healthcare burdens . AMI is Point-of-care (POC) cardiac troponin (cTn) is widely used and plays a critical role in chest pain centers. Although high-sensitive cardiac troponin (hs-cTn) in the central laboratory could provide better diagnostic accuracy, it requires a longer turnaround time (TAT) of approximately 1 h in most hospitals , 7. The The POC cTnI assay is routinely used in the chest pain center (CPC), which is a regional chest pain center unit intended to get faster and standardized management of suspected ACS patients in the emergency department. Chest pain patients in the emergency department will undergo a preliminary screening according to medical history, risk factors, symptoms, and physical examination, and only approximately 5% of patients who are suspected high risk  are admitted to the CPC for further triage. Moreover, the chest pain center is not limited to China but is an important organization worldwide such as in the United States , GermanyIn this study, we have established a simple risk stratification model through retrospective analysis of the clinical data of a large-scale population in CPC, which could be used for rapid and effective triage of acute chest pain patients.This is a retrospective study. Between 1 October 2016 and 31 January 2019, all patients attending the CPC of TEDA International Cardiovascular Hospital were included in this study. Patients with high-risk chest pain  in the emergency department attended the CPC. Inclusion criteria were as follows: acute chest pain (onset time <24 h) patients attending the emergency department or suspected high-risk chest pain patients transferred from other hospitals in surrounding cities and regions. Exclusion criteria were as follows: Prehospital-diagnosed non-cardiac chest pain (NCCP) patients. Because of the large number of chest pain patients in our center every day (more than 100 people per day), to reduce the queuing time and to leave time for emergency care of fatal chest pain patients, prehospital triage was performed by the attending clinician in the emergency department according to symptoms and medical history, and NCCP patients didn't attend the CPC. Most patients can be diagnosed with non-cardiogenic chest pain by simple physical examination and consultation, such as herpes zoster caused by skin surface herpes. There are fixed tender points in the costal cartilage of patients with costochondritis. In patients with chest pain caused by pneumothorax, unilateral lung breathing sound is weakened or disappeared; in patients with transient pain sites, pinprick pain lasting 1–2 s at a time is usually a disorder of vegetative nerve function.All patients were randomly divided into the training and validation by a ratio of 7:3 using random sampling. The data were exported from the database of the CPC server. This is a regional chest pain center unit in Tianjin Economic-Technological Development Area.Electrocardiogram (ECG) was requested immediately on arrival at the CPC. Patients with suspected ACS arrived at the CPC in three ways: (a) by ambulance from any of the 72 local hospitals, (b) called for an ambulance from home, or (c) came to the hospital by themselves. The diagnosis of AMI was made by clinicians with at least one of the following: (a) Coronary arteriography (CAG) indicating a flow-limiting dysfunction such as coronary dissection, thrombotic occlusion of the epicardial artery, disruption of collateral flow, or distal embolization. (b) For patients that did not undergo CAG, checking for ischemic symptoms and typical ECG changes of STEMI or abnormal Q waves, or serial changes in high-sensitive (hs)-cTnI/T levels and echocardiography/computed tomography (CT)-based coronary angiography showing myocardial infarction (MI) .r2 > 0.99; (2) repeatability: coefficient of variation (CV) %<15%; (3) limit of detection (LoD) <0.05 ng/ml; (4) normal range: using 95% confidence intervals, POC cTnl reference values in the normal population were less than <0.4 ng/ml.EDTA anticoagulant whole blood samples were collected immediately on arrival at the CPC, and the POC cTnI was measured with a Triage cardiopulmonary Function Test Kit panel  on the Biosite Triage® Meter Plus System . The test panel contains five assay items using fluorescence immunoassay, including B-type natriuretic peptide (BNP), troponin I, creatine kinase (CK), creatine kinase-MB (CK-MB), and myoglobin, and the result is available within 15 min. According to the manufacturer's instructions, the analytical characteristics of cTnI using the kit were as follows: (1) linear range: 0.05–30 ng/ml, EDTA anticoagulant whole plasma samples  were used for highly sensitive troponin assay using the access hsTnI kit  on the Unicel DxI 800 immunoassay analyzer . The guidelines of the International Federation of Clinical Chemistry (IFCC) have recommended the analytical performance standard of high-sensitivity cardiac troponin assays –21. The χ2 test. Normality was determined using the Shapiro–Wilk test and all variables analyzed were not normally distributed. Descriptive statistics for continuous variables which were not normally distributed were reported as quartiles (Q1 and Q3) and compared between the training and validation set with the Mann–Whitney test. To select variables for the prediction model, logistic regression was performed, and variables that were statistically significant in univariate analysis were chosen to construct the multivariate model. The following statistical analysis and plotting were conducted with the R software (version 4.0.2). To visualize the expression and diagnostic value of cTnI, the violin plot and ROC curve were plotted with the ggplot2 package (v3.3.2) and pROC package (v1.16.2), respectively. To construct the prediction model, we used the glmnet package (v4.0.2) in the binomial model with the selected variables in the multivariate analysis. The glmnet package default uses the least absolute shrinkage and selection operator (LASSO) analysis in a penalized logistic regression model . Categorical variables were reported as counts and percentages and were analyzed with one-way Pearson's on model . We perfWe collected data from 6,019 consecutive patients in the study. After excluding patients with missing data, 5,397 patients were included in the final analysis. Included patients were randomly divided into training and validation cohorts by a ratio of 7:3 . The popThe cTnI levels of each group are shown using a violin plot in Logistic regression analysis identified factors significantly associated with AMI, including ECG ischemia, cTnI, chest pain symptoms, Killip class, hypotension, and sex . Then weTo investigate if the nomogram adds value over and beyond existing clinical strategies for risk stratification of chest pain, we compared it with hs-cTnI and the Global Registry of Acute Coronary Events (GRACE) score. The hs-cTnI level is shown in In the study, we constructed a clinical prediction model for rapid AMI diagnosis using the data from a population of 5,397 chest pain patients. The early AMI diagnosis has an important clinical significance which may reduce the rate of mortality and comorbidity and reduce unnecessary medical costs. The T-MACS decision rule is a common clinical prediction model for ACS , 26, 27 We have identified several variables other than troponins, such as ECG and hypotension. ECG has an important role in AMI diagnosis, especially sensitivity in STEMI, which is an important supplement for troponin. We found that men have a higher AMI risk , which iThe early diagnosis leads to an early clinical decision, most (95.3%) of AMI patients could be diagnosed at the initial time . Early AThe sensitivity of the POC cTnI assay is low. To improve the sensitivity without increasing the TAT, we think a more sensitive POC cTn assay is warranted in the CPC. In this study, a triage product was used, which was a common assay used in many studies , 41. A hThe prevalence of AMI in this study was 72.7%, which is much higher than in similar studies. Aldous  reportedThe study has several limitations. This is a retrospective study, and we analyzed several known risk factors of AMI, which are routinely documented in the CPC. We did not compare with some other known models such as the TIMI and heart scores as we could not get complete data for these analyses.A practical predictive model was created and could be used for rapid and effective triage of acute chest pain patients in the CPC.


Opioids are commonly prescribed for postoperative pain, but may lead to prolonged use and addiction. Diabetes impairs nerve function, complicates pain management, and makes opioid prescribing particularly challenging.This retrospective observational study included a cohort of postoperative patients from a multisite academic health system to assess the relationship between diabetes, pain, and prolonged opioid use (POU), 2008–2019. POU was defined as a new opioid prescription 3–6 months after discharge. The odds that a patient had POU was assessed using multivariate logistic regression controlling for patient factors .A total of 43,654 patients were included, 12.4% with diabetes. Patients with diabetes had higher preoperative pain scores  and lower opioid naïve rates . Following surgery, patients with diabetes had higher rates of POU  despite receiving similar opioid prescriptions at discharge. Patients with Type I diabetes were more likely to have POU compared to other patients .In conclusion, surgical patients with diabetes are at increased risk for POU even after controlling for likely covariates, yet they receive similar postoperative opiate therapy. The results suggest a more tailored approach to diabetic postoperative pain management is warranted. In the last decade, precision medicine has promised to revolutionize healthcare by allowing medical therapies to be tailored to the unique needs of each individual patient . PrecisiPatients with diabetes are a unique population for which there is opportunity for precision prescribing. Diabetes changes nociceptive physiology resulting in increased hypersensitivity to pain and a weaker response to morphine,  particulIn this study, we sought to quantify postoperative opioid prescribing and prolonged opioid prescriptions among diabetic patients as compared to other unique patient populations from a diverse healthcare center. The hypothesis was that prescription opioid strength, as measured by daily morphine milligram equivalents (MME), would not differ for patients with diabetes compared to non-diabetics. This work provides population-level evidence on current opioid prescribing practices at an academic institute and associated patient outcomes that can be used to guide new policies and precision medicine initiatives.In this retrospective, observational study, Electronic Health Records (EHR) were used to identify adult surgical patients at a diverse health care center, which included an academic medical center, a community hospital, and primary and specialty care alliance,  between Current Procedural Terminology (CPT) codes, International Classification of Diseases, 9th and 10th Revision, Clinical Modification  codes, and Procedures Coding Systems (ICD10PCS) codes were used to catch patients who underwent a surgery. The Clinical Classifications Software for Services and Procedures (CCS-SP) was then used to categorize surgeries into 19 classes, which can be seen in Participants included adults aged between 18 and 89 who underwent surgery at one of the healthcare facilities and were prescribed an opioid for postoperative pain management. The index date chosen for patients with records of multiple surgeries was the date of their first ever surgery. The list of opioids considered is given in Patients were excluded if their inpatient stay was greater than 13 days. This decreased inclusion of patients who had complications following surgery reducing heterogeneity of the patients’ postoperative course. Similarly, to properly study patient relationship to opioids after surgery, we excluded all patients who faced an external event or competing risk which might have forced them to take opioids independently of their postoperative pain management. Namely, we excluded patients who died or had another surgery less than 6 months after discharge of their first surgery. In addition, patient were excluded if they did not receive at least one opioid prescription following surgery (<3%). Finally, some patients only are seen once for a one-off surgery making studying their postoperative pain course impossible. Thus, we excluded patient with minimal follow up. The minimum numbers of encounters required on the different time windows before and after surgery is given in the flow chart  and was Patient variables included Gender, Race/ethnicity , age at surgery, insurance type , Charlson Comorbidity Index, and body mass index (BMI). We additionally included the number of tobacco packs smoked per day and volume of alcohol consumed per week as declared by the patient at the preoperative visit, and the preoperative pain score. Comorbidities were identified using ICD codes based on Clinical Classification Software . ObesityAmerican Society of Anesthesiologists (ASA) physical status at the preoperative visit and the length of stay [Patient were stratified by documentation of diabetes any time before surgery using ICD-9 or ICD-10 codes. Patients were further stratified by Type I Diabetes (DM1) and Type II Diabetes (DM2). Clinical variables included the surgery category, as given by the CCS-SP codes,  anesthes of stay .Unified Medical Language system  are used in the literature . Based oBivariate associations were measured using a Fisher’s exact test for categorical covariates, and using a one-way ANOVA for continuous covariates. Unadjusted odd ratio entailed by each variable against the outcome were computed with Fischer’s exact statistic, and a logistic regression was fitted with all study variables against the outcome to get adjusted odd-ratios that eliminate the confounding effects between covariates. All statistical tests were two-sided, and the null hypothesis was rejected if computed p-value was under the threshold of 0.05.Many different definitions for POU were compared, based on available definitions in a recent systematic review . Based oIn the cohort of 43,654 surgical patients, a total of 5,417  patients with diabetes were identified . DiabetiPatients were further stratified by Type I Diabetes (DM1) and Type II Diabetes (DM2) . DM1 patPredictors of POU are presented in Optimal postoperative pain management for patients with diabetes remains unclear. In this study of real-world care, we found uniform postoperative opioid prescribing regardless of diabetes diagnosis. Specifically, in this large multiethnic population there was no difference in discharge opioid MMEs between patients with and without diabetes even though diabetic patients presented with known pain risk factors, including higher rates of previous opioid use, depression, and preoperative pain scores. Following surgery patients with diabetes had higher rates of POU compared to non-diabetic patients. Diabetic patients have unique physiology and heightened pain, which argues the need for more tailored postoperative pain management. This study provides considerations for postoperative opioid prescribing to patients with diabetes using real world data.People with diabetes have several physiologic changes that make pain management more complex. Multimodal analgesia combines analgesic medications and techniques  targeting different pain mechanisms with the goal of synergistic pain relief. With concurrent use of non-opioid pain medications such as acetaminophen,  non-sterPreoperative opioid use is one of the most significant determinants of POU. In this study, patients with diabetes had a higher incidence of preoperative opioid use. However, our study adds that even after accounting for preoperative opioid use, DMI or DMII is an independent risk factor for POU. These findings, if confirmed in other data, provide several next steps. For example, we found providers generally are not accounting for individual risk factors with postoperative opioid prescribing; with every patient prescribed uniform doses. Furthermore, within this academic setting, opioid rates have remained fairly constant over this time period, as we have previously shown . Given tThere were also important differences in opioid-related outcomes between DMI and DMII surgical patients. While in general diabetic patients had higher rates of POU, DMI patients had significantly higher POU rates compared to DMII patients, yet again there was no difference in the quantity of MMEs received at discharge. Specifically, we found DMII patients had a 2-fold increased risk for obtaining a new opioid prescription 3 to 6 months after surgery. This was a surprising finding and highlights the need for closer monitoring of DMII patients following surgery. The literature is clear that pain is a common adverse outcome of diabetes. But most of this evidence has not compared the pain experience between DMI and DMII. However, there is some animal evidence that the nociceptive pathways in DMI and DMII differ . This fiBoth DM1 and DMII patients are characterized by chronic elevations of blood glucose, and the microvascular sequelae associated with this including impaired wound healing, neuropathy retinopathy, and nephropathy. However, DMI is typically acquired early in life while DMII is a disease of the aging adult. We hypothesize that the increased rate of POU among those with DMI may reflect the more prolonged exposure to the metabolic disturbance in these patients, analogous to renal and ocular damage that is more common in DMI compared to DM2 after controlling for age , 34. FutPrior research reported diabetes as a risk factor for POU , 36–40. This study has limitations. The Northern California-based cohort was multisite and diverse but may not be generalizable across the United States diabetic population. However, compared to the US statistics,  the raciIn conclusion, in a multiethnic cohort of diabetic surgical patients, nearly 20% requested an additional opioid prescription three months after surgery. After controlling for important covariates, patients with DMI had over a two-fold risk of POU. In addition, our findings highlight a lack of tailored opioid prescribing for this vulnerable population. These finding present evidence that may guide opioid prescribing among diabetic surgical patients to improve patient outcomes in vulnerable populations.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.S3 Table(DOCX)Click here for additional data file.S4 Table(DOCX)Click here for additional data file.S5 Table(DOCX)Click here for additional data file.S1 Fig(PDF)Click here for additional data file.S1 Checklist(DOCX)Click here for additional data file.


The multivariate analysis did not reveal any confounding factors, showing that only the pharmaceutical intervention could explain this result. This study demonstrates a positive impact of pharmacist consultations on postoperative pain in ambulatory surgery.Post-operative pain is a common symptom of ambulatory surgery. The objective of this study was to evaluate a pain management protocol integrating a pharmacist consultation. We conducted a quasi-experimental, single center, before-after study. The control group was recruited between 1 March and 31 May 2018 and the intervention group between 1 March and 31 May 2019. Outpatients in the intervention group received a pharmacist consultation, in addition to the usual anesthesiologist and nurse consultations. Pharmacist consultations were conducted in two steps: the first step consisted of general open-ended questions and the second step of a specific and individualized pharmaceutical interview. A total of 125 outpatients were included in each group. There were 17% (95% CI 5 to 27%,  Pain at home is a frequent symptom of ambulatory surgery . Acute pPharmacists could have an impact on the prevention of postoperative pain . AccordiIn this context, the involvement of a clinical pharmacist in the management of acute postoperative pain in ambulatory surgery seems to be relevant. However, at the present time, no study has been carried out.The objective of this study was to evaluate a pain management protocol integrating a pharmacist consultation.The main hypothesis is that adding a pharmacist to the pain management protocol would lower the proportion of outpatients experiencing moderate to severe pain. The secondary hypothesis is that this protocol could improve the overall satisfaction regarding outpatient care.This study (E 2020-87) was approved by the Institutional Review Board (IRB) of a University Hospital in France. Written patient consent was waived by the IRB.We conducted a quasi-experimental, single-center, before-after study. This manuscript complies with the applicable TREND  guidelines .®, patient files, and Gesbloc®, operating room timetable) and outpatients in the intervention group were prospectively included between 1 March and 31 May 2019 by the clinical pharmacist (EB) and two nurse anesthetists.Two groups of outpatients were compared: a control group and an intervention group. Outpatients in the control group were retrospectively included between 1 March and 31 May 2018 from the electronic health records , odontologic, maxillofacial and ear, nose, and throat (MF/ENT), digestive and visceral, gynecologic, ophthalmologic, plastic and vascular ambulatory surgeries. In the intervention group, outpatients had to have a pharmacist intervention to be included. Exclusion criteria were outpatients who had an ASA (American Society of Anesthesiologists) score ≥3, chronic pain or long-term analgesic treatment, a psychiatric disorder and advanced cognitive impairment, pregnancy, a contraindication to ambulatory surgery, lack of French language proficiency, conversion to conventional hospitalization, a surgical or anesthesia-related complication. Outpatients operated on by surgeons who practiced in 2018 but not in 2019 were not included. Finally, in accordance with the regulations, the outpatients placed under legal protection, guardianship, or curatorship were excluded.The selection of patients for the control group was carried out retrospectively in the year preceding that of our study. The selection period was identical (year n − 1) to that of the intervention group in order to avoid a seasonal bias. In practice, we identified patients who had an ambulatory surgical procedure between 1 March and 31 May 2018. We applied the inclusion criteria in chronological order and the exclusion criteria patient by patient until the 125 patients were grouped together.-Several weeks before surgery, the date of surgery was scheduled with the surgeon.-○The anesthesiologist explained to the patient the type of anesthesia, the type of surgery, the pre-operative preparation , ongoing chronic treatment (in particular anticoagulant and antiplatelet medications), and the analgesic treatment. At the end of this consultation, the patient was prescribed their postoperative analgesic treatment so that they could have them at home before the ambulatory surgery.○The nurse anesthetist reminded the patient of all the logistical modalities inherent to the ambulatory surgery: the time at which they had to stop eating, the rules of hygiene including when and how to take a shower, when and how to organize transport to the hospital, and how to take the chronic treatment in the morning, etc.Several days before surgery, the patient attended a 30 min anesthesia consultation. This anesthesia consultation was divided into two 15 min consultations, one with an anesthesiologist and one with a nurse anesthetist.-Between the anesthesia consultation and surgery, the patient had to go to the local pharmacy to collect their analgesic treatment.-On the day of surgery: after surgery, if the patient had no adverse events, they were discharged home.-®.The postoperative follow-up was conducted via the SMS platform MemoquestThe organization of the care in ambulatory surgery before the pharmacist intervention is presented in As presented in Pharmacist consultations were carried out by a pharmacy resident. Pharmacist consultations were conducted in two steps. A first step consisting of general open-ended questions to determine the outpatient’s existing knowledge, beliefs, or apprehensions of pain medication . Using tOutpatients provided the name of their community pharmacist. Thus, after each consultation, the hospital pharmacist contacted the patient’s community pharmacist by telephone to provide a detailed account of the consultation and to inform them of any difficulties the patient might have.® Short Message Service (SMS) response tracking software. An SMS was automatically sent to outpatients at Day (D)1 and D7 after ambulatory surgery. The following items were evaluated: postoperative pain, postoperative nausea and vomiting (PONV), bleeding, fever, or any other event related to the surgery, whether the outpatient had to consult their general practitioner (GP), and whether the outpatient was satisfied with the overall management. Outpatients who did not respond to the SMS or who reported a complication were contacted by telephone by a nurse anesthetist. The following question about pain was asked: “If you had to evaluate your pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating unbearable pain, how would you evaluate your pain?”.The postoperative follow-up was performed via Memoquest®. The following question was asked: “How would you rate your satisfaction regarding your care on a scale from 0 to 10, with 0 indicating completely dissatisfied and 10 indicating extremely satisfied”?For overall satisfaction, data were retrieved exclusively from MemoquestIn this study, for ethical reasons, we used exactly the same monitoring procedure in both groups. Thus, there was no continuous monitoring for 7 days, or monitoring beyond 7 days, but rather at D1 and D7.The primary outcome was the proportion of outpatients presenting at least one painful episode with an intensity of >3 on a numeric scale from 0 to 10, at D1 or at D7 during the postoperative follow-up. The secondary outcome was the mean overall satisfaction of the outpatients. The numbers of outpatients in each treatment group were balanced with a ratio of 1:1. It was estimated that a pharmacist consultation would reduce the proportion of outpatients with a numeric pain score of >3 from 30% to 15% from a local study . For a sAll statistical analyses were performed with R software. The significance level used was 5%. No interim analysis of the primary endpoint was performed.The primary analysis was performed per protocol. Outpatients were allocated to the intervention or control group according to whether they were included in the retrospective or prospective period, and, in the prospective period, that they had received the intervention. Outpatients converted to conventional hospitalization were excluded.The proportion of outpatients with a pain score of >3 on the numeric pain scale at D1 or D7 was estimated in each group and compared between groups by Wald’s test with a 5% type I error rate. The two-sided 95% confidence interval (CI) of the absolute risk difference was estimated by Wald’s method. The mean pain levels were also obtained in each group and compared using a Student test with a 95% confidence interval.A sensitivity analysis was performed excluding outpatients with missing data in both groups.A multivariable general linear model was estimated to assess the absolute risk difference of pain in the intervention group with adjustment for pre-prescribed World Health Organization (WHO) analgesic level (1 to 3) , type oft-tests at the 5% significance level and the accompanying 95% two-sided CIs of the difference between groups were reported. For this analysis, patients with missing data on satisfaction were excluded. No multiple testing procedures were performed.Satisfaction levels were compared between the two groups by Student’s Recruitment and monitoring of each group was carried out as shown in The study compared two groups of outpatients over two different time periods. A total of 125 outpatients were included in each group. Outpatients in the control group were retrospectively included between 1 March and 31 May 2018 and outpatients in the intervention group were prospectively included between 1 March and 31 May 2019.The baseline characteristics of the outpatients are presented in p = 0.16); the male/female ratio was 1.15/1.31 without a significant difference between groups. Two types of anesthesia were used: general (GA) and locoregional (LRA) anesthesia (The mean age was 44.07 years (SD 17.38) in the control group and 47.28 years (SD 18.33) in the intervention group . According to Wald’s test  without adjustment, the difference was estimated at −17%  for the group with pharmaceutical care. In the control group, the average pain was 2.6/10 and in the interventional group, the average was 1.7/10. The difference in pain between the two groups was significant according to the Student’s t test with −0.9/10 . In the analysis with adjustment on the prescribed analgesic WHO step , anesthesia (GA or LRA), and surgical specialty , and pharmaceutical care, the difference of risk of pain in the intervention group was estimated at 16% . The multivariable analysis with effects of other variables is shown in In the control group and the intervention group, 96 (77%) outpatients and 111 (89%) outpatients, respectively, had complete data for pain assessment . The difference in satisfaction between the groups was estimated at −0.20/10 (95% CI −0.28/10 to +0.68/10).Data on satisfaction, on a scale from 0 to 10, were missing in 40 (32%) outpatients in the control group and in 15 (12%) in the intervention group. In a complete case analysis, the mean (standard deviation) satisfaction was estimated at 8.77/10 (1.96) in the control group and at 8.97/10 (1.44) in the intervention group. Using the Student’s t-test, the difference was not significant between the two groups  was consistent with the data in the literature, with an overall incidence of around 30% reported in different European ,18 or NoThe observed decrease in pain in the group that had a pharmacist consultation was probably due to the fact that analgesic treatment was planned . Indeed, it has been shown that pharmacist consultations promote adherence to treatment . MoreoveOur pharmacist consultation helped to strengthen the community–hospital link. Indeed, in the intervention group, the community pharmacist systematically received a call from the hospital pharmacist. We suggest that this community–hospital link may partly explain the decrease in pain in the intervention group. Indeed, it can be hypothesized that this transmission of information to the community pharmacist made it possible to renew the information to the patient, thus reinforcing its impact, especially regarding adherence to treatment, while allowing the hospital pharmacist to be particularly vigilant with regard to postoperative follow-up.In the literature, a clinical pharmacist consultation coordinated within a multidisciplinary team led to similar improvements in chronic pain and acute postoperative pain. Indeed, Slipp et al.  showed tThis study had several limitations. Methodologically, the two groups were compared during two different time periods . A possible seasonal or surgeon effect was reduced by including only those procedures that were performed by surgeons practicing at our center during the same months in the two different years. However, it is possible that the types of surgery changed between the two time periods, with potential unmeasured confounding factors. Since the surgical specialty adjustment did not change the effect estimate, this may not be a major confounding factor. The large inclusion criteria may lead to a risk of heterogeneity (types of surgery and anesthesia). However, these criteria were chosen to obtain a representative sample of outpatients. The retrospective nature of the study and the use of SMS software for patient follow-up limited the number of variables that could be considered such as adherence to treatment, continuing analgesic treatment or not, or the possible progression to chronic pain. However, in the literature, the transformation of acute pain into chronic pain is well-described, and the presence or absence of post-surgical pain plays an important role . Thus, tThis study is part of an ongoing protocol for the management of postoperative pain. Pain is multimodal and pain management requires coordinated and complementary actions involving a multidisciplinary team of health professionals. This study showed that adding a pharmacist to an existing pain management team could contribute to the overall effort to improve postoperative pain management. In practice, a pharmacist consultation could improve pain management by freeing up physician and nurse time. The encouraging results of this study, focusing on the contribution of pharmacists, should not overshadow the work of other team members as anesthesiologists, surgeons, nurses, and all other health professionals in the hospital or community involved in pain management. On the contrary, the aim of this study was to highlight the relevance of a pharmacist consultation in the overall management of postoperative pain and to promote the broadest possible multiprofessional collaboration. Now, a cost-effectiveness evaluation is needed before the widespread deployment of pharmacist consultations.


Percutaneous nephrolithotomy (PCNL) is accompanied by somatic and visceral pain intraoperatively and postoperatively. However, pain management strategies lack a decisive consensus. Erector spinae plane block (ESPB) is a novel paraspinal fascial block that can be used in PCNL patients, and we aimed to investigate whether ESPB will reduce intraoperative and postoperative opioid consumption and postoperative pain scores in PCNL patients.The study was randomized, controlled, and open-label. Two groups were formed as the control group (GCont) and block group (Gblock), and patients received total intravenous anaesthesia. GBlock received an ESPB catheter in addition in the prone position. Intraoperative parameters and infusion doses, postoperative rescue analgesic doses, and pain scores were recorded. The primary endpoint was intraoperative analgesic consumption, and the secondary endpoints were postoperative pain scores and analgesic consumption.-1 min-1, P < 0.001). The control group reported higher pain scores between the 30th min and 24th hours and needed more analgesics between the 1st and 6th hours postoperatively. GBlock received local anaesthetics via ESPB catheter before nephrostomy tube removal and fewer patients needed analgesics . GCont consumed more tramadol postoperatively .Sixty-four patients were analyzed. Remifentanil consumption of GCont was found to be significantly higher (GBlock: 0.0865 ± 0.030 vs GCont: 0.1398 ± 0.034, μg kgWe found that ESPB reduced intraoperative opioid consumption. It also reduced the need for rescue analgesia and postoperative pain scores during nephrostomy tube removal. We concluded that the ESPB catheter may effectively be used in analgesia management during and after PCNL operations. Systemic analgesics, regional anaesthesia, small diameter nephrostomy tube or tubeless surgery, and local analgesic infiltration techniques have been tried to improve postoperative pain management in PCNL patients.8Percutaneous nephrolithotomy (PCNL) may lead to severe postoperative pain. Acute pain may originate from the skin, muscles, renal capsule, renal parenchyma, and ureter. Nephrostomy tube removal and ambulation also cause visceral and somatic stimuli.9 in 2016 as an analgesic method for thoracic neuropathic pain. It provides unilateral analgesia of the anterior and posterior chest wall by craniocaudal spreading of the local anaesthetics (LA) applied below the fascia of the erector spinae muscle group (ESMG). By changing the injection site caudally, sensation in the abdomen and lumbar region can be blocked.10Erector spinae plane block (ESPB) was described by Forero et al.We hypothesized that ESPB would be a safe and effective analgesia option for PCNL operations and designed our study to evaluate the effectiveness of ESPB for both intraoperative and postoperative analgesia.We designated our primary goal as comparing the groups for intraoperative opioid consumption. Our secondary goals included comparing the pain scores and opioid consumption of the groups during nephrostomy tube removal, ambulation, and at certain postoperative hours.The study was conducted as prospective, randomized, controlled, and open-label in a tertiary referral hospital. We followed the CONSORT 2010 guidelines and adhered to the Declaration of Helsinki. Ethics Committee for Clinical Studies of University of Health Sciences University Turkey, İzmir Bozyaka Training and Research Hospital approved the study with approval no: 5, date: 04.07.2018. Study design was also registered and approved in the ClinicalTrials.gov with the number NCT03652103. The eligible patients were informed about the study during the preoperative evaluation and their written consents were obtained.A preliminary study was conducted for statistical power analysis based on the average intraoperative opioid consumption. The effect size was calculated as 0.936, with 95% statistical power and 5% type 1 error margin, and the sample size as at least 31 patients per group and 62 in total. 70 patients were enrolled, with the expectation of 62 patients in the end, estimating a drop-off rate of around 10-15%. The patients were assigned to either the Erector Spinae Plane Block Group (GBlock) or the Control Group (GCont) based on computer-generated randomisation.Patient admission started on September 05, 2018 and ended on March 10, 2019. Patients older than 18 years with American Society of Anesthesiologists Physical Status I or II and 2-3 cm renal stones were included. Preoperative evaluation included coagulation profile, serum creatinine levels, urinalysis, urine culture, and computed tomography scan for urinary tract. Inclusion and exclusion criteria are further explained in the flowchart. After the excluded patients, the study was completed with 64 patients .®  sensors were used for BIS monitoring. Induction was carried out with lidocaine 1.5 mg kg-1, propofol 2 mg kg-1, rocuronium 0.5 mg kg-1 and remifentanil 1 µg kg-1 IV. Total intravenous anaesthesia (TIVA) was commenced with propofol at a rate of 100 µg kg-1 min-1 and remifentanil at a rate of 0.07 µg kg-1 min-1 IV. For preventive analgesia, paracetamol 10 mg kg-1 IV was administered to all patients after the induction. The anaesthesia management of the patients was carried out by the primer anaesthesiologist of the room who was informed about the study. Hemodynamic and BIS parameters were recorded every five minutes, but the comparison of the groups for hemodynamic and BIS changes was limited to the shortest operation time to include all patients. The propofol infusion dose was titrated so that the BIS value of the patients was between 40 and 6011; the remifentanil infusion dose was titrated so that the heart rate and mean arterial pressure values remained within ± 20% of the patient’s baseline.In the operating room, patients were monitored with electrocardiogram, blood pressure, pulse oximeter, and bispectral index (BIS). 4-electrode BIS QuatroAfter intubation, patients were positioned in the lithotomy position for ureteroscopy (URS). A ureteral catheter was placed. After retrograde pyelography was performed, patients were placed in the prone position for PCNL. All operations were performed by the same primary attending surgeon, who is also the co-author. Patients in the block group (GBlock) received the ESPB in the prone position after URS. ESPB catheter insertion sites were tailored to the location of the stone, thus surgical incision area, between T7-T10 vertebra levels. With these adjustments, we aimed to align the tip of the catheter with the mid-level of the kidney nerve roots and incision site in the medulla to standardize the LA injection site in all cases.Following the marking of the thoracic vertebrae levels with a marker pen, the skin area was prepared with Povidone-iodine solution. The intervention was initiated when the transverse processes and the costotransverse joints on the relevant level were distinguished using a linear ultrasound probe. The catheter needle was inserted at a 30° angle to the skin in an in-plane and craniocaudal fashion. The tip of the needle was passed through the lower fascia of the ESMG and halted above the costotransverse joint. 5 mL normal saline (0.9%) was injected to confirm the localization of the needle tip and to aid catheter advance by hydrodissection. The catheter was advanced 2 to 4 cm inside to reach the designated level and reduce the risk of dislocation. Proper placement was confirmed with ultrasonography and then 20 mL of 0.25% bupivacaine solution was administered through the catheter for intraoperative and postoperative analgesia .-1 IV was administered to reverse the neuromuscular blockade. Patients were questioned for pain  before leaving the operating room. This was recorded as 0th-minute-NRS, and, if necessary, the rescue analgesics was administered. Rescue analgesia was planned to be tramadol 1 mg kg-1 IV (400 mg day-1 maximum) when patients’ pain scores (NRS) were 3 or above. The patients were then transferred to the post-anaesthesia recovery unit (PACU).When the surgical procedure was completed, TIVA was stopped and sugammadex 4 mg kg-1 IV was prescribed to every patient in the study every 8 h for postoperative analgesia. Patients’ questionnaires for pain scores were scheduled at the end of the operation at the 30th and 60th minutes in the PACU and at the 2nd, 6th, 12th, 24th, and 48th hours in the wards. In these questionnaires, rescue analgesic administrations were also recorded.Paracetamol 10 mg kgPatients were encouraged to ambulate on postoperative day (POD) 0, approximately 6 h after the operation. Patients in the GBlock group were administered 20 mL 0.25% bupivacaine solution via the ESPB catheter 30 min before ambulation. GCont patients did not receive any medications before ambulation with the motivation not to interfere with true analgesic consumption and to administer the same postoperative systemic analgesia protocol for both groups. Pain scores of the patients during ambulation were recorded as NRS.On POD 1, GBlock received LA dose (20 mL 0.25% bupivacaine) twice at 12-h intervals. Both groups received rescue analgesics when their NRS scores exceeded 3 out of 10.Nephrostomy tubes were removed at POD 2. Patients in the GBlock group received the same LA dose through the ESPB catheter 30 min in advance. For the same reasons as in ambulation, GCont did not receive any medication before tube removal. NRS scores of the patients during the removal of the nephrostomy tube were recorded.ESPB- or LAs related complications  were monitored both intraoperatively and postoperatively.t-test, and quantitative data that did not follow the normal distribution were compared with the Mann-Whitney U test. Chi-square test was used to compare qualitative data. Parametric test results were reported as mean and standard deviation and nonparametric test results as number and percentage or median and interquartile range.IBM Statistical Package for Social Sciences version 24 was used for statistical calculations. The compliance of the data to the normal distribution was determined by the single sample Kolmogorov-Smirnov test. Normally distributed quantitative data were compared with the independent sample P < 0.05 at the 95% confidence interval.The significance level was determined as The groups were similar in terms of age, height, weight and education level .P < 0.001). The groups were comparable in terms of other intraoperative data  . Comparison of pain scores and the number of patients who needed rescue analgesics during ambulation  and removal of the nephrostomy tube  showed significant differences between the groups. The median postoperative rescue analgesic dose was 75 mg  for GBlock and 262.5 mg  for GCont (P < 0.001)  . However< 0.001) .Heart rate, mean arterial pressure, and BIS values were measured every 5 min during the surgery, and groups were comparable regarding changes in these parameters during the operation .We did not detect any side effects or complications related to ESPB or LAs.13Efforts to provide a better understanding of the analgesic action mechanism of ESPB are on the rise. Even though it is not yet decisive, common opinion for the action of the mechanism is the LA effect at the ventral and dorsal rami of the spinal nerves. LA applied beneath the lowest fascia of ESMG spreads both craniocaudally and through the intertransverse space. This propagation provides analgesia and sympathetic blockage in a large area by interrupting the anterior, posterior, and communicating rami.14 Single-shot ESPB studies show a pain ameliorate effect lasting up to 6-12 hours.16 Even though there are case reports using LA infusions for ESPB catheters, bolus doses can be chosen, as in our study, due to the adequate duration and convenience of use. Oezel et al.17 also marked that single-shot or catheter placement for ESPB has no superiority over one another.ESPB was defined as a single shot injection block, but catheter placement for postoperative use has also been shown for various cases.18 Mostafa et al.19 conducted a study investigating pain in laparoscopic bariatric surgery with a similar insertion site for ESPB as our study. They compared bilateral ESPB with a bilateral sham block at the T7 level and reported that ESPB provides “satisfactory postoperative analgesia with decreased analgesic consumption without significant difference in postoperative pulmonary functions.” On the other hand, data regarding the intraoperative use of ESPB is in short supply and we aimed to fill this gap with our study.ESPB is mentioned in many studies as a successful postoperative analgesia method. A study of 66 patients investigated whether ESPB provides benefits for pain in laparoscopic cholecystectomy. Authors marked that the postoperative NRS scores and opioid consumption in the ESPB group were lower.21 To our knowledge we conducted the first randomized and controlled study to investigate the effectiveness of ESPB intraoperatively in PCNL patients. Our hypothesis regarding the use of ESPBs in PCNL operations is consistent with our results. Intraoperative TIVA infusion doses combined with similar BIS and hemodynamic changes in both groups, exhibited a valuable outcome. We found a statistically significant difference in remifentanil infusion doses between the groups . Painful stimuli during surgery cause stress response, which leads to hemodynamic changes (e.g. tachycardia and hypertension), increased catabolism, hyperglycemia, hypercoagulability, salt and water retention (hence edema), etc.22 Lower doses of remifentanil infusion with similar hemodynamic readings between the groups clearly indicate that ESPB performed before surgery can reduce pain during surgery. Considering the unfavorable effects of surgical stress caused by noxious stimuli,23 we can argue that the benefit of ESPB in PCNL patients may reach beyond just analgesia. This result successfully concludes our primary endpoint.ESPB has recently been shown to be effective for postoperative analgesia after PCNL operations.th minute to 24th hour postoperatively compared with GCont. But rescue analgesics were administered to GCont mostly from 60th minute to 12th hour. Both groups demanded very little opioids after 24th hour. We think that the difference in opioid use in the first 12 hour and the decrease of this difference in the following hour may point out that POD 0 is more significant for pain management in PCNL patients. In terms of postoperative total opioid consumption, patients in the block group received 75 [100] mg (median [IQR]) and the patients in the control group received 262.6 [113] mg (median [IQR]) tramadol IV (P < 0.001). These results reveal the success of ESPB in reducing postoperative pain and analgesic consumption in PCNL.Our secondary outcomes are also promising. We detected that ESPB reduced postoperative pain in PCNL patients. GBlock described lower pain scores from the 3024 These tubes are in direct contact with the skin, kidney capsule, and kidney parenchyma and create noxious stimulation in these tissues during withdrawal. To alleviate nephrostomy tube removal pain, we would need to prevent both visceral and somatic stimuli at the relevant levels. The fact that we found a statistically and clinically significant difference in pain scores during removal of the nephrostomy tube stands out as an important finding in terms of the coverage of the ESPB. As for rescue analgesia, 28 (87.5%) patients in the control group and only 5 (15.6%) in the block group demanded rescue analgesia during nephrostomy tube removal. This result, along with the reduction of intraoperative opioid doses, can be interpreted as the two most striking clinical outcomes of this study.Nephrostomy tubes increase the acute pain after PCNL and patients mainly experience distress during the tube removal.26 We determined that the average NRS of GCont patients was 4 and GBlock patients was 2 during ambulation. Thirty-one patients (96.9%) in the control group requested rescue analgesic after ambulation. In the block group, the number was 19 (59.4%) (P < 0.001). Although a statistically significant difference was found, the fact that there was no clear difference as with nephrostomy tube removal suggests that visceral stimuli with a wider range of effects are at the forefront during ambulation. ESPB increased patient comfort during ambulation but could not provide sufficient analgesia alone.Reducing pain during ambulation and thus facilitation of ambulation helps to avoid many postoperative complications such as ileus, edema, venous thromboembolism, et cetera.28 Consistent with these results, we detected no side effects or complications in any patient.Since its first publication, many studies have reported that ESPB has few or no complications and most of the known complications are due to LAs.Our study has two main limitations: open-label design and the lack of a sham block group.Open-label designs may put the integrity of studies into question. However, for our primary outcome, intraoperative dose titrations were strictly designated according to BIS and hemodynamic monitoring before the study, and we believe that the lack of physicians’ blindness did not result in an increase in bias in intraoperative data.The lack of a sham block group was intentionally decided to avoid unnecessary invasive intervention, considering that patients receive general anaesthesia for the procedure. We accept the criticism, particularly for postoperative pain follow-ups where evaluators (and patients) were aware of the questioned patient group.29 However, we believe our result on intraoperative remifentanil consumption with hemodynamic consistency is a more reliable outcome for the success of ESPB compared with subjective postoperative pain assessments.The strength of our study comes from the strict, objective measurements of intraoperative data. Pain assessments are mainly subjective and may be affected by the perception of assessment scales, environment, and patient characteristics Postoperative pain assessments are valuable and may even be irreplaceable for pain investigation studies, considering that pain itself is subjective by definition.We concluded that with decreased opioid consumption both intraoperatively and postoperatively, analgesic efficiency, low profile of complications and side effects, and ease of application, the erector spinae plane block stands out as a useful technique for pain management in patients who will undergo PCNL operation.


Rotator cuff tear (RCT) is one of the main causes of shoulder pain and dysfunction. Rotator cuff repair (RCR) is a common surgical procedure for the management of RCTs. Presence of myofascial trigger points (MTrP) as a result of surgical procedure can aggravate postoperative shoulder pain. The purpose of this protocol is to describe a randomized controlled trial design to evaluate the effect of implementing 4 sessions of myofascial trigger point dry needling (MTrP-DN) within a multimodal rehabilitation protocol following RCR surgery.Forty-six participants aged 40–75 will be recruited having postoperative shoulder pain after RCR and meeting the inclusion criteria. Participants will be randomly divided into 2 groups: One group will undergo MTrP-DN, manual therapy, exercise therapy and electrotherapy and the other will receive sham dry needling (S-DN), manual therapy, exercise therapy and electrotherapy. This protocol will cover 4 weeks of intervention. The primary outcome measure will be the Numeric Pain Rating Scale (NPRS) for pain. Secondary outcome measures will be Shoulder Pain and Disability Index (SPDI), range of motion (ROM), strength and adverse events.This is the first study to investigate the use of 4 sessions of MTrP-DN in combination with a multimodal rehabilitation protocol for postoperative shoulder pain, restriction, weakness and dysfunction following RCR. The results of this study may help to determine the effect of MTrP-DN on various outcomes after RCR surgery.https://www.irct.ir), (IRCT20211005052677N1) on 19/2/2022.This trial was registered at the ( The numbers in curly brackets comply with the numbered items in the SPIRIT checklist 2013 [Shoulder pain is the third common musculoskeletal disorder with a prevalence of 30% in lifetime . RotatorRotator cuff repair (RCR) is recommended for patients with partial-thickness tears whose symptoms have not changed after 3 to 6 months of non-operative treatments or patients with symptomatic full-thickness RCTs , 8. AddiAn appropriate rehabilitation protocol after RCR surgery plays an important role in restoration of upper extremity function . The maiSurgical procedure as a mechanical trauma to the soft tissues surrounding the surgical incision can be a potential mechanism for activation of myofascial trigger points (MTrP) . MTrPs aDry needling is an invasive treatment for MTrP relief where an acupuncture needle is inserted in the muscles. Myofascial trigger point dry needling (MTrP-DN) in combination with other physiotherapy interventions is widely used by physiotherapists around the world . Recent The primary objective of this trial is to determine the effect of MTrP-DN combined with a multimodal rehabilitation protocol compared to S-DN combined with a multimodal rehabilitation protocol on pain for patients following RCR. The secondary research objectives are to determine the effects of MTrP-DN compared to S-DN combined with a multimodal rehabilitation protocol in both groups on ROM, shoulder muscles’ strength, and SPDI. The hypothesis is that those participants who receive MTrP-DN in their rehabilitation program would exhibit greater improvements in pain, ROM, shoulder muscles’ strength, and SPDI. The null hypothesis is that those participants who receive MTrP-DN will not significantly differ from the participants who will receive S-DN in the mentioned outcomes.Study protocol for a single center, superiority, randomized, double-blinded, sham, controlled trial with a parallel group of 46 patients. The allocation ratio will be 1:1. This study complies with the recommendations of the SPIRIT 2013 statement. A CONSORT flowchart related to the stages of the study is shown in Fig. This study will be conducted in the physiotherapy clinic of Shafa Yahyaian Hospital, Tehran, Iran. The participants of this study are the patients who have undergone RCR surgery in Shafa Yahyaian Hospital by an expert shoulder and elbow surgeon at this center (MNA).The participants scheduled for open RCR due to a RCT will be recruited in this trial. The open RCR consists of a 5-cm incision using sabercut approach and detachment of deltoid muscle to reattach the rotator cuff tendons to greater tuberosity with transosseuos sutures . The sizThe patients will be assessed by a blind assessor (SA) who is a physiotherapist with more than 3 years of clinical experience. The patients will be treated by a certified clinical physiotherapist (FN) with more than 4 years of experience in MTrP-DN and the treatment of patients following RCR surgery.Each treatment session will be divided into 3 parts:The first part will be devoted to electrotherapy, during which the participants in both groups will receive conventional Transcutaneous Electrical Nerve Stimulation (TENS) on the afflicted shoulder at a frequency of 120 Hz and a duration of 50 μs for 20 minutes .The second part will be devoted to manual physiotherapy. Passive joint mobilization techniques used in previous studies will be implemented in this study as well , 19–21. The third part will be devoted to therapeutic exercises. Exercise progressions will be implemented based on the protocols presented by Giangarra et al. The exercise program in this part will include ROM and strengthening exercises, which will progress over the course of 4 weeks. The first three sessions will focus on P-ROM exercises (first and second week), followed by active assistive range of motion (AA-ROM) exercises from the fourth session (second and third week), A-ROM exercises from the sixth session (third and fourth week), and strengthening exercises from the ninth session . The instruction sheet containing exercise explanations and the relevant figures will be given to the patients as they are expected to repeat the exercises 3 times a day with recommended dosages at home and the clinic . Type ofMTrP diagnosis will be conducted by a clinician (FN) with more than 4 years of experience in the management of MTrP using the following criteria: 1. Presence of a hyperirritable nodule in a palpable taut band of skeletal muscles, 2. Visible local twitch responses to the palpation of hypersensitive spots or taut bands, or 3. Reproduction of referred pain to a distant limb and causing distant motor and autonomic responses by palpating the sensitive spots appropriately . These cParticipants will be examined for active MTrPs in the upper trapezius, lower trapezius, middle trapezius, supraspinatus, infraspinatus, subscapularis, teres minor, teres major, deltoid, levator scapulae, rhomboid major, and rhomboid minor muscles .. It should be noted that, MTrP-DN will only be used for a maximum of three muscles per session [Prior to performing the dry needling procedure, patients should lie in a proper position and the exact place of the MTrP should be cleaned with a cotton soaked in alcohol. To perform the MTrP-DN, a 0.30 × 0.50 monofilament acupuncture needle (EACU™ Acupuncture Needles) will be used by the clinician. MTrPs will be detected through flat palpation of the hyperirritable nodule in a taut band that may produce referred pain or a local twitch response. The method of MTrP-DN will be based on the approaches presented by Dommerholt and Fernandez de-las-Penas. Therefore, the patients should be placed in a prone position to perform MTrP-DN for the following muscles: upper trapezius (posterior fibers), lower trapezius, middle trapezius, supraspinatus, infraspinatus, subscapularis (posterior fibers), teres minor, teres major, posterior deltoid, rhomboid minor, and rhomboid major muscles. The patients should lie supine for the following muscles: upper trapezius (anterior fibers), anterior deltoid, and subscapularis muscles (anterior fibers). Lastly, the patients should be in a side-lying position for the levator scapula, and middle deltoid . The pre session .In the control group all the steps of applying dry needling including the position of the patient, size, and type of the needle will be similar to the experimental group. After placing the patient in the proper position and clearing the exact location of the MTrP, the needle will be inserted subcutaneously, by tapping (using the index finger) the needle into epidermis until it remains erect and can support its own weight. There will be no manipulation and twitch response and the needle will remain on the skin for 20 minutes , 30.Due to the necessity of combining therapeutic exercises with manual therapy and electrotherapy for an effective intervention, and to comply with the trial ethics for patients following RCR, the multimodal physiotherapy protocol based on the previous studies will be implemented for both the experimental and control group , 24, 31.If a patient misses 2 sessions in a row or if they are not willing to continue their treatment for any reason, the intervention will be terminated and another patient will be replaced.In order to encourage the patients, the entire rehabilitation protocol will be provided at no cost, and the patients will be closely in touch with their physiotherapist (FN) and surgeon (MNA and PT) to report their symptoms.Patients will be permitted to take analgesics like Tylenol in case of severe pain with the consultation of their surgeon.The main outcome measure for this study will be the resting pain measured by Numeric Pain Rating Scale (NPRS).This study’s key secondary outcome measure will be the glenohumeral active and passive ROM.The secondary outcomes for this study will be the Shoulder Pain and Disability Index (SPDI), strength in shoulder movements.Recruitment of participants will be conducted by receiving a list of patients who have undergone RCR at Shafa Yahyaian Hospital and an interview with them by phone. According to the telephone interview, if the patients meet the study inclusion criteria, the necessary explanations will be given to them regarding the goals and treatment plan of the research study and after receiving their verbal consent for participation, they will be invited to the hospital for MTrP diagnosis and signing the informed consent form prior to baseline measurements and initiation of the treatment plan. The baseline measurements will be collected by forms from the patients which will contain the following descriptive characteristics: 1. age, 2. gender, 3. height, 4. weight, 5. medication history, 6. dominant hand, and 7. side of the operated shoulder. After completing the baseline measurements, the patients’ activity level will be collected using the Persian version of International Physical Activity Questionnaire  Then, G-Power software (version 3.1.9.4) was used in order to determine the sample size. F-tests as a family test and Analysis of Covariance (ANCOVA) as a statistical test were utilized. According to Michener et al., Minimal Clinically Important Difference (MCID) in post-operative shoulder pain measured by NPRS was reported to be 2.17 . The eff.The participants will be recruited based on the list of patients who have undergone RCR in Shafa Yahyaian Hospital and interviewing them by telephoneAll eligible RCR participants will be randomly assigned into either MTrP-DN combined with multimodal rehabilitation protocol  or S-DN combined with multimodal rehabilitation protocol (control group) with an allocation ratio of 1:1. Randomization will be performed using variable blocks with 4 character-blocks containing letters A or B . After randomizing, the randomization schedule will be transferred into written instructions and will be placed in sequentially numbered, opaque, and sealed envelopes. The randomization process will be performed by someone who is outside the research team before the beginning of the study.Following the initial evaluations, the numbered envelopes will be given to each patient according to the ordinal number of each person admitted to the study. Once each patient enters the first treatment session, the therapist will plan the treatment intervention based on the information included in their envelope. After placing the patients in the target group, they are asked not to provide their allocation information to the examiner to prevent data contamination.The allocation sequence, enrolling, and assigning participants to interventions will be performed by the clinic’s secretary.This is a double-blinded study. The patients and the outcome assessor will be informed about the treatment process but they will be blinded regarding the allocation during the study.There will be no permission for unblinding the outcome assessor or the patients during the study, but the patients will be informed about their group allocation after the study is finished.Assessments will be performed by the fifth author (SA).NPRS will be used to assess the resting pain. This scale is scored from 0 to 10 and the patients will be asked to report their level of pain in the past 24 hours with the instruction that “0 is no pain”, and “10 is the worst pain imaginable”. The NPRS is a valid and reliable tool for patients with shoulder pain , 35.ROM will be measured using a standard 18 cm plastic goniometer. The following shoulder movements will be measured: flexion, abduction, external rotation and internal rotation to the non-painful end range . GlenohuThis index will be used to evaluate the functional status of the patients regarding their shoulder pain and disability. SPDI is a self-administered 13-item questionnaire. It consists of 2 subscales: a 5-item subscale assessing the patient’s pain level and an 8-item subscale assessing the patient’s shoulder disability in activities of daily living. Patients will be instructed to choose the number that best describes their level of pain and disability . The PerStrength will be measured with a handheld dynamometer . The measurement will be recorded during flexion and abduction in kilogram-force (kgf). Each movement will be repeated 3 times and the patient will hold each isometric contraction for 5 seconds and the average of these 3 trials will be calculated to be used in data analysis. Flexion isometric force will be performed with the patient in short sitting and arms at the side. The assessor will stand on the test side and ask the patient to raise the arm forward to 45° flexion while extending the elbow and pronating the forearm. The assessor will place the handheld dynamometer over the distal of the humerus just above the elbow and her other hand will stabilize the shoulder. Resistance will be applied downward and the patient will hold the isometric contraction for 5 seconds. Measurement of abduction isometric force will be taken with the patient in sitting position and arms at the side. The assessor will stand behind the patient and ask the patient to elevate the arm to the side with the shoulder in 45° abduction, forearm in neutral position and the thumb pointing up. The assessor will place the handheld dynamometer over the arm, just above the elbow and stabilize the shoulder with the other hand. Resistance will be applied downward and the patient will hold the isometric contraction , 39.The items reported for adverse events by Boyce et al. will be used in this study as well. In case of any adverse events depicted in Table During the study’s four weeks of the treatment plan, the patients are encouraged to regularly contact the physiotherapist (FN) and the surgeons (MNA or PT). The physiotherapist will also call the patients once a week to check on their home exercises and ask about their problems. Additionally, there won’t be any costs associated with the entire treatment to motivate the patients further.Each patient’s information including baseline measurements, personal information and outcome measures will be recorded on prefabricated forms by the blind assessor (SA). After data collection on prefabricated sheets, the information will be stored confidentially on the assessor’s laptop and all outcome measures’ data will be recorded in an Excel file for analysis.Data will be analyzed using STATA software version 16 (StataCorp LLC). In order to investigate the normal distribution of data, the Shapiro-Wilk test, mean and median similarity, analysis of histogram, and the skewness and kurtosis analysis of the data distribution will be used. In case of data’s normal distribution, parametric tests will be used to analyze the data before and after intervention. If the homogeneity of data is confirmed by Levene’s test, (ANCOVA) will be performed. In this test, the covariance variable will be the initial data value before the intervention. The significance level of the tests will be defined as 0.05. In addition to the significance index, the effect size index will be analyzed by Cohen’s d method to compare the two treatment methods for each variable to determine the effect of the intervention on each dependent variable, regardless of the sample size. According to the newly presented definition of effect size it is divided as follows: from 0.01 to 0.2: very small, from 0.2 to 0.5: small, from 0.5 to 0: medium, from 0.8 to 1.2: large, from 1.2 to 2 very large, more than 2: huge .There will be no plan for additional analysis in this study.Protocol non-adherence or lost to follow-up will be handled by intention to treat analysis.This study will be conducted under the supervision of the faculty members of the Rehabilitation Research Center, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. In addition, the Data Monitoring Committee (DMC) has no competing interest in any stages of this study and is completely independent from the sponsor.There will be no interim analysis in this study.The patients will be informed about the possible adverse events following MTrP-DN prior to signing the consent form. Also, occurrence of any adverse events following MTrP-DN will be managed by the expert physiotherapist (FN) and recorded as the adverse events of the study. If the patients are not willing to continue the trial for the adverse events or any other reason, they can leave the study.There will be no auditing trial in this study.https://www.irct.ir/.In case of important protocol modifications, protocol amendments will be updated on The informed consent form will be prepared according to the standards of the Ethics Committee of Iran University of Medical Sciences and will be obtained from the patients by the hospital’s secretary. All eligible patients will be informed about the interventions and the adverse events prior to signing the consent form. In the Ancillary studies are not applicable in the current study.All patients’ data will be archived in a unique confidential manner at all stages of the trial and this confidentiality will be protected during and after the trial.For those patients who experience major adverse events following MTrP-DN or any other harms caused due to participating in the trial, the research team will compensate for all the occurred harms throughout the trial.This study aims to publish the results in an international peer-reviewed journal and also present the results in a recognized national or international conferences.In the present study, the Vancouver guideline was implemented for determining the authorship eligibility.For granting public access to the full protocol, participant-level dataset and statistical code, sending a reasonable email to the corresponding author will help an eligible investigator to receive the required information.Postoperative shoulder pain is a common complaint in patients after RCR . The proSince exercise therapy after RCR surgery is an essential part of a physiotherapy treatment plan, an appropriate progressive exercise program will be included in this protocol to be followed during the treatment and also at home . ExercisThe efficacy of combining manual therapy, exercise therapy, and electrotherapy has been proved in previous studies for patients with rotator cuff disease , 43. TheDue to the lack of similar studies for the management and rehabilitation following RCR surgery, the implementation and results of this study will make a new contribution to the rehabilitation of patients with postoperative shoulder pain and dysfunction, and it may also help to establish a new line of research for adding MTrP-DN in rehabilitation protocols following RCR surgery.This study protocol is the first version, finalized in October 2022, and is recruiting participants. The recruitment process is expected to take 5 months.


N = 203). Neither pain nor foot posture were different between groups. The physical and mental components of SF-12 were worse in rheumatoid arthritis and Ehlers–Danlos syndrome patients, and the physical component was worse in systemic lupus erythematosus patients, compared to controls. A significant difference was also observed in the mental component between systemic lupus erythematosus and Ehlers–Danlos syndrome patients, the latter having the lowest values among the groups. We can conclude that women with rheumatoid arthritis, Ehlers–Danlos syndrome, systemic lupus erythematosus and foot pain perceive a worse quality of life. There are no significant changes in foot posture. Pain and health-related quality of life are independent of foot posture.The aim of this work was to investigate the relationship foot pain and foot disability have with HRQoL in groups of women with RA, SLE and EDS, in comparison with a control group. A cross-sectional study was carried out with females with one of these conditions and a control group. The SF-12 questionnaire was used to collect data about quality of life. The type of foot was classified according to the footprint and the foot posture index. A total of 156 patients and 47 controls participated in the study ( Rheumatoid arthritis (RA), Ehlers–Danlos syndrome (EDS) and systemic lupus erythematosus (SLE) are rheumatic diseases that predominantly affect women ,2,3. MusFoot problems may affect the normal gait cycle, alter foot load patterns, inhibit the patient’s movement and, as a consequence, affect physical activity levels and general activities of daily living, which may result in a worse quality of life ,14. PainA common feature that characterises these rheumatic diseases is that foot involvement may affect HRQoL. However, to the best of the authors’ knowledge, there are no previous studies that compare foot characteristics and their impact on the quality of life in women with AR, EDS and SLE. Therefore, the aim of this work was to investigate the relationship that foot pain and foot disability have with HRQoL in groups of women with RA, SLE and EDS, in comparison with a control group.This is a cross-sectional study, conducted according to the protocol and good clinical practice principles and Declaration of Helsinki statements. The participants were recruited consecutively between January 2016 and July 2022, and gave their informed consent to be included. The study was approved by the Bioethics Committee of the Government of Andalusia and authorised by the Head Office of the Clinical Area of Podiatry of the University of Seville.For participant recruitment, the rheumatology units of the hospitals Virgen de Valme, Virgen del Rocio and Virgen Macarena in Seville were contacted, as well as several associations of patients . A comparison group was obtained from volunteers who did not suffer from any rheumatic disease.As most patients in these three rheumatic diseases are female, the current study included only women. The inclusion criteria were adults with a diagnosis of RA according to the criteria of the American Rheumatism Association , or withClinical and demographic data were collected, including age, weight, height, years since diagnosis of the rheumatic disease, foot pain, foot functionality, foot-related disability and quality of life.Patients were examined and the foot posture index (FPI)   was usedPain was measured using the 11-point Numeric Range Scale (11-NRS) . This raFoot functionality was measured using the foot function index (FFI) . This isDisability related to foot pain was measured using the Manchester foot pain and disability index (MFPDI) . The valThe SF-12 questionnaire was used to collect data about the quality of life , which h® software 34 version  was used to calculate the arch index [Footprints were obtained from all participants. AutoCadch index . This inch index .s2 is the sample variance based on a previous study on Spanish people in which SF-12 was measured [α is the type I error, β is the type II error and d is the minimum difference to be detected. Therefore, the following result was obtained:The minimum sample size was calculated using the variables SF-12 Physical and Mental as a reference, with the following formula used to compare mean values between populations:measured , α is thThus, at least 42 women were needed in each group to compare the mean values. In this study, 56 women with RA, 48 with EDS, 52 with SLE and 47 controls were recruited.The analysis of the data was carried out using the statistical software IBM SPSS Statistics 25 version . The descriptive data provided the mean values and the standard deviations or the absolute frequencies and percentages depending on whether the variables were scalar or categorical.The association among qualitative variables was evaluated using the chi-square test. Corrected typified residuals were used to know which relationship between variable categories was significant in the different groups.p-values were lower than 0.05. As there were more than 2 categories, the control group was chosen as the reference variable. To evaluate the goodness-of-fit of the logistic model, the pseudo-R-squared (Nagelkerke’s R2) was provided. This pseudo-R-squared looks the same as R-squared as it is on a similar scale, ranging from 0 to 1 with higher values indicating a better model fit. The confidence level a priori was 95%.Normality tests were conducted for the inferential analysis to determine the most appropriate test to use. An inferential analysis using the one-way ANOVA or Kruskal–Wallis statistical test was performed. When significant differences were found, multiple comparisons were made using post hoc tests . A multinomial logistic regression model was then carried out including only the variables whose 2 and mean time from diagnosis 14.8 ± 12.8 years), 48 had a diagnosis of EDS  and 52 suffered from SLE . Forty-seven women formed the control group . The descriptive data of the study variables are summarized in One hundred and fifty-six female patients and 47 controls participated in the study (N = 203). Fifty-six of them were RA patients  and ankle pain and toe deformities were more frequent in participants with RA .The association among foot pain location and toe deformities between groups was evaluated using the chi-square test. The percentage of women with forefoot pain was not different between the disease groups, rearfoot pain was more frequent in EDS patients , the women in all disease groups showed more foot pain and disability than controls according to the results of the FFI and MFPDI total scores. Previous studies reported similar results ,27,44.FFI has been widely used in rheumatology studies, as it has previously been recommended for treatment assessment in rheumatology . Our parAlthough women with rheumatic diseases show significant differences in the punctuation of FFI and MFPDI compared to controls, the foot-related variables that best correlate with a poorer quality of life are the presence of pain in the ankle for RA and EDS women, or in the forefoot in SLE patients. Forefoot pain in SLE may be the consequence of severe local joint inflammation presenting in metatarsophalangeal joints ,28. The However, the results obtained from the present study show that foot posture does not differ significantly in either group. For this reason, this variable should not be considered as the cause of poor HRQoL in the present sample. Some authors sustain that FPI shows high values (pronated feet) in patients with RA , EDS 2121 and SLThis study has certain limitations. Firstly, the potential impact of pain medication on HRQoL was not considered. However, we think that even with the use of pain alleviating medication, pain levels were similar between the four groups and only the presence of pain in different areas of the foot was significantly related with impaired HRQoL. The evolution time of pain can affect HRQoL, but this item is not included in the questionnaires and scales used in this research, so it was not analysed. In addition, footwear was not considered. The use of inappropriate shoes  is very According to the results shown, we can conclude that women with RA, EDS, SLE and foot pain perceive worse HRQoL. Metatarsophalangeal deformities are more prevalent in rheumatic diseases; however, there are no significant changes in foot posture. Pain and HRQoL are independent of foot posture.