BackgroundThis cross-sectional study aims to evaluate pain management's success in limiting admissions and assesses remote care's effectiveness for optimal pain relief. By utilizing data from severe COVID-19 inpatients in Prishtina, Kosovo, this study offers insights into the challenges posed by the pandemic and innovative care approaches aimed at improving patient well-being.MethodologyThis cross-sectional study includes 55 patients with severe COVID-19 after hospital discharge. All study participants completed the questionnaire in the presence of a clinical pharmacologist. The questionnaire of this study consisted of three parts: sociodemographic data (first part), the Intensity and Characteristics of Toothache (IaCofT) and headache (second part), and pharmacological treatment of headache and dental pain (third part). The questionnaire on IaCofT and headache was created with some modifications of the Modified Dental Pain Screening Questionnaire (M-DePaQ).Descriptive statistics were conducted using Prism version 10.0.1 (Windows and Mac).Resultsn = 49) of the participants experienced pain during hospitalization with COVID-19, while 72.72% (n = 40) of them experienced pain after hospital discharge. Of the participants, 32.7% (n = 18) experienced dental pain, whereas 60% (n = 33) reported having headaches. Regarding the pain scale, more than two-thirds  of the participants had moderate to moderately severe pain, and in 70.9% (n = 39) of the cases, the pain occurred episodically. The absolute majority  of study participants reported the use of analgesics for pain management. Paracetamol  and ibuprofen  were the most commonly used analgesics for pain management.According to the study data, 89.1% (ConclusionsThis study highlighted the prevalence of headache and acute dental pain in these patients. The majority of the study participants were convinced by the healthcare system and were highly dependent on pharmacological treatment for headaches and acute toothache during the COVID-19 peak. The study results showed that the pain was proven to be successfully treated pharmacologically with analgesics such as paracetamol, ibuprofen, and diclofenac. Telemedicine is expected to become an important healthcare practice in the post-COVID-19 era. Therefore, the introduction of this service could be considered. The 2019 outbreak of COVID-19, caused by SARS-CoV-2, has posed significant challenges to health systems worldwide. As the virus continued to spread rapidly, physicians, dental teams, and patients faced an increased risk of transmission due to close proximity during medical and dental procedures and the formation of aerosols . In respTelemedicine gained prominence as attempts were made to overcome service limitations. The Prishtina MOH introduced a 24/7 hotline for general medicine and dental consultation, ensuring remote access to professional help in emergencies. These advances in telecommunications allow remote management of patients, minimizing the number of in-person visits while ensuring timely care . The stuNevertheless, some reports question telemedicine. Some disadvantages of telemedicine have been mentioned by Balestra: limitations in performing complete physical examinations, technical barriers, potential legal problems, and various regulatory obstacles . AccordiAll these disadvantages have become less important in the COVID-19 pandemic, as face-to-face contact increases the risk of disease transmission.During August-September 2021 of the COVID-19 pandemic peak in Kosovo, 38.8 deaths were recorded per 100,000 inhabitants  11.25) as well as the age group 31-40 years  regarding research participants' use of analgesic for pain relief while they were sick with COVID-19 and after being released from the hospital.Moreover, according to statistical analysis, a significant difference was found between the age group 41-50 years and the age group 20-30 years , while 78.2% (n = 43) of the participants were affected by sleep disturbances. Most of our study participants  belonged to the age group of 41-70 years, and all of them were affected by a severe form of COVID-19.Regarding the severity of pain, in our study, the prevalence of moderate-to-severe pain was 72.72%  of participants used analgesics for toothache/headache treatment during the COVID-19 pandemic, reflecting a significant reliance on pharmacological management. Paracetamol (83.6%), ibuprofen (25.5%), and diclofenac (14.5%) were the most used analgesics in our study. Similarly, a study by Patel et al. [Our study found that 96.4%  in their health system's ability to diagnose the virus. In contrast, results from participants in Makkah, Saudi Arabia (2023) [The results of this study show that health systems' confidence in diagnosing COVID-19 varies widely across regions. In Kosovo, participants expressed relatively high confidence (a (2023)  showed an = 43) of participants sought treatment on the recommendation of a physician, suggesting that there was substantial use of medical help for acute dental pain or headache during the COVID-19 pandemic. In our study, the team consisted of physicians and dentists, which was also observed in a study by Suh [Our study found that 78.2% (y by Suh . This coy by Suh  and Sujay by Suh  had acceThe novelty of COVID-19 and the lack of similar studies make direct comparisons difficult. Unlike previous studies that did not include patient outcome data , our stuLimitationsOne limitation of this study was the difficulty in recruiting a larger number of participants. In addition, there was difficulty in motivating participants to complete an electronic survey and the failure to include other forms of pain in the group of study participants. Furthermore, some study participants failed to properly complete documentation, leading to their exclusion from the study.This study showed the prevalence of headache and acute dental pain in severe COVID-19 patients. The majority of participants in our study were confident in the healthcare system and relied heavily on medical interventions to treat dental pain and headaches during COVID-19. Pain was shown to be successfully treated with analgesics such as acetaminophen, ibuprofen, and diclofenac.The results of this study may be a starting point for a more comprehensive review of the existing medical approach to patients with dental pain and headaches and the increased benefits of telemedicine services. The introduction of telemedicine services may be particularly useful in improving patient care and addressing accessibility issues to professional care.Telemedicine could be a useful alternative to pain management for patients who do not have physical access to healthcare facilities. It is recommended that the cost-benefit of telemedicine services for patients with headaches and dental pain be investigated in another specific study. The most commonly used analgesics were acetaminophen, ibuprofen, and diclofenac. This pattern of analgesics fits with pain management practices in other surveys.


Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. Randomized, prospective and comparative study at Dr. Mário Gatti Hospital.  Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG) received local infiltration (0.75% ropivacaine) under general anesthesia; the spinal group (SG) received subarachnoid block (2 ml of 0.5% bupivacaine). Analgesic supplementation consisted of fentanyl for LG and lidocaine for SG. Postoperative pain intensity, sphincter relaxation, lower-limb strength, time to discharge, analgesic dose over one week and adverse effects were assessed. Eleven LG patients (52.4%) required supplementation, but no SG patients. Pain intensity was higher for LG up to 120 min, but there were no differences at 150 or 180 min. There were no differences in the need for paracetamol or tramadol. Times to first analgesic supplementation and hospital discharge were longer for SG. The adverse effects were nausea, dizziness and urinary retention. Pain intensity was higher in LG than in SG over the first 2 h, but without differences after 150 and 180 min. Time to first supplementation was shorter in LG. There were no differences in doses of paracetamol and tramadol, or in adverse effects. This surgical procedure can be conducted by means of local infiltration,Quick recovery, along with adequate and safe postoperative analgesia, is an important factor in relation to hospital discharge after any surgical procedure. The adverse effects and complications associated with the various techniques might increase the length of stay at the hospital, patient morbidity and healthcare costs.Spinal anesthesia is widely used because of its simplicity, the quality of the analgesia obtained and the induction of anal sphincter relaxation that it provides, which is required for hemorrhoidectomy.,Perianal infiltration is a simple, easy-to-perform technique that is safer than spinal anesthesia because it does not involve the neuraxis. Long-acting local anesthetics are used to achieve longer analgesic effects. Some studies have shown that local infiltration with ropivacaine was effective for hemorrhoidectomy.No consensus yet exists regarding the efficacy of local infiltration, the duration of its effect or the associated adverse effects and complications. Therefore, studies that assess both the analgesic and adverse effects are necessary.The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare the time to discharge, the adverse effects and the complications.This was a randomized controlled trial. Data were collected at Hospital Dr. Mário Gatti between December 2014 and November 2015.This study was firstly approval by the ethics committee of Universidade Federal de São Paulo (CAAE 3714054.9000.5505). Patients undergoing hemorrhoidectomy were included in the study after they had signed an informed consent form. The study was registered at ClinicalTrials.gov (NCT02839538).The sample size calculation was performed using SPSS for Windows. It was assumed that the response rate to the treatment tested would be a 30% reduction in pain intensity, with 95% power (beta), P = 0.05  and an estimated standard deviation of 2.44. Therefore, the sample size would need to be 18 participants per group.All patients undergoing hemorrhoidectomy in the same institution between December 2014 and November 2015 were included. The following patients were excluded from the study: those with associated conditions (fistula and fissure), infection of the puncture site, cognitive disorders, psychiatric illnesses, myocardial ischemia, arrhythmia or any other painful syndrome; those using anticoagulants or analgesics (within the last two weeks before the intervention); illicit drug users; and pregnant women.Randomization was performed by an author who did not participate in the anesthesia and assessment, using the Randomizer software. The group assignment of each participant was placed inside an envelope numbered from 1 to 40. Participant allocation was performed via a draw, in which the envelopes were opened before the start of the intervention, at the surgical center. The participants were thus randomly selected to receive one type of anesthesia. It was impossible to read what was inside the envelopes. One surgeon performed all of the infiltration procedures, and one anesthetist performed both the general anesthesia for the local infiltration group (LG) and the spinal anesthesia for the spinal anesthesia group (SG). Another investigator who was not involved in the study evaluated the participants.The participants were allocated to one of two groups. LG received surgery with local infiltration and general anesthesia, and SG received spinal block.Monitoring during anesthesia was performed via pulse oximetry, cardioscopy, non-invasive blood pressure measurement and (in LG) capnography.In LG, general anesthesia was administered using propofol (3 mg/kg), atracurium (0.5 mg/kg), propofol infusion (100 µg/kg/min), oxygen and a laryngeal mask. Next, the same surgeon performed local infiltration with 20 ml of 0.75% ropivacaine, which was injected between the internal and external anal sphincters using a 0.8 x 30-mm needle.In SG, puncture was performed with the patients in a sitting position, using a 27G Quincke needle between L4 and L5 or between L5 and S1, with injection of 2 ml of 0.5% hyperbaric bupivacaine. After 10 min, the anesthesia was tested via the pinprick method, and patients whose score was zero on the pain scale proceeded to surgery.Analgesic supplementation was performed as needed, using 50 µg of intravenous fentanyl in LG and infiltration of 5 ml of 1% lidocaine in SG. Postoperative analgesic rescue was initially performed using acetaminophen 500 mg/dose (maximum: 4 g/day). The cases without adequate relief 1 h later were given a tramadol dose of 50 mg.Upon discharge, the participants received a form, to be returned one week later, to record the following data: time of pain onset, amount of analgesics taken and adverse effects. Pain intensity was assessed on a numerical scale (from zero to 10).The following outcomes were also assessed: need for intraoperative analgesic supplementation; sphincter relaxation (under conditions appropriate for surgery); postoperative pain intensity on a rating scale ranging from 0 to 10 at the end of surgery (T0) and every 30 min afterwards up to 180 min; dose of postoperative analgesic; time to first supplementation (from anesthesia to first dose); motor function of the lower limbs every 30 min until discharge in accordance with the Bromage scale ; and time to hospital discharge .Statistical analyses were performed using SPSS for Windows. The following tests were applied: Mann-Whitney test for body mass index, pain intensity and first need for analgesic; chi-square test for gender, physical status and adverse effects; and Student’s t test for age, body weight, height, acetaminophen and tramadol dose, duration of surgery and time to discharge. The significance level was set at P ≤ 0.05.Forty patients of both genders, aged 18 to 60 years, who presented physical status 1 or 2 of the American Society of Anesthesiologists classification and were scheduled to undergo hemorrhoidectomy, were included in this study. The protocol sequence is shown in a flowchart . The groEleven participants (52.4%) in LG  (35.7 ± 42.3 µg) but none of the patients in SG required intraoperative analgesic supplementation with fentanyl.The pain intensity was higher for LG at 0, 30, 60, 90 and 120 min after surgery, but there was no significant difference at 150 or 180 min . Time toAll of the participants in SG scored zero on the Bromage scale, 210 min after the end of surgery. The time to discharge, calculated from the onset of anesthesia, was longer for SG .The participants reported the following adverse effects: nausea , dizziness  and urine retention .The pain intensity was higher for LG than SG over the first 2 h after hemorrhoidectomy. The time to the first analgesic supplementation was significantly shorter, with no difference in the analgesic supplementation or in adverse effects.This study investigated infiltration because this technique is simple, and recovery is quick; thus, it is appropriate for surgery in outpatient settings. Infiltration alone might promote an adequate level of analgesia for surgery, but patients remain able to perceive the surgical manipulation. This feeling is often uncomfortable; therefore, medication needs to be administered, to sedate the patients. Infiltration can be performed in combination with sedation,According to the authors of one study, the quality of postoperative analgesia is better when the full posterior perineum is blocked. However, the technique involved is more complex, and higher doses of anesthetics are used.,As in other studies,,The volume of anesthetic reported in the literature has varied widely, from 6 ml,The peak plasma concentration is achieved 15 min after ropivacaine infiltration into the subcutaneous tissue.In another study, 47% of the patients reported pain and discomfort during surgery. However, the dose used was small (6 ml of 0.25% bupivacaine),Local infiltration with 0.25% bupivacaine has been reported to promote excellent sphincter relaxation.In one study, there was no difference in pain score after 24 h, after local or spinal anesthesia, except at the 6-h assessment, when the intensity was higher for the group that received spinal anesthesia. Postoperative analgesia was excellent in more than 90% of the participants who received local infiltration, but was excellent in less than 50% of the group that received a spinal block.In one study in which bupivacaine infiltration was performed in combination with general anesthesia, the analgesic effect lasted for approximately 10 h,It should be noted that this study presents the limitation that it was not possible to blind the groups.In this study, the length of hospital stay was shorter for LG than for SG, which corroborates the results reported in the literature.In this study, urinary retention occurred in 19% of SG. However, the incidence of this complication reported in the literature is higher: between 30%Following spinal anesthesia, the reported rate of headaches is 24%.In this study, local infiltration showed less postoperative analgesic efficacy, but recovery was faster. In clinical practice, analgesia might be enhanced through preventive multimodal combination of analgesics at the end of surgery. Infiltration might be an alternative option for patients undergoing hemorrhoidectomy.


Burning mouth syndrome (BMS) is an oral-facial pain disorder involving the central and peripheral nervous systems, but the evidence for altered pain sensitivity remains inconclusive. The aim of this study was to investigate pain sensitivity and oral health-related quality of life (OHRQoL) in patients with BMS and to assess the relationship between them.Fifty Chinese patients with BMS (57.82 ± 11.2 years) and fifty age- and gender-matched healthy subjects (55.64 ± 10.1 years) participated in the study. The Pain Sensitivity Questionnaire (PSQ) was used to assess participants’ pain sensitivity. The Oral Health Impact Profile (OHIP-14) was used to evaluate participants’ OHRQoL.The PSQ total score (p = 0.009), the PSQ minor score (p = 0.003) and the OHIP-14 score (p<0.05) of patients with BMS were significantly higher than those of the healthy subjects. Simple linear regression showed that the PSQ minor score was significantly associated with the OHIP-14 score in patients with BMS .Patients with BMS have higher pain sensitivity than healthy subjects. Reducing pain sensitivity might help to improve the quality of life of patients with BMS. Burning mouth syndrome (BMS) is a chronic oral mucosal pain that often causes a persistent burning sensation and sensory dysfunction with a lack of clinical and laboratory findings , 2. The Above-average pain sensitivity may be a risk factor for progression to chronic pain . StudiesThe impact of BMS on patients’ lives is complex and multifaceted, and a persistent burning sensation adversely affects patients’ quality of life , 35. HeaThis cross-sectional study was conducted from January 2021 to January 2023. The study sample consisted of patients diagnosed with BMS who were attending the dental clinic at The First Affiliated Hospital of Zhengzhou University. The study protocol followed the principles established in the Declaration of Helsinki and was approved by the Medical Research Ethics Committee of the First Affiliated Hospital of Zhengzhou University(2020-KY-457). All patients were volunteers, provided informed consent to participate and received no remuneration.The inclusion criteria for the diagnosis of BMS in this study were as follows : (1) patThe target sample size was set by fixing a power test value (1-Beta) no less than 80% associated with a significance of no more than 5% and an effect size value of 0.6. The calculations were computed using G*power software (v 3.1.9). Finally, 50 BMS patients and 50 healthy subjects were enrolled in this study.Patients with BMS and healthy subjects were assessed by the Pain Sensitivity Questionnaire (PSQ), a clinically useful and effective self-assessment method for pain perception in patients with chronic pain based on pain intensity scores in everyday life situations. The PSQ consists of 17 items that are scored on a scale from 0  to 10 (the worst pain imaginable) on a numerical rating scale (NRS). The total PSQ score consists of two subscales (PSQ minor and PSQ moderate) and is the average score for all but three nonpain items. Mean scores of < 4, 4–6, and > 6 were considered mild, moderate, and severe pain sensitivity, respectively. Although the correlation between PSQ minor scores and experimental pain intensity ratings was better than that between total PSQ and PSQ moderate scores, this study collected both total PSQ scores and PSQ minor scores. The Mandarin version of the PSQ has been validated in Chinese groups .The Oral Health Impact Scale (OHIP-14) is the most widely used instrument to assess OHRQoL. The OHIP-14 comprises 14 items that describe 7 domains: functional limitations, physical pain, psychological discomfort, physical disability, mental disability, social disability, and social handicap. Items are scored on a 5-point Likert scale as follows: 0 = none; 1 = rare; 2 = sometimes; 3 = often and 4 = very often. The OHIP-14 total scores, ranging from 0 to 56, were obtained by summing the scores for all 14 items, with higher OHIP-14 scores indicating worse OHRQoL. The Chinese version of the OHIP-14 has been validated in Chinese groups .2 value represents the explanatory power of the regression model.All analyses were performed using SPSS software version 22.0 . A descriptive study was performed on each variable. The two groups were compared using Student’s t test, chi-square test, or Mann‒Whitney U test. Simple linear regression was used to determine the correlation between the PSQ score and the OHIP-14 score. P < 0.05 was accepted as statistically significant. The RThe demographic and clinical characteristics of the subjects are shown in Table The healthy subjects consisted of 4 males and 46 females, aged 33 ~ 79 years old, with an average age of 55.64 ± 10.1 years. The duration of BMS oral symptoms had a wide range, from a minimum of 1 month to a maximum of 48 months. The mean duration of disease was 9.62 ± 8.64 months. Most patients reported symptoms on the tongue , followed by the anterior hard palate  and labial mucosa . All fifty patients (100%) had the typical burning mouth pain. Thirty-seven (74%) patients reported dry mouth, and 25 (42%) patients reported dysgeusia. Nineteen patients (38%) reported the classic symptom triad of BMS, including burning mouth symptoms, taste disturbances, and xerostomia. Thirty-six patients (72%) reported symptoms persisting throughout the day. Eleven patients (22%) reported asymptomatic waking in the morning, increasing gradually throughout the day and peaking in the evening. Three patients (6%) reported intermittent symptoms on some days.PSQ subscale scores of patients with BMS and healthy controls are shown in Table The OHIP-14 scores of patients with BMS and healthy controls are shown in Table Simple linear regression analysis was performed on the OHIP-14 score and PSQ score of patients with BMS. There was no significant correlation between total PSQ scores and OHIP-14 scores , but PSQ minor scores were significantly correlated with OHIP-14 scores   to detect pain thresholds. Those studies found that the warmth detection threshold (WDT) , 24–26 aAs recommended by IMMPCT, quality of life assessment can help in the management of chronic pain . PreviouIn our study, simple linear regression analysis was used to find a significant correlation between pain sensitivity and quality of life in patients with BMS. A higher level of pain sensitivity worsened the OHRQoL of BMS patients, which had not been previously reported. Similar reports have been made in other types of diseases. A correlation between pain threshold and quality of life has been reported in patients with fibromyalgia . ReducinThis study presented some limitations and required a degree of caution in interpreting our findings. This was a cross-sectional survey conducted at a single point in time, with a limited sample size and no follow-up surveys. In this study, although we reported a correlation between the two, we could not prove whether patients with increased pain sensitivity were predisposed to BMS or whether long-term chronic pain stimulation during the course of BMS resulted in increased pain sensitivity, and longitudinal studies are needed to further clarify the correlation. The effectiveness of this research is, therefore, exploratory and should be interpreted with care on account of the small size of the sample. Future studies with larger samples of BMS patients are warranted to exploring the relationship between pain sensitivity and BMS, as well as potential interventions to reduce pain sensitivity in BMS patients.The quality of life of patients with BMS was significantly reduced. Compared with the healthy subjects, patients with BMS presented significantly heightened pain sensitivity. There was a correlation between the two. Reducing the pain sensitivity of BMS patients may be a potential way to improve the quality of life of patients with BMS, which is worthy of further exploration.


Background and Objectives: The most common treatment procedure for periodontitis and gingivitis is scaling and root planing, which is perceived as a painful dental treatment. The current study aimed to assess pain perception and analgesics consumption after scaling and root planing (SRP) in patients with stage II and stage III periodontitis. Materials and Methods: Before starting the SRP, all the periodontal parameters, such as probing depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL), were measured. The anxiety level of the patients was also assessed using the modified dental anxiety scale (MDAS) questionnaire. Pain perception of the patients was recorded with the visual analog scale (VAS) after performing the SRP. Patients were asked to mark their pain level on the VAS sheet after two hours, four hours, eight hours, 24 h, and 48 h after the periodontal treatment. The following cut-off points were used for the pain intensity in the VAS: 0 = no pain, 1–4 = mild pain, 4–6 = moderate pain, and 7–10 = severe pain. Patients were advised to take analgesics if the pain was intolerable. Multivariate logistic regression was performed to conduct the association of all dependent variables and the pain perception of patients. A nonparametric Friedman test was conducted to assess pain perception at different times. Results: A total of 52 patients including 32 males and 20 females participated in the current study, with a mean age of 43.10 ± 12.33 years. Multivariate analyses showed that MDAS and analgesic consumption is significantly associated with pain perception. Other clinical variables are not associated with pain perception. The Friedman test exhibited that pain perception is significantly associated (p < 0.05) with time. Conclusions: Analgesic consumption and anxiety level are significantly associated with pain perception after SRP treatment. Pain is defined as an emotional experience along with unpleasant senses which are associated with the potential damage of the tissue . Most pePain is a complicated sensory process. Previous studies stated that many factors such as previous experience and anxiety influence pain perception ,6. HowevIn addition, the treatment of any periodontal disease is based on the classification of the periodontitis. The classification of periodontal diseases and conditions was published in 1999 . HoweverThe current prospective study was conducted in the College of Dentistry, Prince Sattam Bin Abdulaziz University. The Standing Committee of Bioethics Research (SCBR) of Prince Sattam Bin Abdulaziz University approved this study protocol (SCBR-092-2022). Moreover, the study was conducted according to the guidelines of the Declaration of Helsinki. All the patients included in this study followed the convenience sampling method. The following inclusion criteria were used to include all the patients in the current study: patients, aged 20 to 65 years, who were diagnosed with the Class II and Class III stages of periodontitis in at least 12 teeth, as well as patients who required oral prophylaxis and non-surgical therapy. However, patients who did not receive any prior periodontal surgical therapy were included in the current study. On the other hand, pregnant and lactating patients, patients who had taken anti-depressants or sedatives, analgesics 24 h before the treatment, mentally challenged patients, patients who had periodontal therapy with antibiotics within the last three months, smoker patients, and patients who testified acute and chronic pain before starting the treatment were excluded from the current study.The study was explained to all the patients who fulfilled the inclusion and exclusion criteria and informed consent was obtained from all the participants. The demographic data of the patients were recorded before starting the periodontal treatment. The anxiety levels of the patients before starting the treatment were assessed using the modified dental anxiety score (MDAS) questionnaire .Routine periodontal clinical examination was performed by evaluating probing depth (PD) , bleedinA visual analog scale (VAS) was used to measure the pain after the periodontal treatment. This scale consists of a horizontal line starting from zero to 10 where zero indicates no pain and 10 indicates the intense level of pain. Patients were asked to mark their pain level on the VAS sheet after 2 h, 4 h, 8 h, 24 h, and 48 h after the periodontal treatment. The following cut-off points were used for the pain intensity in the VAS: 0 = no pain, 1–4 = mild pain, 4–6 = moderate pain, and 7–10 = severe pain . PatientAll the statistical analyses were performed using the SPSS software, version 27 . The normality of the data was checked using the Shapiro–Wilk test. Descriptive data were analyzed with frequency distribution. Multivariate logistic regression was performed to conduct the association of all dependent variables and the pain perception of patients. A chi-square test was performed to identify the distribution of MDAS and analgesic consumption with gender. A nonparametric Friedman test was conducted to assess pain perception at different times. When the Friedman test was significant, pairwise comparisons based on the Wilcoxon rank test were made, implemented with Bonferroni correction. Statistical significance was set at 0.05.A total of 52 patients including 32 males and 20 females participated in the current study with a mean age of 43.10 ± 12.33 years. A total of 33 and 19 patients were diagnosed with stage II periodontitis (63.50%) and stage III periodontitis (36.60%), respectively. Moreover, a total of 19, 21, and 12 patients were diagnosed with grade A, grade B, and grade C periodontitis, respectively. The majority of the patients were not anxious (65.4%) before the treatment and 80.80% of patients did not take analgesics after the SRP treatment. None of the patients experienced severe pain after the treatment. Mild and moderate pain were observed throughout 48 h. However, the majority of the patients recorded ‘no pain’ after the treatment. The frequency of the pain was displayed in Multivariate analyses showed that MDAS and analgesic consumption is significantly associated with pain perception. Other clinical variables are not associated with pain perception . Moreovep < 0.05) with time (p < 0.05) with each time difference, except for 24 H and 48 H (The Friedman test exhibited that pain perception is significantly associated (ith time . Therefoand 48 H .This study aimed to assess pain perception and analgesics consumption after SRP in patients with stage II and stage III periodontitis. The outcome of the study showed that analgesic consumption and dental anxiety are associated with pain. Moreover, pain is also associated with time, except for 24 H–48 H. The current study showed that the pain perception of males and females is not significantly different at the time point. Even though it was mentioned in the previous study that the pain scale for female patients was higher than that of male patients , the curAs stated in the previous studies, female patients are more anxious about dental treatment compared to male patients ,23,24. HThe perception of pain is usually linked to the severity of the periodontal disease. The more aggressive the periodontal condition, the more pain experienced by the patients . The curPeriodontal treatment procedures might have associated with the level of pain which results in the consumption of analgesics oftentimes. In this study, analgesics were prescribed to patients if the pain was intolerable. It showed that 20% and 18.80% of female and male patients were taking analgesics after the SRP treatment. However, the majority of the patients did not take medication for pain. Even though more female patients were taking analgesics compared to male patients, the ratio was not significant, and no significant differences were observed between analgesic consumption and gender. Experienced practitioners play an imperative role in postoperative pain. SRP could be painful if patients are not treated sophistically which could lead to analgesic consumption. In the current study, all the professional periodontists performed the SRP procedure which might report a lower percentage of analgesic consumption. Although analgesic consumption is not related to gender, the statistical analysis of this study exhibits that analgesic consumption is significantly associated with VAS at different time points. The current study used the VAS for assessing the pain perception of patients after the SRP treatment which is one of the most common tools measuring pain used in many previous studies not only in periodontal treatment but also in other branches of dentistry ,19,28,31The patients used the VAS questionnaire to mark their pain level at 2, 4, 8, 12, and 48 h after the treatment. It is obvious that pain would be intense at the nearest hours after the treatment and would gradually decrease. The outcome of the study also showed the same, where after two hours the mean pain score was 0.88 and decreased to 0.13 after 48 h. A similar report was also observed in the previous studies irrespective of the time point of assessing the pain ,31. ThisThe current study measured the BOP, CAL, and PD as a routine radiographic examination of the periodontal treatment. CAL and PD are used to identify the classification of periodontal stages and grades. Moreover, BOP is a good indicator of active periodontal disease . This stThe limitation of the current study regarding the sample size calculation is that all the patients were included as a convenient sampling method. However, a proper sample size calculation would have provided a precise outcome. Moreover, the age range of the included patients was extensive. A specific age range could provide an improved outcome for this study. Therefore, further studies with enlarged samples and specific age ranges should be conducted.Analgesic consumption and anxiety levels are significantly associated with pain perception after SRP treatment.


F = 6.52, P = .003), PDAS , European quality of life 5-dimensions 5-level , and BDI  exhibited significant changes (P < .05), confirmed by pairwise t test, revealing a moderate to large effect size. From post-treatment to follow-up, all scores showed no significant changes (P > .1). In the qualitative study, the analysis revealed 3 subthemes: “Autonomy,” “Understanding of yourself and pain,” and “Acceptance of pain.” Our study suggests that integrated CBT may reduce the scores of PCS, PDAS and BDI, and this effect lasts for at least 1 year. Identified themes support the relevance of mitigative factors in managing chronic pain.Cognitive behavioral therapy (CBT) is known to improve chronic pain management. However, past studies revealed only small to moderate benefits in short-term results, and long-term follow-up studies are lacking. This study aimed to follow an integrated CBT program’s effectiveness 1.5 years after its completion. This observational study was the follow-up on the data collected from our CBT sessions conducted under 3 different studies in 2018 to 2019. Seven assessment items  were statistically analyzed. Thematic analysis was conducted in semi structured interviews. PCS ( Furthermore, many cases develop to be intractable and drug-resistant, and they are associated with persistent or recurrent disability; as a result, societal costs remain very high. There is a vast and imminent need for non-pharmacological, interdisciplinary therapy. Cognitive behavioral therapy (CBT) is considered especially important in the treatment of chronic pain.Global reports indicate that chronic pain  affects an estimated 10% to 15% of the population, and this is increasing every year. Regarding the long-term outcome in the meta-analysis, 15 studies with 1674 participants provided data on the effects of CBT on pain at follow-ups at 6 months or more. Longer-term results are not well reported in the literature, and we observed only 6 related studies published after 2020.–9 These studies revealed that the improvements caused by CBT were generally maintained well after 1 year. This discrepancy between small benefits in short-term results and a high level of continuance after 1 year may indicate that there are variants that work after CBT sessions. To resolve this, we conducted qualitative research to analyze patients who finished CBT sessions.However, the most recent meta-analyses indicated only small to moderate benefits in short-term results after CBT sessions. However, the study focused on the perspectives of professional stakeholders, who were offering a stepped-care approach for patients with chronic pain.Moreover, there are limited qualitative studies on the effects of CBT. There is only 1 published paper upon searching the queries’ chronic pain’, “CBT,” “qualitative study,” and the ’long term’.,12 and to illuminate the change in patients’ perspectives through qualitative research. In the single-arm trial and randomized control trial (RCT), patients who underwent our newly integrated CBT program for chronic pain exhibited statistically significant improvement with catastrophic cognition. The RCT delivered by videoconferencing suggested that the integrated CBT may reduce pain interference but not pain intensity. We hypothesize that previously reported results are maintained or improved along with the patients’ living, whose cognition is positively converted.The present study aims to substantiate the long-term results of two of our previous studiesThis longitudinal cohort observational study followed up the data performed by our CBT sessions, conducted as 3 different studies: a prospective open-labeled single-arm trial, an RCT, and a trial with treatment as usual participants from the randomized trial who received rescue CBT treatment.,12 The final CBT sessions for each study finished in 2018, 2019, and 2019, respectively. A total of 41 patients completed the sessions, and they were assessed to be eligible for this study.The first study was in-person CBT, and the second and third were video conference-based CBT. In these sessions, attention-shift training, memory work based on the peak-end rule, sharpening behavioral image training, and video feedback were operated in addition to Conventional CBT programs for chronic pain .Patients were recruited by postal announcements and telephone calls. Participants received packages inside which there were psychological tests and explanation of the study. Next, they were called to confirm their consent, and if they agreed, they joined the study. Then, patients answered psychological tests and sent them back to us. At the same time, they were interviewed by phone, with the duration of about 30 minutes.Interviews were recorded, and thematic analyses were performed using MAXQDA.This study was conducted under the approval of the Research Review Ethic Committee of Chiba University (no. 3899).Those who wished to participate in the study were informed of its purpose in the postal announcement confirming their willingness. Each patient was notified that participation was voluntary and complete anonymity was provided. They were asked to provide written informed consent. Adverse events included any unfavorable and unintended sign, symptom, or disease temporarily associated with this study, regardless of its relation. All adverse events were reported, and serious adverse events were immediately reported to the Institutional Review Board of Chiba University Hospital and registered with the hospital risk management system.Seven assessment items  were set based on the standard in “Assessment of Chronic Pain” recommended by the International Pain Society.NRS is a self-rated questionnaire that measures pain intensity on a scale of 0 to 10, where 0 = nothing and 10 = severe. For NRS, patients were asked to keep a daily pain diary.Catastrophizing one’s perception of pain was measured using the PCS. The degree of life disability due to pain was measured using PDAS. Depressive symptoms were assessed with PHQ-9 and BDI-II. GAD-7 is for screening and measuring the severity of generalized anxiety disorder. EQ-5D-5L is a widely applied, valid, and reliable measure of quality of life.t test. Cohen’s d of the change for each variable was collected. All P values were 2-sided, and the significance level was set to .05. Pairwise t tests were conducted post hoc.Patients were evaluated at week 1 , week 16 (Post-session), and a follow-up 1-year post-session (FU). For the primary analysis of comparing treatment effects, the means of the least squares and their 95% CIs were estimated by ANCOVA, with the change in the NRS baseline score. ANCOVA model accounted for the variation caused by gender and baseline scores of NRS. For statistical analyses of FU results, a total of 22 patients were compared pre-intervention versus follow-up-intervention. All analyses were performed using JMP 15 PRO, and a 2-tailed alpha level of 0.05 was used to define statistical significance. To assess the long-term effectiveness of CBT on pain, mean total scores at 3 assessment points for all outcomes were analyzed with single-factor (time) repeated measures analysis of variance (ANOVA). Then, 95% CIs were estimated and tested for significant differences by In the first part of the interview, participants were asked about their understanding and benefits of the treatment. The second part explored changes in patients. In the third part, patients were asked about their overall impressions of the treatment.All interviews were conducted by a phone call by the first author (K.T.), a registered psychiatrist. Patients were aware of the professional background of the interviewer. Interviews were audio-recorded. was conducted using MAXQDA to manage and organize the data.Thematic analysisIn addition to the priori codes and the semi structured interview, 9 codes were identified by an inductive approach. Each recording was listened to several times to establish familiarity. Quotations were extracted to illustrate subthemes. Both positive and negative examples of (sub)themes were coded for and integrated into the analysis during this process. Validity was established through the constant comparative method whereby recordings were repeatedly reviewed to ensure that (sub)themes correspond to the data. The first author undertook this process.Consolidated criteria for reporting qualitative research were used to double-check the research team’s essential aspects, study methods, study context, findings, analysis, and interpretations.The sample included 6 men (27%) and 16 women (73%), with a mean age of 50.91 years old (SD = 13.57 years). Participants had chronic pain  of longstanding duration , –8.00 PCS , –7.59 for PDAS , –0.77 for PHQ-9 , −0.73 for GAD-7 , 0.06 for EQ-5D-5L , and −4.93 for BDI . PCS, PDAS, and BDI exhibited significant changes with a moderate to large effect sizes. Next, where repeated measures ANOVA indicated significant changes, pairwise t tests were conducted post hoc (Table P < .025).ANOVA results regarding the long-term effectiveness of CBT showed significant improvement in participant symptoms. Changes in total mean scores from pretreatment to follow-up assessment were –0.82 for NRS . Notably, though conceiving that their pain had not been mitigated, all patients evaluated CBT as a helpful treatment; moreover, they were likely to recommend it to other patients.Theme 1-1: Helpful ContentsOpinions varied in the evaluation, of which contents were helpful or acquired as routine. The most popular ranges on the CBT menu were not indicated. In contrast, many participants emphasized that there was a time during each session when they felt it was counseling and not treatment, which brought a sense of ease.Many participants described the positive contribution of interactions with therapists.Thema 1-2: Useless ContentsParticipants reported a few contents that were hard to incorporate into daily life, even though they understood the benefits. Meditation and mindfulness are challenging to practice when pain is affecting participants. It was sometimes emotionally challenging for participants to evaluate pain or look back on the history of their pain, as this itself caused pain.Theme 2: Effect of CBTThis theme reflects physical or mental change after CBT practice and gradual transition after 1 to 2 years.Thema 2-1: AutonomyCBT sessions inspire patients to have competence in managing their pain. Before and even after CBT, participants barely attribute pain to psychologic only. However, CBT suggested that psychological conditions affected physical discomfort and, therefore, were manageable to a certain extent. Even though participants do not think all the pain is manageable, fostering a sense of autonomy leads to physical activity increase.Patient 19“I was only thinking about getting someone to do something or having something like the hospital or medicine have some effect to get the pain intensity down to zero, but then I was taught CBT, and this showed me how to control the pain mentally, so...I had to do it... yeah. “2-2: Understanding pain and oneselfCBT has an education program explaining how pain functions and is perceived. Participants confidently described psychoeducation as effective in relieving their anxieties and stopping ruminating.Patient 8“It became easier now that I understand the nature of pain. I always knew that chronic pain was painful, but I was told that this is what causes it and that it would be better to avoid it this way, so even if I could not avoid it 100%, it has become easier. I guess you would say I now know how to deal with it (the pain).”Thema 2-3: Acceptance of painAcceptance of pain was the most predominantly mentioned component among the participants. They conceived that their pain would not become 0, so they gradually decided that they should coexist with the pain. In contrast, reference to positive emotions towards medication was infrequent—the loss of expectation for the successful effects of medication is likely to be one of the reasons underlying the acceptance of pain. Participants used the terms “gave up” and “abandoned,” but there is a slight difference between the acceptance of pain and desperation. One of the keys might be to lower one’s self-demand and adjust to the possible range. Nevertheless, further research on this is necessary.Patient 15“I have come to think that I can live a normal life even if I am in some pain... In terms of taking the pain away, I think that having some pain is ok...I can live with that.....”Patient 3“It’s troublesome to be alive; they say there’s no way to fix the pain, and it won’t go away.”Integrated findingsAll the patients who participated in this study mentioned their satisfaction and expectations for CBT, even though their pain still existed or was even more challenging. However, this may not be applicable to the patients who did not participate Fig. .This is the first study to combine quantitative and qualitative studies on the long-term effects of CBT on chronic pain. Despite some limitations, the findings of this study indicate that the effects of adjunctive CBT seemed to impact measures of PCS, PDAS, and BDI and are well maintained 1 year after completion of treatment. There are patients who showed a change in their perspectives by gaining autonomy, understanding pain and oneself, and accepting pain. Not all of such patients had experienced mitigation of pain, but these changes in perspective may be the reasons for the decrease in PCS, PDAS and BDI scores. though currently only a few studies have investigated CBT.–19 Thirdly, the interviews were all conducted by telephone, as all participants chose this method over all other communication methods, including the internet . This may indicate the relation between internet literacy and the disease rate of chronic pain. If all the interventions of CBT were to be restricted to the internet, then this may result in the potential failure to reach out to participants who need help.Firstly, one of the strengths of this study is that we conducted a relatively long-term follow-up. Secondly, our study is an integration of quantitative research and qualitative analysis. Mixed methods research is becoming a vital methodology for complex health-related topics, providing new insights,The identified (sub)themes consist of 2 elements: acceptance by education and acquisition of self-efficacy, which both back up former research.Integrated findings show that patients summarized their impressions of therapy as positive, regardless of whether their pain improved or worsened Fig. . There wThis study has several limitations. The main limitations are that most patients who agreed to participate in this study already had a favorable opinion of CBT. There may be patients against CBT but did not answer the proposals of this continued study (14 of the 40 patients that we approached). Therefore, there is a possibility that our results have a selection bias.saturation is an unhelpful, unachievable concept. To replace the idea, there should be a focus on obtaining rich personal accounts and describing the similarities and differences in experiences among participants.Secondly, the sample size is relatively small, and CBT and videoconference-delivered CBT are mixed. The qualitative study had not reached the point of saturation. However, the small sample size is not a weakness of qualitative research but rather a core characteristic of many qualitative methodologies; data are intended to provide rich and deep exploration rather than broad surveys of phenomena. Moreover,  Therefore, concurrently with further research, it is necessary to construct systems for disseminating CBT, especially videoconference-delivered CBT.Despite the limited effectiveness of CBT, according to meta-analyses, CBT remains one of the only last resorts for ameliorating intractable chronic pain. However, efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia.We express our gratitude and respect for the dedication and contribution of the research participants. We thank our secretary Megumi Murase for her huge support. We thank the English Academic Service at Chiba University for the English editing discussion.Conceptualization: Kanako Tsubaki, Eiji Shimizu.Data curation: Kanako Tsubaki, Eiji Shimizu.Formal analysis: Kanako Tsubaki, Eiji Shimizu.Funding acquisition: Kanako Tsubaki.Investigation: Kanako Tsubaki, Kayoko Taguchi, Tokiko Yoshida, Rieko Takanashi, Eiji Shimizu.Methodology: Kanako Tsubaki, Eiji Shimizu.Project administration: Kanako Tsubaki, Eiji Shimizu.Resources: Tokiko Yoshida, Rieko Takanashi.Supervision: Eiji Shimizu.Validation: Kanako Tsubaki, Rieko Takanashi, Eiji Shimizu.Visualization: Kanako Tsubaki.Writing – original draft: Kanako Tsubaki.Writing – review & editing: Kanako Tsubaki, Kayoko Taguchi, Tokiko Yoshida, Rieko Takanashi, Eiji Shimizu.


Lumbar spine fusion (LSF) surgery is a viable form of treatment for several spinal disorders. Treatment effects are preferably to be endorsed in real-life settings.This prospective study evaluated the 10-year outcomes of LSF. A population-based series of elective LSFs performed at 2 spine centers between January 2008 and June 2012 were enrolled. Surgeries for tumor, acute fracture, or infection, neuromuscular scoliosis, or postoperative conditions were excluded. The following patient-reported outcome measures (PROMs) were collected at baseline, and 1, 2, 5, and 10 years postsurgery: VAS for back and leg pain, ODI, SF-36. Longitudinal measures of PROMs were analyzed using mixed-effects models.A total of 683 patients met the inclusion criteria, and 630 (92%) of them completed baseline and at least 1 follow-up PROMs, and they constituted the study population. Mean age was 61 (SD 12) years, 69% women. According to surgical indication, patients were stratified into degenerative spondylolisthesis , spinal stenosis , isthmic spondylolisthesis , degenerative disc disease , and deformity .All diagnostic cohorts demonstrated significant improvement at 1 year, followed by a partial loss of benefits by 10 years. ODI baselines and changes at 1 and 10 years were: (DS) 45, −21, and −14; (SS) 51, −24, and −13; (IS) 41, −24, and −20; (DDD) 50, −20, and −20; and (DF) 50, −21, and −16, respectively. Comparable patterns were seen in pain scores. Significant HRQoL achievements were recorded in all cohorts, greatest in physical domains, but also substantial in mental aspects of HRQoL.Benefits of LSF were partially lost but still meaningful at 10 years of surgery. Long-term benefits seemed milder with degenerative conditions, reflecting the progress of the ongoing spinal degeneration. Benefits were most overt in pain and physical function measures. Lumbar spine fusion (LSF) surgery is an established method in the treatment of several spinal disorders. Its short-term efficacy has been demonstrated in various populations and distinct pathologies Effects of LSF predominantly consist of pain relief and functional gain resulting in improving health-related quality of life (HRQoL). It has been stated that LSF may grant short-term benefits at the expense of late-term consequences Most long-term reports of LSF focus on select pathologies or compare treatment modalities In this study, we sought to scrutinize the 10-year outcomes of LSF on pain, disability, and HRQoL across different indications for elective fusion surgery. We hypothesized that the previously reported early benefits of LSF were substantially maintained at a longer follow-up.This study is based on a series of elective LSF surgeries performed in 2 Finnish spine centers  between January 2008 and June 2012. These public hospitals represent an academic institution and a big central hospital, covering both urban and rural communities of 775,000 inhabitants. Due to Finland's national healthcare insurance system, at the data collecting period, all LSF surgeries for this population were performed in these centers. As a result, the study population also features a population-based sample of elective LSF surgeries.At the outpatient clinic following decision on elective LSF, patients were offered enrollment in a prospective follow-up study. The attending surgeon procured a written, informed consent. Patients with tumor, acute fracture, or infection, neuromuscular scoliosis, and postoperative condition as an indication for surgery were not included.The surgeon recorded surgical indications and, accordingly, classified patients into degenerative spondylolisthesis (DS), spinal stenosis (SS), isthmic spondylolisthesis (IS), degenerative disc disease (DDD), and deformity (DF). Spinal stenosis and DS cohorts feature spinal stenosis, DS with and SS without DS. Degenerative disc disease patients typically feature severe disc degeneration, frequently with disc bulging and radiculopathy yet without distinct stenosis in magnetic resonance imaging. The deformity cohort features spinal stenosis with degenerative scoliosis, kyphosis, or lateral spondylolisthesis.Study setting had no interference to surgeries which were carried out according to standard clinical practice. Indications for surgery were similar across both centers. All surgeries were performed by 7 surgeons with experience of 5 to over 10 years in spine surgery. Also, all surgeons had operated together to ensure uniformity of procedures within and between centers. All surgeries were performed through open, posterior midline incision using pedicle screws. Open decompression was always performed in the presence of stenosis. Interbody spacers were used at the surgeons’ discretion. Ethical boards of both study centers had approved the study.Treatment effect was evaluated using established patient-reported outcome measures (PROMs). Pain intensity was quantified with visual analogue scale (VAS) (0–100 mm) for back and leg (radicular) pain. Back-related disability was determined using the Finnish validated version 2.0 of the Oswestry Disability Index (ODI) Data are presented as means with standard deviations (SD), medians with interquartile ranges (IQR), or frequencies with percentages. Differences in baseline demographical and clinical data across surgical indications (groups) were compared with one-way ANOVA, Kruskal–Wallis test, chi-square based test, or Fisher-Freeman exact test, as appropriate. Longitudinal measures of PROMs were analyzed using mixed-effects models with an unstructured covariance structure . We consider fixed effects to include indication for surgery, time, and indication for surgery * time interactions. As the use of mixed models allows for analysis of unbalanced  datasets without imputation, we analyzed all available data, using the full analysis set. Normal distributions were evaluated graphically, and with the Shapiro–Wilk W test. All analyses were performed with Stata 17.0 (StataCorp LP).During the data collecting period, 795 LSFs were performed in the 2 study centers. Before surgery, only 10 patients declined to participate. A total of 683 patients met the inclusion criteria . Of thosAccording to surgical indication, patients distributed as follows: DS: ; SS: ; IS ; DDD ; and DF . Hence, 434 (69%) patients encompassed spinal stenosis (DS + SS). DDD and IS patients were younger and better educated compared to other cohorts. Patients with DS, IS, and DDD most often received short fusions (1-2 levels), whereas SS (without spondylolisthesis), and deformities ensued longer fusions pertaining to wider-ranging pathology. Rate of interbody spacer was highest within IS cohort.All diagnostic cohorts demonstrated significant decrease in ODI after surgery , followeAligned improvements in VAS for back and leg pain  Long-term pain score trajectories are reported more sporadically than ODI. With various indications, long-term reduction in back pain of −2.0 to −3.7  and leg pain of −2.3 to −3.3 have been reported Measuring HRQoL on par with pain and disability is preferred in outcomes studies A population-based sample, validated outcome instruments, continuity of follow-up, and logical results are the strengths of this study. The 10-year response rate of 74% constitutes a limitation typical to long-term studies Another limitation of this study is the lack of control cohort treated without surgery. Nevertheless, as the natural course of distinguished spinal stenosis is not favorable, In the light of above limitations, our results best serve as a real-life evidence of long-term effects of elective LSF surgeries. It is valuable to see aligned while not similar benefits across the spectrum of LSF surgeries. Moreover, benefits were visible still at 10 years despite the fact that a significant share of patients have undergone reoperations by then In the present study, patients undergoing elective LSF surgeries were enrolled to a prospective 10-year follow-up. Benefits of LSF on pain, disability, and HRQoL were partially lost but still meaningful at 10 years of surgery. Magnitude and longevity of benefits showed slightly varying trends across surgical indications, although benefits were demonstrated in all diagnostic groups.One or more of the authors declare financial or professional relationships on ICMJE-NASSJ disclosure forms.


Dear Editor, We are writing to discuss the paper entitled Patient-Reported Utilization Patterns of Fentanyl Transdermal System and Oxycodone Hydrochloride Controlled-Release Among Patients With Chronic Nonmalignant Pain' in the May/June 2003 issue of the Journal of Managed Care Pharmacy. We credit the authors in their task of collecting information on chronic pain patients via survey method, as this type of study in chronic nonmalignant pain patients has never been conducted. The results, although intriguing, were based on a single survey with no follow-up survey assessments. It is interesting to note that the only values that were significant in the multivariate analyses were gender  and duration on medication . We have several questions and comments that we would like the authors to address in order to provide the readers with a more complete understanding of the


Background and Aim: Postoperative pain after scoliosis surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options, such as wound infiltration, are limited and include neuraxial analgesia. However, they are rarely used due to side effects and inconsistent efficacy. We report an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks. This case series evaluated the analgesic effect of the bilateral bi-level erector spinae plane blocks (ESP) in congenital and neurogenic scoliosis surgery. Patients and Methods: Six pediatric patients with congenital or neurogenic scoliosis underwent posterior spinal fusion involving 5 to 12 vertebral levels. Bilateral single-injection ESPB was performed at one or two levels before incision. Preoperatively, patients received intravenous dexamethasone. General anesthesia with endotracheal intubation and volume-controlled ventilation was performed via TIVA with remifentanil and propofol. During and after the procedure, the basic hemodynamic parameters, opioid consumption, pain scores , and possible block complications were monitored. Results: All the patients experienced minimal postoperative pain levels. In addition, on the first day after surgery, they had low opioid requirements with no side effects. Conclusions: ESPB in patients undergoing congenital and neurogenic scoliosis correction surgery seems to be an essential analgesic technique that may reduce both severities of pain and opioid consumption. Posterior spinal fusion for scoliosis correction is an excruciating surgery and usually requires long-term, high-dose opioid use for adequate perioperative analgesia . NeuromoWe aimed to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring with ESPB. The benefits of this approach are illustrated in six pediatric patients undergoing congenital or neurogenic scoliosis correction.Written informed consent was obtained from the parents/caregivers of the patients for this scientific contribution.Six pediatric patients with congenital or neurogenic scoliosis underwent posterior spinal fusion involving 5 to 12 vertebral levels. The patients were American Society of Anesthesiology classes 1–3.2/Air 40:60) was induced and maintained using IV infusions of propofol 80–130 mcg/kg/min, remifentanil 0.05–0.1 mcg/kg/min, titrated to achieve hemodynamic stability monitored through radial artery line, and adequate anesthetic depth  values between 45–65. In addition, the combination of intraoperative 15 mg/kg acetaminophen, 15 mg/kg metamizole, and 10 mg/kg ibuprofen was applied as a multimodal analgesia protocol in the opioid-sparing anesthetic regimen.An hour before the surgery, dexamethasone was administered intravenously (IV) at 8 mg. In addition, all patients received 7.5 mg midazolam p.o. thirty minutes before surgery. General anesthesia with endotracheal intubation and volume-controlled ventilation , and the time of the surgery were monitored.Postoperative analgesia consisted of intravenous acetaminophen 15 mg/kg 6-h, 15 mg/kg metamizole 6-h, and 10 mg/kg mg ibuprofen 6-hourly administered at the same time to prevent rebound pain. In addition, the bolus of 25 μg/kg morphine sulfate and then an infusion of 10 μg/kg/h morphine sulfate was administered for rescue analgesia if the NRS score was higher than 4.After the procedure, the basic hemodynamic parameters, opioid consumption, and NRS pain scores were monitored. During the stay at the ICU, the postoperative NRS score was observed at 0, 2, 6, 10, 14, 18, 24, and 48 h. The NRS scores were monitored daily from the second postoperative day in the pediatric orthopedic ward. In addition, possible block complications were observed.Six patients: one boy and five girls, aged 11–16 (mean 12 +/−2) years old, weight 26–68 (mean 51.7 +/−15.9) kg, height 130–160 (mean 152.9 +/−15.9) cm. The patients’ ASA class was 103, including one with no comorbidities, two obese children with mild restriction in spirometry, one with surgically treated ASD , one with Rett syndrome and asthma, and one with cerebral palsy. All patients underwent posterior spinal fusion due to congenital kyphoscoliosis in four patients and neurotic kyphoscoliosis in two patients. In addition, five patients received single-shot bilateral, bi-level ESP blocks, and one patient received single-shot bilateral, one-level ESP blocks, as seen in The hemodynamic status of all patients was carefully monitored and stabilized throughout surgical incision, dissection, and retraction of dorsal muscles, insertion of pedicle screws, and ventricle connecting rods. After the ESP block, the SSEPs  were monitored during all surgical procedures. No SSEP change from baseline was observed. During operation, SSEP amplitude decreased by no more than 50%, and latency increased by 10%.Opioid and propofol consumption: The total requirements of remifentanil and propofol are listed in The basic hemodynamic parameters were stable in the normal range. Patients were asked to rate perceived pain at all postoperative time points using the 11-point NRS (0 indicating no pain and 10 indicating the worst pain imaginable) at 0, 2, 6, 10, 14, 18, 24, 48, 72, 96, and >96 h. The evaluation was performed during the child’s examination by two independent physicians, who encouraged the patients to describe the pain intensity numerically at certain stages of observation, as shown in The total opioid consumption varied between 0.11 and 0.69 (0.44 +/−0.23) IV hydromorphone milligram equivalents/kg in the ICU, 0.25 and 1.11 (0.6 +/−0.34) IV hydromorphone milligram equivalents/kg in the first 24 h, 0.19 and 1.11 (0.43 +/−0.34) IV hydromorphone milligram equivalents/kg in the second 24 h, 0.08 and 0.42 (0.29 +/−0.12) IV hydromorphone milligram equivalents/kg in the third 24 h, 0 and 0.29 (0.13 +/−0.15) IV hydromorphone milligram equivalents/kg in the fourth 24 h. Patients did not require opioids on the fifth day after surgery, as in There were no complications related to the nerve block.All patients were discharged home on day 5 or 6 after surgery.Most existing studies concern pain treatment following idiopathic scoliosis surgery. It is hard to make conclusions based only on idiopathic scoliosis treatment. Patients undergoing posterior spinal fusion for correction of idiopathic scoliosis require intravenously administered opioids for the first 36 h and report moderate-to-severe pain in the days following surgery ,14. AlsoNeurophysiological monitoring of spinal integrity is essential for the safety of scoliosis surgery.Physical signs of paravertebral epidural diffusion of local anesthetic have been reported with ESPB ,26, but Neurophysiological monitoring of spinal integrity of motor evoked potential (MEP) and somatosensory evoked potentials (SSEPs) is essential for the safety of scoliosis surgery ,29. AnesSimilar to other studies, hypotension associated with local anesthetic sympathectomy was not reported . TherefoWe performed the ESP blocks after anesthetic induction and prone position. This slightly risks the procedure but is acceptable in young and highly anxious patients. Preoperative performance requires using a single injection block rather than a sequential technique. We chose not to place a catheter surgically at the time of wound closure to minimize the uncertainty regarding the adequacy of the craniocaudal spread in the currently disrupted tissue plane and the complexity of the postoperative analgesic regimen. Studies in other patient populations have shown that a single injection of ESP block provides effective pain relief for at least 8–12 h ,34. ThisThe main limitation of this study is the sample size and the heterogeneity of the sample size. However, due to the limited number of studies concerning pain management following neurogenic and congenital scoliosis surgery, we decided to describe ESPB as an analgesic strategy for corrective scoliosis surgery.ESPB in patients undergoing congenital and neurogenic scoliosis correction surgery seems to be an essential analgesic technique that may reduce both severities of pain and opioid consumption. Further studies, including randomized controlled trials, are warranted to confirm these preliminary observations and investigate whether the strategy provides similar opioid-sparing analgesia in other types of spine surgery in pediatric patients.


In the phase 3 ALSYMPCA study, 223Ra prolonged survival and improved quality of life versus placebo. Our real-world study, PARABO, investigated pain and bone pain–related quality of life in patients with mCRPC and symptomatic bone metastases receiving 223Ra in clinical practice. Methods: PARABO was a prospective, observational, noninterventional single-arm study conducted in nuclear medicine centers across Germany (NCT02398526). The primary endpoint was a clinically meaningful pain response (≥2-point improvement from baseline for the worst-pain item score in the Brief Pain Inventory–Short Form). Results: The analysis included 354 patients, who received a median of 6 223Ra injections . Sixty-seven percent (236/354) received 5–6 injections, and 33% (118/354) received 1–4 injections. Of 216 patients with a baseline worst-pain score of more than 1, 59% (128) had a clinically meaningful pain response during treatment. Corresponding rates were 67%  with 5–6 223Ra injections versus 43%  with 1–4 injections, 60%  in patients with no more than 20 lesions versus 59%  in those with more than 20 lesions, and 65%  in patients without prior or concomitant opioid use versus 54%  in those with prior or concomitant opioid use. Mean subscale scores (pain severity and pain interference) on the Brief Pain Inventory–Short Form improved during treatment. Conclusion:223Ra reduced pain in patients with mCRPC and symptomatic bone metastases, particularly in patients who received 5–6 injections. The extent of metastatic disease did not impact pain response. Most patients with advanced prostate cancer develop bone metastases . The forCurrently, pharmacologic management of bone pain in patients with bone metastases involves mainly nonsteroidal antiinflammatory drugs and opioid analgesics used with different adjuvant therapies , accordi223Ra-dichloride (223Ra) is an α-particle–emitting radiopharmaceutical approved for the treatment of patients with bone-dominant metastatic castration-resistant prostate cancer (mCRPC), based on the registrational phase 3 ALSYMPCA study  and the time to the first symptomatic skeletal event (SSE)  versus placebo, when each was used in combination with the standard of care  was designed to investigate the effect of 223Ra across nuclear medicine centers in Germany. The study design is depicted in Supplemental Figure 1 . Eligible male patients had a diagnosis of mCRPC with symptomatic bone metastases and no known visceral metastases. Treatment with 223Ra was initiated as per each investigator’s routine clinical practice. Patients participating in an investigational program with interventions outside routine clinical practice or participating in another observational study with 223Ra were excluded. Documented approval from appropriate independent ethics committees or institutional review boards was obtained for all participating sites before the study. All patients provided written informed consent before study participation.PARABO was an observational, prospective single-arm cohort study designed to assess pain and bone pain–related QoL in patients with mCRPC receiving 223Ra was administered at a 55-kBq (1.485 μCi)/kg dose by intravenous injection every 4 wk, up to a maximum of 6 injections.223Ra treatment, pain control and progression rates, time to first pain progression, time to first opioid use, covariates of pain response during treatment, pain response based on extent of bone metastases at baseline, OS, treatment-emergent adverse events, number of fractures, and time to first SSE. QoL was assessed using a questionnaire: Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain. All secondary endpoints are detailed in the supplemental methods.The primary endpoint was a clinically meaningful pain response, defined as an improvement by at least 2 points from baseline in the worst-pain item of the Brief Pain Inventory–Short Form at any postbaseline assessment. Secondary endpoints included change in pain- and bone pain–related QoL over time during Investigators collected historical data  from medical records. Treatment-related data, the results of tumor assessments, and other disease status information were collected during routine practice visits. For patient-reported outcomes, questionnaires were completed by patients during routine visits.For sample size calculation, the precision of the estimate for the primary outcome (pain response rate) was considered. Precision was defined by the width of the 95% CI of the estimate with a given sample size. A precision of less than 20% was considered clinically meaningful, taking the variance of pain measurements into account. Assuming that at least 60% of patients would be evaluable for the primary analysis of pain response at a postbaseline assessment and that 30%–70% of these evaluable patients would show a pain response, at least 350 patients would be required to achieve a precision of less than 20%. Sample size calculations were performed with the nQuery 7 (Statsols) platform. Statistical analyses in this study were primarily of an explorative and descriptive nature.223Ra. Two patients who did not meet all eligibility criteria were excluded; thus, 354 patients were included in the full analysis set. Patient enrollment, treatment, and eligibility are shown in Supplemental Figure 2. Patient baseline characteristics are given in Between March 2015 and December 2017, 358 patients were enrolled at 27 medical centers; 356 patients received at least 1 dose of 223Ra injections are shown in Supplemental Table 1. Among patients with an Eastern Cooperative Oncology Group performance status of 2–4, a superscan, opioid use , an alkaline phosphatase (ALP) level of more than 300 U/L, a prostate-specific antigen (PSA) level of more than 200 μg/L, or at least 3 prior systemic anticancer therapies, a greater proportion received 1–4 than 5–6 injections .Baseline characteristics for patients who received 1–4 or 5–6 223Ra injections received was 6 ; 33% (118/354) of patients received 1–4 injections, and 67% (236/354) received 5–6 injections . 223Ra treatment was delayed or interrupted in 6% (23/354) of patients, most often for adverse events . Adverse events were also the most common reason for 223Ra discontinuation (12%), followed by progression of underlying disease (10%), the patient’s decision (8%), and death (6%).The median number of 223Ra injections was greatest for patients who received concomitant enzalutamide and lowest for patients with a higher number of bone metastases, higher baseline ALP or PSA levels, opioid use, or prior chemotherapy . The percentage of patients with blood cell counts below the limit for further injections at each treatment visit is shown in Supplemental Table 4. The median time from castration resistance to the first 223Ra injection was 10 mo   in those who received 5–6 injections .The likelihood of receiving a higher number of –155 mo) . The med223Ra injections, 1.2-fold greater in patients without than with prior or concomitant opioid use, and generally similar regardless of lesion number  of evaluable patients overall. Among the individual subgroups assessed, rates of clinically meaningful pain response were 1.6-fold greater in patients who received 5–6 than 1–4 n number .When the effects of covariates on this pain response were assessed, greater rates of pain response were seen at most treatment visits in patients with a baseline ALP of more than 300 U/L than in those with less than 150 or 150 − 300 U/L , patients with baseline PSA of less than 50 or 50–200 μg/L than in those with more than 200 μg/L , and patients who were taking nonopioid analgesics or weak opioids than those taking strong opioids . No other covariates had consistent effects on response rates, including the number of known bone metastases at baseline or prior treatment with chemotherapy, abiraterone, enzalutamide, or bone health agents.223Ra treatment  reported complete or nearly complete (80%–100%) pain relief . The median time to the first opioid use in patients who had not received prior opioids was NR .The median time to the first pain progression was 6.70 mo ; the time to pain progression was shorter in patients treated with 1–4 than 5–6 At each study visit, the mean decrease from baseline in worst-pain scores was greater in patients with strong bone uptake than in those with weaker bone uptake . For all skeletal areas that were most frequently reported as hurting at baseline , fewer patients reported these areas as still hurting in the posttreatment follow-up period .223Ra injections than in those who received 1–4 injections .Median OS was 17.15 mo  in the total patient population and was longer in patients who received 5–6 jections . Median n = 4) and metastasis to soft tissue (n = 1).Any-grade treatment-emergent adverse events occurred in 56% (200/356) of patients, and serious treatment-emergent adverse events occurred in 27% (96/356) . The most common treatment-emergent adverse event and drug-related treatment-emergent adverse event was anemia , whereas few patients experienced pancytopenia (2% for each) or thrombocytopenia (2% for each) . Grade 5223Ra treatment and the 5-y follow-up. The most common of these events were new external-beam radiotherapy use and new symptomatic pathologic fractures  (New SSEs occurred in 15% (52/354) of patients during rtebral) . The med223Ra injections than 5–6 injections, although only the latter had nonoverlapping 95% CIs. Patients who used concomitant bone health agents had a lower incidence of pathologic fractures and a higher incidence of bone-associated events other than fractures than did patients who did not use concomitant bone health agents, although 95% CIs were overlapping in all cases .The incidence rate of pathologic fractures was 0.14  during the treatment period and 0.05  during the 5-y follow-up period. The incidence rate of nonpathologic fractures was not recorded during treatment. However, the incidence of nonpathologic fractures during the 5-y follow-up period was 0.01 . The incidence proportions of pathologic fractures and bone-associated events other than fractures are shown in Supplemental Table 11. The incidence proportions of pathologic fractures and bone-associated events other than fractures were higher in recipients of 1–4 223Ra in alleviating pain and improving bone pain–related QoL in patients with mCRPC and bone metastases in the current clinical landscape. PARABO was a large (354 patients) prospective study specifically designed to assess these outcomes in a heterogeneous real-world patient population, providing strong evidence on pain response during 223Ra treatment relative to the other available studies in this setting, which were mostly smaller, retrospective, or not designed primarily to evaluate pain   of patients experienced a clinically relevant reduction in pain during 47%–58%) –16 and c47%–58%)  conducte therapy .223Ra into the mCRPC treatment pathway continues to be an area of interest to ensure that patients receive as many life-prolonging therapies as possible. In our study, two thirds of patients received either no (32%) or 1 (34%) life-prolonging therapy before starting 223Ra therapy. However, the survival benefit of early- versus later-line 223Ra use in clinical practice is not yet clear from recent real-world studies. In the PRECISE study, slightly reduced risks of all-cause and prostate cancer–specific mortality were seen with 223Ra versus other mCRPC treatments, when used as a second- or third-/fourth-line treatment  than in ALSYMPCA 14.9 mo) ( mo (9). reatment , whereasline use .223Ra injections. These patients were more likely to achieve a clinically meaningful pain response and had longer OS than those who received 1–4 injections, as is consistent with the OS findings of other real-world studies .Like other real-world studies, our study had certain limitations, including the potential for suboptimal collaboration between urologists (the primary contacts for patients) and nuclear medicine physicians (involved later in the treatment course), which may affect the timeliness of 223Ra in reducing pain  and improving bone pain–related QoL and OS. Completion of 5–6 223Ra injections was associated with the greatest benefit in these outcomes. 223Ra had an acceptable safety profile, consistent with that established in previous studies.This large, real-world study provided evidence supporting the effectiveness of Holger Palmedo received sponsorship from Bayer, GE, Rotop, Sanofi-Aventis, and Curium. Hojjat Ahmadzadehfar received fees for advice or lectures from Bayer, Advanced Accelerator Applications (AAA), and SIRTEX. Andreas Niesen received fees for advice or lectures from Bayer. Felix Mottaghy is a medical advisor for NanoMab Technology Ltd. and AAA GmbH and has recently received institutional grants from NanoMab Technology Ltd., Siemens, and GE Precision Health Care LLC, all outside the submitted work. Rongjin Guan is a contractor employee at Bayer. Per Sandström is an employees of Bayer. Joerg Pinkert is an employee and stockholder of Bayer AG. Ken Herrmann reports personal fees from Bayer, SIRTEX, Adacap, Curium, Endocyte, IPSEN, Siemens Healthineers, GE Healthcare, Amgen, Novartis, and Y-mAbs; personal fees and other fees from Sofie Biosciences; nonfinancial support from ABX; and grants and personal fees from BTG, all outside the submitted work. No other potential conflict of interest relevant to this article was reported.