It may be concluded that addition of ondansetron to paracetamol would not result in further postoperative pain reduction and additive use of this drug is not recommended.This study was performed to determine the comparative efficacy of paracetamol alone versus paracetamol plus ondansetron on acute postoperative pain after abdominal surgeries in Azad University hospitals in 2017 and 2019. In this randomized clinical trial, 62 consecutive patients under abdominal surgeries, were randomly divided into two groups, group 1 patient who received paracetamol alone 1 gram and group 2 patient who received paracetamol 1 gram plus 4 mg ondansetron and the pain severities were determined and compared between groups at recovery and after 4 and 24 hours. The results of this study revealed that there were no statistically significant differences between two groups for the postoperative pain severity and analgesic use ( Pain is one of the problems that always harms the person and has many unwanted side effects. According to the definition of the International Association for the Study of Pain (IASP), pain is an unpleasant emotional and sensory experience with potential or actual tissue damage.This study was a randomized clinical trial study in patients undergoing elective abdominal surgery. The inclusion criteria for this study were elective surgery, individual consent for participation in the study, no history of paracetamol and ondansetron susceptibility, age 20 to 60 years, body mass index (BMI) 20 to 30, tendency to general anesthesia, grade 1 and 2 American Society of Anesthesiologists (ASA), and no history of drug addiction. The exclusion criteria for this study were history of surgery for more than three hours, lack of patient collaboration due to postoperative delirium, complication of surgery, and use of postoperative supplements. After obtaining written consent from patients who underwent elective abdominal surgery and had ASA Classes 1 and 2, they were randomly divided into two groups: group 1: patient who received paracetamol alone 1 gram and group 2: patient who received paracetamol 1 gram plus 4 mg ondansetron. The patients were unaware regarding the type of intervention.In both groups after induction with fentanyl 2 µg/kg, midazolam 0.05 mg/kg, atracurium 0.5 mg/kg, each hour 0.5 to 1 µg/kg fentanyl and the patients were intubated using tracheal tube . To maintain anesthesia, oxygen and nitroxide were used in equal ratio (50% each) plus propofol 6 to 12 mg/kg/h. Each hour 0.001 mg/kg fentanyl and 0.2 mg/kg atracurium were administered to patients.At the end of the surgery, muscle relaxant drugs were reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. Extubation of tracheal tubes was taken after returning gag reflux to normal situation.It should be noted that in the first group, 1 gram of paracetamol was injected intravenously within 20 minutes for patients at the end of the operation. In the second group, ondansetron was given 4 mg and 30 minutes before the end of the intravenous operation, and at the end of the operation, 1 gram of paracetamol was injected intravenously and administered in 20 minutes to patients.Patients' pain was then assessed by a trained nurse at the time of recovery, 4 hours and 24 hours after the operation, and recorded in the questionnaire. Additionally, the opioid drug was recorded in the questionnaire within 24 hours of operation, and then the two groups were compared by statistical analysis. Collected data was evaluated using checklist and field survey. The clinician responsible for collecting the data was oblivious regarding the type of intervention till the end of the study.Data were analyzed using SPSS software version 13. For quantitative data, mean, and standard deviations were recorded. Absolute and relative frequency were recorded for qualitative variables. The tests were Chi-square, T-independent, and Fisher, and the level of significance was <0.05.T-test of two independent samples was used to evaluate the effect of adding ondansetron to paracetamol to improve postoperative pain. Power analysis was used to evaluate the adequacy of the sample size. Power analysis was performed using pwr package.This study was approved by the Research Ethics Committee Board at the  and was in accordance with the Helsinki principles.p-values were as follows:p = 0.872,p = 0.793,p = 0.855,p = 0.199, andp = 0.316, respectively).The distribution of age, gender, BMI, ASA class, and type of surgery were identical in two groups (p = 0.221).p = 0.839).There was no statistically significant difference between the two groups in the number of opioids administered intraoperatively (p = 0.653). This similarity is shown inp = 0.162), as is shown inp = 0.083), which is depicted inThe severity of pain at the time of recovery was similar in two groups (Nowadays, there are several treatments to reduce pain after surgery, each with its own effectiveness and success.The results of this study showed that the severity of postoperative pain in recovery and at 4 and 24 hours after surgery in patients did not differ significantly between patients receiving paracetamol alone and those who received paracetamol with ondansetron. Also, the number of opioid consumed during the operation and in the postoperative phase were similar in patients receiving paracetamol alone and those who received paracetamol with ondansetron. In an interventional study conducted by Bhosale et al in the United States,In another interventional study conducted by Alipour et al in Iran,In an experimental study conducted by Minville et al,In the second protocol, paracetamol 100 mg/kg plus saline, paracetamol 100 mg/kg with ondansetron 2 mg/kg or saline alone were injected into the peritoneum. It was observed that the reduction in pain intensity for paracetamol was significantly greater than ondansetron.In an interventional study conducted by Memis et al in Turkey,Based on the results of this study and their comparison with other studies conducted in this field, it is concluded that the addition of ondansetron to paracetamol has no more effect on reducing acute pain after abdominal surgery, so using it along with paracetamol is not recommended. At the end, it is recommended that further studies be conducted to confirm the findings of this study with a higher sample size and also to evaluate other methods of pain relief after surgery.


BackgroundHemorrhoids are a common condition that presents with bleeding per rectum, pain at rest and defecation, mucosal discharge, and prolapse. Surgical hemorrhoidectomy is the treatment method of choice for Grade 3 and Grade 4 hemorrhoids. Hemorrhoidectomy is associated with postoperative pain and no single surgical technique has been proved to significantly reduce the pain. We analyzed in our study the effect of lateral internal sphincterotomy with hemorrhoidectomy on postoperative pain, anorectal function, and retention of urine after the Milligan and Morgan technique.MethodsThis randomized, prospective, and comparative study included 200 Grade 3 and Grade 4 hemorrhoids patients who were scheduled for surgical management. The patients were classified randomly into two groups with an equal number of participants: Group A underwent Milligan & Morgan open hemorrhoidectomy and Group B underwent lateral internal sphincterotomy (LIS) in addition to Milligan and Morgan open hemorrhoidectomy. Postoperative pain was recorded using the Visual Analog Scale (VAS) score for up to 48 hours. Postoperative bleeding, urinary retention, and bowel and gas incontinence were noted. Long-term follow-up at six and 24 months for anal stenosis, anal fissure, incontinence, and recurrence was also noted.ResultsPatients who underwent LIS showed a significant reduction in postoperative pain at 12 hours (p=0.0008*), 24 hours (p=0.000*), and 48 hours (p=0.003*); the time taken to request rescue analgesia was similar between the two groups (p=0.07). Side effects, such as postoperative bleeding and urinary retention, were significantly lower after LIS , and gas incontinence was significantly higher after LIS (p=0.002*). The long-term outcomes of anal fissure were significantly higher without LIS at six months (p=0.02*) and 24 months (p=0.04*) and those of anal stenosis were significantly higher without LIS at six months (p=0.04*).ConclusionsFrom our study, we conclude that postoperative pain, bleeding, and urinary retention were significantly lower after LIS, and gas incontinence was transient. The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after LIS. However, bowel and gas incontinence and recurrence were not altered. Therefore, we conclude that the addition of LIS to hemorrhoidectomy improves patient outcomes in terms of postoperative pain and anorectal function. Hemorrhoids are formed by the downward displacement of dilated submucosal vascular anal cushions, commonly located at 3, 7, and 11 o'clock in the anal canal. It is a common condition which presents with complaints of bleeding per rectum, pain at rest and defecation, mucosal discharge, and prolapse. Surgical hemorrhoidectomy is the treatment method of choice for Grade 3 and Grade 4 hemorrhoids .The surgical techniques employed include the Milligan and Morgan technique, which is most commonly performed, the Ferguson technique, stapled hemorrhoidectomy, the technique using a harmonic scalpel or ligasure, and Doppler-guided hemorrhoidal artery ligation. The early complications after surgery include postoperative pain, primary hemorrhage, and retention of urine .Hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proved to significantly reduce the pain . The paiWe analyzed in our study the effect of lateral internal sphincterotomy with Milligan and Morgan hemorrhoidectomy on postoperative pain, anorectal function, and retention of urine.This randomized prospective comparative study was performed in ACS Medical College Hospital after obtaining institutional ethical committee clearance. The following patients were enrolled in the study: patients with clinical and investigatory support for the diagnosis and willingness for the surgical management of Grade 3 and 4 hemorrhoids. Any patient with the following was excluded from the study: inflammatory bowel disease, fissure, recurrent hemorrhoids, fistula, malignancy, cirrhosis, and portal hypertension, pregnancy, and age < 20 and > 60 years. All patients enrolled in the study were explained about the study procedure and their informed written consent was taken. The study comprised 200 patients of Grade 3 and 4 hemorrhoids who were randomly divided into two groups of 100 each, named Group A and Group B. In Group A, only Milligan and Morgan open hemorrhoidectomy was done, and in Group B, lateral internal sphincterotomy (LIS) was done in addition to Milligan and Morgan open hemorrhoidectomy.Preoperatively, patients in both groups were optimized. Patients in both groups were started on metronidazole therapy for five days, along with oral liquid paraffin. All patients in the study were prescribed local application of glycerine and magnesium sulfate soaked dressings to reduce edema and relieve pain. Patients were also advised to take a Sitz bath thrice a day and were taught to maintain proper anal hygiene. All patients were given an enema early morning on the day of surgery. Patients in both groups received spinal anesthesia.After spinal anesthesia, and after the optimal level of block was achieved, the patients were put in lithotomy position, parts painted, and draped. A per rectal examination and preliminary proctoscopy were done. The anal skin was held with Allis forceps and retracted first at the 7 o'clock position. The hemorrhoidal mass was visualized and held with artery forceps. A V-shaped incision was made at the skin from the anoderm up to the anal mucosa, followed by gentle dissection. The hemorrhoid mass was separated from the internal anal sphincter till the apex of the pedicle was reached. The hemorrhoid pedicle was ligated using vicryl (absorbable suture) and excised in toto. The bare area was left open. A similar procedure was repeated first at 3 o'clock position, and finally at the 11 o'clock position. Complete hemostasis was obtained. An anal pack was kept which was soaked in liquid paraffin and povidone-iodine.For those in Group B, in addition to the Milligan and Morgan technique, a lateral internal sphincterotomy was also done. Intersphincteric groove was palpated. A 1 cm lateral incision made at 3 o'clock position near the anal verge. Gentle dissection was done along the submucosa till the internal sphincter was reached. The lower free end of the internal sphincter was hooked out using artery forceps and divided. Complete hemostasis was obtained and the wound was left open. The intraoperative bleeding during the surgery was kept to a minimum using cautery and gentle dissection.Postoperatively, all the patients were kept nil per oral for six hours after surgery and later started on a liquid diet, followed by a soft, high-fiber diet. All the patients in Group A and Group B were routinely given injection paracetamol 1 g intravenously (IV) on the night of surgery. If the patients complained of pain prior to this, then injection tramadol 100 mg IV was given as rescue analgesia. The anal pack was removed in both groups after six hours postoperatively. The patients were also advised on the need for early ambulation and a sitz bath postoperatively to minimize the chances of infection.The primary objective of the study was pain relief after surgery in the postoperative period. The pain was assessed by using the Visual Analog Scale (VAS) at 12, 24, and 48 hours with a rating ranging from 0-10: 0 - no pain, 1-3 - mild pain, 4-6 - moderate pain, 7-10 - severe pain. The time taken for the first request of rescue analgesia was also noted. The secondary objective included postoperative complications. Factors taken into account included postoperative incidence of bleeding, urinary retention, and bowel and gas incontinence until 48 hours.The observation and data collection of bleeding was assessed subjectively into groups based on the amount of bleeding. They were grouped as: None - no bleeding; Confined - minimal loss/occasional episodes during defecation (<20 ml of blood); Moderate - frequent episodes during defecation (>20 ml of blood); Severe - persistent bleeding even without defecation with fall in hemoglobin levels (<10 g/dl requiring hematinics or <7 g/dl requiring blood transfusion).Both the groups were observed for the inability to void urine under voluntary control. For those who failed to void voluntarily, bladder catheterization was done. Percentage of patients who required bladder catheterization for urine drainage was noted. Incontinence was assessed by Wexner's incontinence score for solid, liquid, and gas. Short-term and long-term follow-ups were done at six and 24 months after surgery to rule out late complications like anal fissure, anal stenosis, bowel or gas incontinence, and recurrence.StatisticsData were analyzed using the Statistical Package for Social Sciences (SPSS); continuous variables were analyzed using unpaired t-test for two means, and categorical data were analyzed using Chi-square test. Data were expressed as mean±SD and as percentages where appropriate. P-value <0.05 was considered statistically significant.In the present study, both groups were comparable in terms of age, weight, sex, and grade of disease Table .The VAS score was assessed at 12 hours, 24 hours, and 48 hours postoperatively. The mean VAS score in Group A was 6.12 at 12 hours, 5.61 at 24 hours, and 4.04 at 48 hours. The Mean VAS score in Group B was 5.1 at 12 hours, 3.4 at 24 hours, and 3.2 at 48 hours. The VAS score was statistically significant at 12, 24, and 48 hours. The p-values were 0.0008* (12 hours), 0.000* (24 hours), 0.003* (48 hours)  Table . UrinaryFollow-up of our patients was done at six months. Of the 200 study patients, 186 patients were followed up: 92 in Group A and 94 in Group B. Five patients had an anal fissure and four had anal stenosis in Group A. In Group B, none had an anal fissure or anal stenosis. This was statistically significant with p=0.02* and 0.04*, respectively (Table A long-term follow-up at 24 months was done. Of the 200 patients, 158 patients were followed up: 81 in Group A and 77 in Group B. Four patients had an anal fissure in Group A and none in Group B, which was statistically significant p=0.04* (Table Postoperative pain after haemorrhoidectomy is attributed to high anal canal pressure due to increased tone of the internal sphincter. Eisenhammer was the first to discover that spasm of internal sphincter is responsible for post-haemorrhoidectomy pain . The hypKanellos et al. in their study of 78 patients with Grade 4 hemorrhoids showed a statistical difference in pain scores after first defecation and one week after surgery [In our study, the mean pain scores at 12, 24, and 48 hours were significantly lower in the group that underwent LIS in addition to haemorrhoidectomy. This is contrary to a study by Khubchandani who reported no statistical difference in postoperative pain, but this was attributed to performing LIS distal to the dentate line, terminating at the inter-sphincteric groove [The time taken for the first request of analgesia was similar in both groups and did not show a statistical difference - similar to the study by Khubchandani . GaliziaThe incidence of postoperative bleeding in our study was significantly lower in patients with LIS, whereas, among patients without LIS, 14 complained of moderate bleeding. The addition of LIS had no increased incidence of postoperative bleeding. This could be attributed to reduced straining during defecation due to relaxed anal tone and reduced spasm. Postoperative bleeding may cause anemia very rapidly in some patients. None of our patients experienced any adverse effects related to bleeding. Postoperative bleeding may be due to lack of thrombus or its expulsion or dissociation, and reabsorption of the transfixed stitch. Depending on the study considered, postoperative bleeding frequency varied between 0.6% and 10% .Urinary retention incidence in the postoperative period requiring catheterization in our study was 17% in patients with haemorrhoidectomy and 6% in patients with LIS and haemorrhoidectomy. Toyonaga et al.  in theirPostoperatively, patients having LIS may have a significantly increased risk of incontinence as suggested by some authors. Studies have also shown that sphincterotomy is accompanied by a low incidence of transient incontinence ,14. In oWe followed up our patients at six months and 24 months for anal fissure, anal stenosis, and bowel and gas incontinence. Patients developing anal stenosis usually have complaints of either anal pain, constipation, or bleeding ,16. AnalHaemorrhoidal recurrence occurs in around 2-8% of patients post-surgery . EarlierFrom our study, we conclude that postoperative pain, bleeding, and urinary retention were significantly lower after LIS, and gas incontinence was transient. The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after LIS. However, bowel and gas incontinence and recurrence were not altered. Therefore, we conclude that the addition of LIS to hemorrhoidectomy improves patient outcomes in terms of postoperative pain and anorectal function.


There is a paucity of data comparing effectiveness of various techniques for pain management of traumatic rib fractures. This study compared the quality of analgesia provided by serratus anterior plane (SAP) catheters against thoracic epidural (TEA) or paravertebral catheters (PA) in patients with multiple traumatic rib fractures (MRFs).354 patients who received either SAP, TEA or PA at two tertiary referral major trauma centers in the UK were included (2016–2018). Primary outcome were change in inspiratory volumes and pain scores. Secondary outcomes included in-hospital mortality, along with the length of stay in hospital and critical care. Data were analyzed using linear, log-binomial and negative binomial regression models.Across all blocks, there was a mean (SD) increase in inspiratory volume postblock of 789.4 mL (479.7). Ninety-eight per cent of all participants reported moderate/severe pain prior to regional analgesia, which was reduced to 34% postblock. There was no significant difference in the change in inspiratory volume or pain scores between the TEA, PA or SAP groups. Overall crude mortality was 13.2% (95% CI 7.8% to 18.7%). In an adjusted analysis and compared with TEA, in-hospital mortality was similar between groups (relative risk (RR) 0.4, 95% CI 0.1 to 1.0) and  for SAP and PA, respectively.SAP, TEA and PA all appear to offer the ability to reduce pain scores and improve respiratory function. Patients with thoracic trauma are at significant risk of morbidity and mortality from their initial thoracic injury or as a consequence of secondary insults such as atelectasis, pneumonia and acute respiratory distress syndrome. Pneumonia, as a complication of multiple rib fractures (MRFs), is diagnosed in 11%–31% of patients and associated with increased mortality.Regional analgesic techniques such as thoracic epidural (TEA) and paravertebral catheters (PA) have long been used as the ‘gold standard’ method in the multimodal approach of pain management. Their use, however, is limited due to concomitant injuries , contraindications (such as trauma-related coagulopathy and anticoagulant medications), multimorbidity  and inability to position the patient during the acute phase. Current literature reports TEA use between 9.9% and 18.4% in this group, with opioid analgesia, dominant.Thoracic wall fascial plane blocks with their ease of insertion, absence of beta-blockade effect with hemodynamic stability and safety are a welcome addition to the analgesic armamentarium in patients with MRFs.Pain scores can be static (when the patient is at rest) or dynamic (on movement and coughing). Dynamic pain scores are more pertinent in patients with MRFs as this would determine their ability to breathe deeply, cough and mobilize when they are most vulnerable to develop respiratory complicationsThe primary aim of this study was to compare the quality of analgesia, assessed by dynamic pain scores and inspiratory volumes, between SAP, TEA and PA catheters in a group of patients with traumatic MRFs. The secondary aim was to investigate if there was a difference in patient outcome between the three groups by analyzing the length of stay (LOS) and mortality data. Although systematic reviews have analyzed studies comparing TEA, PA, intercostal nerve blocks and opiate based treatments, to our knowledge, this is the first study to compare the effectiveness of SAP to PA or TEA.We included all consecutive adults with MRFs who received SAP, TEA or PA catheters and were admitted to hospital between 2016 and 2018 in two tertiary referral major trauma centers in the UK. Patients who had more than one type of regional anesthesia or who died within 24 hours of admission to hospital were excluded. Outcome data were collected from existing pain databases and patient records. This was merged with data from a high-quality national database provided by the Trauma Audit Research Network.The primary outcome measure was block effectiveness defined by a change in inspiratory volumes (mL) and dynamic pain scores, recorded before and after block insertion (within 90 min). Inspiratory volumes were measured with an incentive spirometer (mL). Pain scores were measured by a 4-point Likert Verbal Rating Scale (VRS) using standardized categories.Secondary outcome measures included the overall LOS in hospital, LOS in critical care and in-hospital mortality.Covariates included demographic data on age, sex, comorbid state as assessed by Charlson Comorbidity Index (CCI), injury severity score (ISS), abbreviated injury score (AIS) for each body system and outcome . Data on mortality are provided from in-hospital patient deaths before discharge. Rib fracture score (RFS) was captured from the electronic patient records; if not available, the investigators calculated it from the trauma CT scan (RFS=(number of breaks × side factor)+age factor).2 tests for categorical variables. Post hoc analyses were conducted for any significant omnibus results using the Tukey Honest Significant Differences for ANOVA and standardized residuals for χ2.Data were analyzed in R studio. Alpha was set to 0.05. All tests were two sided; thus, the null hypothesis reflected a belief that associations could be in either direction. Given that this is an exploratory analysis, we did not adjust for multiple comparisons. Differences in participant characteristics were assessed with analysis of variance (ANOVA) and χMissing data were handled using a pairwise deletion approach. Missing data were as follows for the sample overall who had either a PA, TEA or SAP catheter (n=354): age: n=3, ISS: n=8, RFS: n=31, CCI score: n=2, sex: n=3, isolated or polytrauma: n=3, mechanism: n=20, mechanism type: n=20, most severely injured body region: n=20, AIS score for the head, face, thorax, abdomen, spine, pelvis, limbs and other: n=20, preinspiratory and postinspiratory volume: n=231 and pre and post pain scores: n=155. Missing pain scores and inspiratory volumes were a result of patient inability to perform the tests due to intubation (n=50), confusion/reduced conscious level (n=8) and patient refusal (n=2). The remaining missing data had no reason provided. Generalized linear models specifying the binomial family and log link function  were used to assess difference in the number of participants moving from reporting severe/moderate pain preblock to mild/no pain postblock and in-hospital mortality. Generalized linear models specifying the Gaussian family and identify link function (similar to linear regression) were used to assess differences in change in inspiratory volume from the preblock to postblock measurement. Finally, generalized linear models specifying the negative binomial family with log link function  were used to assess differences in LOS in hospital/critical care among the three groups. Negative binomial models were used instead of Poisson regression due to the presence of overdispersion. Poisson and negative binomial models are recommended when predicting LOS as data are often skewed.Unadjusted and adjusted models are reported for each outcome. We adjusted for confounders that were chosen a priori, based on their expected associations with MRFs. For pain and inspiratory volumes, the following covariates were adjusted for: age, gender, ISS and RFS score. For in-hospital mortality and LOS, the following covariates were adjusted for: age, gender, ISS, RFS score, CCI, most severely injured body region , surgical rib fixation and isolated chest injury versus polytrauma.2 tests and ANOVAs.Data were collected on 354 patients who had either SAP (n=117), PA (n=68) or TEA (n=169). The PA group had a significantly lower proportion of patients with multiple injuries (polytrauma), endotracheal intubation and significant head injuries. The PA group also had significantly lower rib fracture (RFS) scores representing less severe chest trauma. The patient characteristics in the SAP and TEA groups were more comparable. However, the SAP group did have significantly more patients with severe head injuries compared with TEA and PA. The adjusted models selected aimed to account for these differences.All groups saw a clinically significant mean increase in inspiratory volume over time of 789.4 mL (SD 479.7 mL). The mean increase for each block type individually was: SAP 825.6 mL (SD 519.8 mL), PA 790.2 mL (SD 515.4 mL) and TEA 755.8 mL (SD 410.6 mL). There was no statistically significant difference in the magnitude of this change between the TEA and the PA or SAP groups see .The overall mortality rate was 13.2%% (95% CI 7.8% to 18.7%), 4.59% (n=5) of participants died in the SAP group, 4.55% (n=3) in the PA group and 7.56% (n=12) in the TEA group. In the adjusted model, there were no differences in mortality across block types .The overall LOS in critical care mean (SD) was 7.8 days (7.5) and in-hospital LOS was mean (SD) 18.2 days (17.4). The mean (SD) LOS in critical care was highest in the TEA group (9.6 days (9.3)), followed by SAP (9.4 days (10.0)) and lowest in the PA group (4.3 days (3.2)). The mean (SD) hospital LOS was highest in the SAP group (22.1 days (16.9)), followed by TEA (18.3 days (15.6)) and lowest in the PA (14.3 days (19.7)). In an adjusted model, no significant differences were found between groups with respect to hospital LOS . The PA The complete results of the adjusted and unadjusted models with associated p values are available in the supplementary material for inspiratory volumes and pain scores , mortali10.1136/rapm-2019-101119.supp1Supplementary dataOur study suggests that all three techniques of regional anesthesia contributed to reductions in pain and improvements in respiratory function and that postinsertion SAP is likely to be comparable with TEA or PA when used for the analgesia of MRFs. This is the first pragmatic study that has assessed analgesic adequacy in those receiving SAP, TEA or PA and so adds to the growing body of literature that has detailed a significant improvement in pain scores and inspiratory volumes following SAP analgesia.Previous systematic reviews comparing traditional analgesic modalities have not reported significant differences in mortality or LOS.From a population health standpoint, our SAP block findings are encouraging given the current underutilization of traditional techniques  in the setting of trauma. For example, it has been reported that fewer than 3% of patients in England and Wales in 2017 with rib fractures received TEA or PA.Our study has significant limitations. The heterogeneous nature of this cohort means that recommending a gold standard of analgesia is not possible.Our study did not make comparison with a non-block group. Therefore, we are unable to comment on whether a block relative to pharmacological methods such as opioids adds value or improves outcomes. Despite these limitations, our study has several strengths including data collection across multiple sites and the paired nature of the data with respect to analgesic assessment and changes in respiratory mechanics.In two large tertiary care hospitals in the UK, regional anesthesia appears to result in improvements in analgesia and respiratory mechanics in patients suffering from traumatic rib fractures. Given inherent limitations of TEA and PA blocks, SAP blocks may represent an attractive analgesic option for these patients.


Background and Objectives: To compare the long-term pain characteristics and its chronic management following minimally invasive spinal (MIS) decompression and open laminectomy with fusion for lumbar stenosis. Materials and Methods: The study cohort included patients with a minimum 5-year postoperative follow-up after undergoing either MIS decompression or laminectomy with fusion for spinal claudication. The primary outcome of interest was chronic back and leg pain intensity. Secondary outcome measures included pain frequency during the day, chronic use of non-opioid analgesics, narcotic medications, medical cannabinoids, and continuous interventional pain treatments. Results: A total of 95 patients with lumbar spinal stenosis underwent one- or two-level surgery for lumbar spinal stenosis between April 2009 and July 2013. Of these, 50 patients underwent MIS decompression and 45 patients underwent open laminectomy with instrumented fusion. In the fusion group, a higher percentage of patients experienced moderate-to-severe back pain with 48% compared to 21.8% of patients in the MIS decompression group (p < 0.01). In contrast, we found no significant difference in the reported leg pain in both groups. In the fusion group, 20% of the patients described their back and leg pain as persistent throughout the day compared to only 2.2% in the MIS decompression group (p < 0.05). A trend toward higher chronic dependence on analgesic medication and repetitive pain clinic treatments was found in the fusion group. Conclusions: MIS decompression for the treatment of degenerative spinal stenosis resulted in decreased long-term back pain and similar leg pain outcomes compared to open laminectomy and instrumented fusion surgery. The proportion of the elderly population in developed countries has been rising in recent years and is expected to continue to increase in the future. As a result, age-related degenerative diseases have become a common cause for those seeking medical treatment . Among tIn recent years, minimally invasive spinal (MIS) decompression has gained popularity as an alternative surgical procedure for the treatment of lumbar spinal stenosis . This apAlthough previous studies found that long-term functional outcomes of MIS decompression are similar to open laminectomy , it remaThe aim of the present study was to compare the long-term pain intensity, localization, frequency, and management of patients following MIS decompression and open laminectomy with fusion for the treatment of lumbar stenosis.This study was approved by our local Institutional Review Board and all patients provided informed consent before conducting the follow-up by phone interview. We retrospectively collected medical records on patients that underwent one- or two-level lumbar spine surgery between April 2009 and July 2013. All the patients that were referred to our unit completed a trial of various conservative treatments for at least six months. Treatments included oral analgesics, spinal injection, and radiofrequency combined with physiotherapy.At our institute, the Spine Service works in close collaboration with both the Pain Management and the Physical Medicine and Rehabilitation Departments. A multi-disciplinary team routinely evaluates patients prior to referral for surgery.Inclusion criteria included low back pain and radicular pain; neurogenic claudication, as defined by back and leg pain limiting ambulation and/or standing tolerance; and radiological evidence of degenerative lumbar stenosis with or without stable degenerative spondylolisthesis. Exclusion criteria included previous spine surgeries; three or more operated levels; the presence of a fracture or oncological pathology in the spine; and the presence of unstable spondylolisthesis, as shown in flexion–extension lumbar X-rays. The MIS group consisted of patients who underwent minimally invasive bilateral laminectomy via a unilateral approach, and the fusion group consisted of patients that underwent conservative open laminectomy with instrumentation and fusion. Patients’ pre-operative symptoms and spinal pathology, as evaluated using pre-operative MRI studies, were similar in both groups and the surgical procedure was elected solely on the basis of the treating surgeon’s preference and expertise. Patients were referred in an arbitrary manner to either a surgeon who is experienced in MIS or to a surgeon who is accustomed to performing laminectomies with an instrumented fusion to all degenerative cases who presented with significant degenerative changes in the discs and facet joints, even without radiological evidence of segmental instability. The rate of additional spinal surgeries following the initial surgery was also assessed between the groups.Out of 401 eligible patients from our medical records, 194 met the inclusion criteria. Phone interviews were done at least 5 years following surgery. Of these, 95 patients (50 patients in the MIS group and 45 in the fusion group) were available for follow-up and were included in the analysis. The remaining 99 patients were unavailable or refused to collaborate with the researchers when approached. The follow-up questionnaire assessed their chronic back and leg pain intensity and management. Patients were asked to assess their average pain intensity over the last year. For simplicity, we opted to use the Verbal Descriptor Scale (VDS) pain assessment over the standard ten-grade Numerical Rating Scale (NRS). The VDS includes 4 response options. Pain intensity was graded as follows: grade 1—no pain (NRS 0), grade 2—mild pain (NRS 1–3), grade 3—moderate pain (NRS 4–6), and grade 4—severe pain (NRS 7–10) .Pain frequency was assessed and categorized as follows: 1—experienced pain less than once a week, 2—experienced pain at least once a week, 3—experienced pain every day for less than one hour, 4—experienced pain for more than an hour a day, and 5—experienced constant pain throughout the day ,17. LastThe telephone interviews were conducted by two of the authors (R.A. and G.L.).All procedures were performed in a single medical center by senior spinal surgeons who were well experienced in MIS surgeries. MIS decompression procedures were done routinely under general anesthesia using an 18 or 20 mm tubular retractor system  and a surgical microscope. Surgery was performed using a unilateral approach, with either an ipsilateral or bilateral canal decompression while preserving the spinal midline structures, including the spinous process, supraspinous, and intra-spinous ligaments.p-value less than 0.05 was considered statistically significant.The data were analyzed using the IBM Corporation and other (8) 1989, 2019, Statistical Package for Social Sciences  version 24.0. The chi-squared and Fisher’s exact tests were used to evaluate the categorical variables. The non-parametric Mann–Whitney test was used to compare the continuous variables between the groups. A p > 0.01). The male/female ratio was similar in both groups (p = 0.2). The median follow-up period was 6.2 ± 1.6 years. No statistically significant differences were found in the number of operated levels, specific level of surgery and prevalence of degenerative spondylolisthesis, the clinical or radiological characteristics of patients, or the rate of lumbar spine reoperation in both groups (The mean age was 69.9 ± 11.7 years in the MIS group and 63 ± 13 years in the fusion group (h groups .p < 0.01)  .p < 0.01)  .p = 0.2)  .p < 0.05) (p < 0.05)  . Further < 0.05) .p = 0.6). In the fusion group, 22.2% of patients reported chronic use of some narcotic medications and 38.8% reported chronic use of non-opioid analgesics. In comparison, only 17.3% of patients in the MIS group reported chronic use of narcotic medications (p = 0.5) and 21.2% reported chronic use of non-opioid analgesics (p = 0.07). Moreover, 24.4% of patients in the fusion group reported that they continued treatment in pain clinics compared to 17.3% in the MIS group (p = 0.4). Thirteen percent of the patients in both groups reported using cannabis-based medication for their pain (p = 1)  ( (p = 1) .Spinal stenosis, with its insidious onset and chronicity, is a common cause of disability among the elderly population . ConservThis study compared two groups of patients that failed conservative treatment and underwent either MIS lamino-foraminotomy or open laminectomy and fusion for the treatment of degenerative lumbar stenosis. Although the underlying pathology and presenting symptoms of patients in both groups were similar, the surgical approaches that were used for their treatments were based on profoundly different strategies. In the fusion group, the surgeon opted to perform a wide laminectomy and bilateral facetectomy, necessitating the addition of instrumentation and fusion to address the risk of iatrogenic instability. On the other hand, in the MIS decompression group, the surgical procedure was performed with attention toward minimizing the damage to the paraspinal soft tissue and bony structures in an attempt not to change the native biomechanical characteristics of the spinal column, even when pathologies, such as degenerative spondylolisthesis and scoliosis, were noted.Previous studies found that following lumbar laminectomy, improvement in neurogenic claudication and radicular pain tended to decrease with time. This phenomenon was attributed to either same level re-stenosis or adjacent level stenosis ,20,21. PThe addition of an instrumented fusion should have a similar potential in improving patients’ long-term back pain. The immobilization of the arthritic facet joints and degenerative discs that often accompany spinal stenosis should reduce mechanical back pain. Earlier studies that followed up patients undergoing open laminectomy found that some of the patients experienced worsening of their axial back pain, which was attributed to iatrogenic spinal instability following the bilateral violation of the facet joints ,7. HowevOur results indicated that, in comparison with open decompression with fusion, MIS decompression may have superior long-term outcomes in terms of back pain intensity and frequency. In the fusion group, a significantly greater proportion of patients reported experiencing long-term intermediate-to-severe back pain compared with patients in the MIS decompression group. This finding was consistent with the higher percentage of patients in the MIS decompression group who reported having no back pain and a low frequency of pain. Although previous studies failed to show any differences in post-operative back pain when comparing open surgery to MIS decompression ,20,24,25The use of narcotic medication following surgical interventions, including spine surgery, may predispose patients to chronic opioid use and abuse. Several studies focused on identifying risk factors that predispose patients to this opioid dependency. Some studies found that performing instrumented spinal fusion was one of the leading risk factors that predicted prolonged opioid prescriptions in opioid-naive patients ,27,28. MWe also found a similar trend when analyzing the chronic use of pain medication in both groups. A higher percentage of patients from the fusion group was dependent on the chronic use of narcotic and non-opioid pain medications, as well as a higher percentage of patients that continued injection treatments at the pain clinic. However, this trend did not reach statistical significance, possibly due to the size of our cohort. Interestingly, we did not see any difference in the chronic use of cannabis-based medications between the groups.There are a few limitations to our study. First, this is a retrospective analysis of only half of the patients that met the inclusion/exclusion criteria due to lack of follow-up. Furthermore, the average follow-up time and the mean age of the patients were significantly different between the groups. The patients in the MIS decompression group were significantly older than in the fusion group and the mean follow-up time was longer in the MIS decompression group. However, since the minimum follow-up time was 5 years from surgery, we can reasonably argue that the pain parameters obtained at the actual time of follow-up represented the chronic pain condition of the patients. In addition, we would expect that the older age of patients in the MIS decompression group would have a negative effect on their general physical condition and pain levels. As such, these differences between the groups actually supported our findings since the MIS decompression group was found to have better pain-related outcomes compared to the fusion group. It is still possible that a randomized controlled trial on a large-scale  cohort could yield different results. Lastly, we were unable to attain detailed and reliable pre-operative pain measurements of the patients and compare them to their current pain levels. However, the strength of our study relied on the analysis of multiple variables in order to evaluate not only the pain intensity but also its frequency and different treatments, thus allowing for a better understanding of the pain’s impact on the patients’ lives. Such variables are usually not available when using large-scale spine registries but may provide additional insight, both from therapeutic and cost-effectiveness perspectives, in order to improve the quality of spinal health care.In conclusion, our results indicated that when comparing open laminectomy with fusion and MIS decompression surgeries for the treatment of lumbar spinal stenosis, we found a higher intensity of back pain and a trend toward increased chronic use of analgesic medication and interventional pain treatments in the fusion group. Additionally, performing open laminectomy and instrumented fusion provided no advantage compared to minimally invasive decompression for the treatment of patients’ radicular pain with stable lumbar canal stenosis. Future prospective studies are necessary to validate the specific advantages of minimally invasive techniques for spine surgery.


In chronic pain, it seems that the effect of cognitive-behavioral therapy (CBT) is boosted when it is combined with hypnosis. The aim of this study was to assess the efficacy of self-hypnosis combined with self-care  compared to music/self-care, self-care and psychoeducation/CBT and to evaluate their long-term effects.An open label randomized clinical trial enrolled patients with chronic pain and was carried out at the University Hospital of Liège (Belgium). Patients were randomized into four groups: self-hypnosis/self-care, music/self-care, self-care, psychoeducation/CBT (7 monthly sessions of 2 hours). Two follow-up sessions were delivered at 6- and 12-month. Levels of pain, fatigue intensity, anxiety, depression, insomnia severity, disability, health locus of control, mental and physical quality of life and attitudes  towards pain were assessed before and after the treatments, and at follow-up.203 patients were randomized: 52 in self-hypnosis/self-care, 59 in music/self-care, 47 in self-care, and 45 in psychoeducation/CBT. No group effect was found. A significant time effect was showed. Directly after the treatment, all groups decreased in pain attitudes and physical quality of life. Perceived control increased. At 6-month, all patients kept their levels of physical quality of life and perceived control, and showed decrease in pain intensity, harm, emotion and medical cure. At 12-month, scores that had change previously remained ameliorated, a decrease in insomnia severity and an increase in internal locus of control were observed.The present findings are encouraging as they display long-term beneficial effects of complementary biopsychosocial-based treatments in chronic pain. It seems that patients continued to apply the learnt strategies as improvements were observed one year after the treatments had ended. Pain is defined as “an unpleasant sensory and emotional experience associate with, or resembling that associated with, actual or potential tissue damage” in which sensory perceptions, emotional and cognitive processes intricately interact with one another . Pain caComplementary treatments are increasingly used by patients and are becoming more accepted in Europe. A study showed that 24.6% of people in Belgium used complementary treatments  during the 12 months prior to the study. Furthermore, compared to other chronic conditions  chronic pain conditions relied more on complementary treatments such as mind-body therapies  . NeverthThe goal of the Interdisciplinary Algology Department of the University Hospital of Liège (Belgium) is to assess non-pharmacological/complementary approaches in the management of chronic pain. Four complementary approaches—psychoeducation/cognitive-behavioral therapy (CBT), self-care, self-hypnosis combined with self-care (self-hypnosis/self-care) and specially composed music combined with self-care (music/self-care)—are proposed. The aim of psychoeducation is to enhance adaptive coping by informing the patient about pain’s physiological mechanisms, as well as the various consequences that can result from chronic pain such as emotional distress and alterations in cognition and behavior ,15. PsycThese complementary approaches have shown encouraging results in the management of chronic pain ,17. MoreThe current study was a four-arm parallel-design randomized controlled trial. Due to the type of intervention, neither patients nor therapist could be blinded, rendering this trial an open-labelled one. No changes in the The procedure included (1) a screening phase in which a medical doctor specialized in pain management  elaborated a pain diagnosis; (2) a baseline pre-treatment examination of patients’ health characteristics conducted by a nurse with questionnaires (T1); (3) a multidisciplinary meeting where the clinical team proposed a multidisciplinary approach and randomized patients into the treatment groups (carried out with the randomization function of Microsoft Excel); (4) a patient meeting with a pain specialist who proposed the treatment allocation; (5) a treatment phase (7 months); (6) a post-treatment assessment of patients’ health characteristics using the same questionnaires as in the pre-treatment phase (T2); two follow-up sessions and completion of the same questionnaires at (7) 6 months and (8) 12 months after the end of treatments. Each approach consisted of 7-monthly sessions of 2 hours plus two follow-up sessions of 2 hours (6 and 12 months). Each group session was composed of 8 patients. The functioning of these treatments was previously published in ,20.st 2019. The authors confirm that all ongoing and related trials for this intervention are registered. The full trial protocol is available in The study was approved by the Ethics Committee of the Medical School of the University of Liège, Belgium (reference number: 2015/85) and retrospectively registered on ClinicalTrials.gov  on October 21The randomization was carried out with the randomization function of Microsoft Excel by co-author A.V. This function was used for each participant. The multidisciplinary team all contributed to the recruitment and enrollment of the patients.th 2015 to December 5th 2017, chronic pain patients who attended the Interdisciplinary Algology Department of the University Hospital of Liège (Belgium) were recruited. The study started on March 17th 2015 and ended on February 6th 2020. Out of the 607 patients who attended the department, seven (1.1%) patients were not interested in the study, 23 (3.8%) did not complete the T1 questionnaires, one (0.2%) had another health issue (preventing her from attending treatments) and one other (0.2%) could not attend the group sessions because of for organizational purposes. Three hundred seventy-two (61.3%) patients could not be randomized as they came to the department with the specific demand to learn self-hypnosis/self-care, and thus their data were not considered in the present study. Ultimately, a total of 203 (33.4%) patients were included in this study and randomized into four groups: psychoeducation/CBT (n = 45), self-care (n = 47), self-hypnosis/self-care (n = 52), and music/self-care (n = 59). Patients were eligible for inclusion if they were: at least 18 years old, fluent in French, and had a diagnosis of chronic pain (pain > 3 months). Exclusion criteria were: psychiatric disorders , drug addiction, and alcoholism.From March 17Psychoeducation/CBT was conducted by two psychologists specialized in pain management (N.M. and I.S.). This is a cognitive-behavioral-based approach that aims to improve the self-management capacities and coping processes of patients with regard to their chronic pain. This intervention involved supportive group discussions. These discussions aimed to empower the patients to become active participants in their own treatment, and to provide them with a comprehensible model of pain mechanisms, an understanding of the rationale for pharmacological, physical and psychological therapy, and an acceptable rationale for making lifestyle changes. During these discussions, the psychologists gave a presentation on the understanding of the problems underlying chronic pain, on the biopsychosocial approach, and on the benefits of patient empowerment. Sessions also included open discussions on several themes, such as the specificities of chronic pain, the psychological factors linked to it, personal issues, attitudes and beliefs, and several tips on coping with the features of chronic pain. The aim of psychoeducation/CBT is thus to enhance adaptive coping by informing the patient about physiological pain mechanisms as well as the interactions between emotional distress, altered cognition and behaviors.Self-care was conducted by three psychologists  and by an algologist (M-E.F.). The self-care approach is an intervention developed by one of the co-authors (M-E.F.) based on her clinical experience with chronic pain patients. Similarities with Acceptance and Commitment Therapy (ACT) can be found in self-care. Indeed, its goal is not to suppress pain but rather to get the patients to tailor responses to their symptoms according to their own goals [wn goals . FurtherSelf-hypnosis/self-care was conducted by the four previously mentioned therapists , all of whom are specialized in clinical hypnosis. The aim of this treatment was the same as that mentioned above. In addition to the tasks, at the end of each session, a 20-minute hetero-hypnosis exercise was conducted by the therapist with the group of patients. Each patient also received individual CDs containing the hypnosis exercise from the session, and they were invited to perform the exercise on a daily basis in order to attain self-hypnosis. The first session was an introduction in which the therapist explained hypnosis and carefully corrected myths and misunderstandings patients had towards hypnosis. The seventh session was also an informative session where the therapist summarized the content of the six previous sessions and, talked about chronic pain its neurophysiology and other mechanisms inherent to this condition. For all hypnosis exercises, the therapist first invited the patient to take a moment to find a comfortable position, before continuing with the induction: visual fixation and/or breathing attention focalization. Five different hypnosis exercises were given. The first exercise, named “Soothing White Clouds”, included suggestions about relaxation, positive body sensations and an invitation to observe a sunrise and a beautiful landscape while relaxing in a white cloud chair [ud chair . The secMusic/self-care was conducted by the four previously mentioned therapists . The aim and the procedure were the same as in the “self-hypnosis/self-care” group, except no hypnosis exercise was given. Instead, at the end of each session, patients were invited to listen to a specially composed musical melody for 20 minutes. Each piece of music was specially composed by a certified music therapist (A.C.) according to the hypnosis exercise. It followed the rhythm of the hypnotic voice and the music therapist chose sounds that were representative of the metaphors utilized in the hypnotic script. Five CDs were given to each patient and they were asked to listen to them on a daily basis. Two additional CDs were given during follow-up sessions. Each group consisted of 8 patients. Music as a control for hypnosis was previously used and shown to be effective [ffective ,24.Data collection at the four time points , followed the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommendations :Medical and sociodemographic information of patients such as sex, age, educational level , occupational status, diagnosis (more than one diagnosis per patient possible), and pain duration. We also recorded if patients were part of the agreement between the Interdisciplinary Algology Department and National Institute for Health and Disability Insurance of Belgium (NIHDI) (named “convention” in this study). This agreement allowed a predetermined number of chronic pain patients to receive a multidisciplinary pain diagnosis and an adapted treatment program while the cost of clinical workup and treatment were directly reimbursed to the Interdisciplinary Algology Department by the NIHDI. The delay between the first contact of the patient with the Interdisciplinary Algology Department and the start of treatment was also collected via the medical record of the patient.Numerical Rating Scales (NRS) were used in order to assess pain and fatigue intensity, as subjectively perceived by the patients, on a scale ranging from 0 (no pain/fatigue) to 10 (pain/fatigue as intense as you could imagine) [imagine) ,27.The Hospital Anxiety and Depression Scale (HADS) was used to examine the levels of anxiety and depression subjectively perceived by patients. HADS is a 14-items self-report screening and contains two 7-items subscales for anxiety and depression, with a total score for each ranging from 0 to 21. The higher the score, the higher the symptoms [symptoms . The Fresymptoms .The Insomnia Severity Index (ISI) was administered in order to measure insomnia-related difficulties. It comprises 7 items that examine the severity of sleep onset, sleep maintenance, satisfaction with current sleep, interference of sleep difficulties with daily functioning, and noticeability of impairment due to sleep alterations [erations . The Freerations  was admiThe Pain Disability Index (PDI) was used to assess the repercussions of the interference of pain in the patients’ ability to engage in various activities. This is a self-reported scale rating the extent of disability in a target activity on a range from 0 to 10. PDI contains seven categories of life activities: family/home, responsibility, recreation, social activity, occupation, sexual behavior, self-care and life support activity. The higher the score attained, the higher the perceived disability [sability . The Fresability , was admThe Multidimensional Health Locus of Control Scale (MHLC) was used to measure the type of locus patients had. The scale is divided into three sub-scales [b-scales . The Intb-scales .The Survey of Pain Attitude-35 (SOPA-35) was administered to understand the attitudes and beliefs chronic pain patients endorsed. This scale is composed of 7 subscales. Harm measures the belief that hurt means physical injury. Disability assesses the belief that one is disabled by pain. Medication examines the belief that the best treatment is medication. Solicitude assesses the belief that it is the other’s responsibility to assist one with his/her pain. Emotion measures the belief that emotions influence the pain experience. Medical cure assesses the belief that it is the doctor’s duty to relieve one’s pain. Control measures the amount of control one believes one has over the pain experience. There is a specific score to each subscale—the higher the score, the more the patient endorses the belief [e belief .The Short Form-36 (SF-36) assesses global quality of life. This is a 36-item scale that comprises 8 subscales, from which 2 summary scores emerge: mental (MCS) and physical (PCS). The higher the score, the better the mental/physical quality [ quality . The Fre quality .The Patient Global Impression of Change (PGIC) was used to assess the patient’s belief about the efficacy of the treatment. It is a single item scale assessed through a 7-point scale. The higher the score the worse the improvement [https://eprovide.mapi-trust.org/instruments/patient-global-impressions-scale-change-improvement-severity.rovement . ContentWe used French validation for all questionnaires except the SOPA-35 and the pain and fatigue NRS. No changes to trial outcomes were carried out after the trial started.The sample size calculation was based on a repeated measure, between factor ANOVA a difference in mean scores using power calculation. Alpha was set at 0.05, power at 90% and the standardized effect size at 0.3. According to this analysis, 26 patients were required in each group for a total of 104 patients. According to the literature  and our χ2 test for qualitative variables and one-way ANOVA or its non-parametric equivalent Kruskall-Wallis test for quantitative variables. Then, repeated-measure ANOVA group-by-time was applied to examine the presence of significant differences in the mean scores of the 18 dependent variables  across 4 time points and 4 treatment groups, . Self-hypnosis/self-care was the reference category. Normality and homogeneity of the variance of the residuals were assessed graphically to check assumptions of models. When necessary, the models were adjusted for detected potential confounding factors. In case of group differences, multiple pairwise comparisons were performed. In addition, multiple comparisons using Bonferroni as correction (p = 0.01) method were realized between T1 and T2, T1 and T3, and T1 and T4. Results were considered significant at the 5% critical level (two-tailed p < 0.05). An Intention-to-Treat (ITT) procedure was used in order to included subjects who dropped out of the study [First, descriptive statistics were conducted. Qualitative variables were expressed with count and percentage. The normality of quantitative variables was examined numerically by comparing mean and median, graphically investigated histogram and quantile-quantile plots. A Shapiro-Wilk normality test completed this investigation of normality. If normality was assumed for the distribution of the quantitative variable, means and standard deviations were reported. Reversely, medians and interquartile ranges were presented. In order to detect potential confounding factors, baseline characteristics were compared between the 4 groups using he study . To thathe study  version As depicted in The mean age of patients was 46.7 years (±8.8) and, 182 (89.6%) patients were women. As presented in No significant difference was observed for all questionnaire variables across the four groups at pre-treatment (T1) (p>.05). Summary of the 19 variables at each time point and in each group are presented in As depicted in Finally, multiple comparisons using Bonferroni as correction (p = 0.01) method were conducted in order to assess between which points in time patients displayed an improvement. These analyses revealed that over time there was a significant decrease in pain intensity between T1 and T3 but not between T1 and T2 or T4. A significant decrease of insomnia severity (ISI) occurred between T1 and T4 but not between T1 and T2 or T3. Similar results were observed for the disability subscale of the SOPA-35. Furthermore, significant decreases between T1 and all other time points were found for 3 subscales of the SOPA-35  while no significant differences were observed for the medication subscale of the SOPA-35. Significant increases were observed between T1 and all other time points for the perceived control  as well as for the PCS subscale of the SF-36. Concerning the IHLC subscale of the MHLC, only a significant increase was found between T1 and T4. Supplementary information is available in The aim of this randomized longitudinal study was to assess whether self-hypnosis/self-care was more effective than music/self-care, self-care alone and psychoeducation/CBT. We further investigated the eventual lasting treatment effect at 6- and 12-month follow-ups. Our results showed a global effect of time for pain intensity, insomnia severity, physical quality of life, internal locus of health control and 6 subscales of the SOPA-35 , while no group effect was observed. Significant interactions group by time were found for physical quality of life (PCS), the solicitude subscale of the SOPA-35 and the patient global impression of change (PGIC), highlighting different patterns of effect of treatments across time in the four groups. Moreover, the beneficial effects retrieved directly after the end of the treatments were maintained for both 6 and 12 months, highlighting the fact that the patients seem to benefit from treatments over one year after they had ended. Nevertheless, since adherence was low, this result has to be taken cautiously.The present findings do not allow us to confirm our first hypothesis, i.e., the advantage of self-hypnosis combined with self-care, compared to the three other approaches. Jensen et al.  showed tIn our study, the absence of a group effect could be explained by the fact that all treatment groups aimed at empowering the patients. Empowerment can be viewed as a multidimensional process through which people are able to gain control over their lives by acting on difficulties they consider essential . EmpowerPatient health empowerment can be considered as a patient-centered approach . AlthougLimitations can be addressed in this study. First, treatment adherence was relatively low as only 40  of the patients participated until the 12-month follow-up session. Thus, applying the ITT technique rendered our analyses robust but could not reveal a group effect because too many patients maintained the same score (sometimes the T1 score) over the 4 time points. Furthermore, in another study  we demonIn conclusion, the current study showed the beneficial effect of self-hypnosis and cognitive behavioral based approaches on the quality of life of patients with chronic pain. It seems that patients continued to apply the learned strategies as improvement was observed one year after the treatments had ended. Furthermore, poor adherence at the one-year follow-up (19.7%) highlights the difficulty of carrying out these longitudinal studies. Nevertheless, this study is encouraging as it displays the beneficial effects of complementary biopsychosocial-based treatments in chronic pain management. This is of foremost importance as the aim of the multidisciplinary approach to chronic pain management is to enable the patients to be empowered and actively participate in their well-being, even after the treatment delivery. Finally, as chronic pain represents a worldwide health problem and an economic burden, it is necessary to assess the efficiency of biopsychosocial oriented treatment that represents a low cost for the patients (a maximum of 9 sessions in our study).S1 Checklist(DOC)Click here for additional data file.S1 File(DOC)Click here for additional data file.S2 File(DOCX)Click here for additional data file.S3 File(DOCX)Click here for additional data file.S4 FileAdjusted p-value with Bonferroni method.(DOCX)Click here for additional data file.S5 File(XLSX)Click here for additional data file.


As the number of bariatric operations increases, there is a greater interest in knowledge, experience and skills in the operative and anesthetic management of obese people. Anesthetic recovery is an important point in the therapeutic approach and less adverse effects delaying discharge of these patients are necessary to be kept in mind by the surgical team.  To compare anesthetic-analgesic techniques in the opioid-sparing era through epidural administration of local anesthetic associated with low-dose morphine vs. clonidine and analyze the impact of analgesia on the effectiveness of postoperative recovery by comparing these two techniques. Randomized, double-blind clinical trial with 66 patients candidates for Roux-en-Y gastrojejunal bypass divided into two groups: morphine group and clonidine group. Multimodal analgesia included epidural anesthesia with 0.375% ropivacaine 20 ml at the eighth thoracic vertebra with the association of morphine (morphine group) at a dose of 15 mcg / kg or clonidine (clonidine group) at a dose of 1 mcg / kg.  The groups were homogeneous and statistical significance was found when analyzing the difference in pain between them in the first postoperative period. The pain was higher in the clonidine group, as in this period, analgesic rescue was also better in this group. In the other times, there was no significance in the differences regarding pain and rescue. The return of intestinal motility in the morphine group was earlier in the first postoperative period. Nausea, vomiting and hospital discharge did not show significant differences between groups.  Epidural anesthesia with low-dose morphine allowed less pain during the entire hospital stay, with a positive impact on patient recovery. Obesity is defined as a metabolic disease in which the accumulation of adipose tissue has a proportion of body mass higher than normal, consisting of the fastest growing disease in Brazil and establishing itself as a major health problem,With the growing obesity epidemic, and a consequent increase in the number of procedures for its treatment and control, there is a greater interest in acquiring knowledge, experience and skills for the surgical and anesthetic management of these patientsPostoperative pain still persists as a significant and omnipresent adversity. It, at the same time, is associated with a myriad of postoperative complications that lead to delayed recovery and consequently delayed hospital dischargeDa Silva and Ribeiro (2011)With the use of opioids for pain management in large abdominal procedures - as proposed for this study - side effects such as nausea and vomiting, paralytic ileus, abdominal distension, urinary retention and consequent delay in hospital discharge, are expected.,,In the opioid-sparing era, we seek to optimize this recovery by reducing side effects with adequate analgesia and early dischargeThe objective of this clinical trial was to analyze the impact of analgesia on the effectiveness of postoperative recovery by comparing anesthetic technique with the use of neuroaxial opioids in reduced dose vs. opioid-free neuroaxial technique.In this randomized, double-blind clinical trial, 66 candidate patients for Roux-en-Y gastric bypass (RYGB) were recruited. It was approved by the Research Ethics Committee of Faculdade Evangélica Mackenzie do Paraná - CEP/FEMPAR and according to the attributions defined in Resolution 466/12 CNS under opinion number 3,466,603.After applying the inclusion and exclusion criteria, patients were randomized and divided into two groups: morphine group (MG) and clonidine group (CG). The operations were performed in a single institution - Hospital do Rocio, Campo Largo, PR, Brazil.2 associated with hypertension and/or diabetes or a BMI >40 kg/m2. Those with a history of postoperative nausea and vomiting, renal or hepatic insufficiency or dysfunction, coagulation disorders, heart disease and dipyrone and/or non-hormonal anti-inflammatory drugs allergy were excluded.Those who agreed to participate in the study were included by signing the informed consent form, and were elected on an outpatient basis by the surgical team for the proposed operation because they had a BMI >35 kg/m® program, in which the number provided corresponded to the group in which each patient fit. The RYGB surgical technique consists of a small gastric pouch (30 ml) created from an upper gastric area anastomosed to the small intestine that was sectioned 120 cm distal to the duodenojejunal flexure, creating a biliopancreatic and alimentary loop. The distal biliopancreatic segment was connected to the food loop, approximately 120 cm from the gastrojejunal anastomosis.Patients were randomly assigned to both groups. Randomization was performed using the RandomAnesthesia was standardized for both groups, with anesthetic induction with propofol 1.5 mg/kg , fentanyl 3 mcg/kg  and cisatracurium 0.15 mg/kg . Mechanical ventilation was used protectively with a tidal volume between 6-8 ml/kg , using an oxygen concentration of 30-50% with compressed air. The volume replacement therapy used was conservative with 15 ml/kg of Ringer-Lactate. Conventional monitoring included: cardioscopy with five leads, non-invasive blood pressure, pulse oximetry, anesthetic depth monitor performed with bispectral index (BIS) aiming at a target of 40-60, to ensure adequate hypnotic effect in general anesthesia and monitoring of neuromuscular block performed through “Train of four”(TOF), maintaining the value of 0 (zero) during the operation with TOF extubation criterion >0.9. Anesthetic maintenance was performed with sevoflurane, varying the expired fraction between 1.5-2.5%, according to the BIS target.The proposed analgesia was multimodal including dipyrone 2 g, ketorolac 30 mg and epidural anesthesia at the eighth thoracic vertebra (T8) with 0.375% ropivacaine 20 ml associated with morphine (MG) at a dose of 15 mcg/kg , whereas clonidine (CG) was at a dose of 1 mcg/kg . General anesthesia associated with epidural block was performed with the analgesic medication proposed for each group and with proper identification in the patient file. The prevention of nausea and vomiting was carried out with ondansetrone 8 mg, dexamethasone 4 mg and lizapride 50 mg. The analgesic rescue was performed sequentially with tramadol 100 mg in 100 ml of 0.9% saline up to 8/8 h, and in case of non-resolution of the pain, intravenous doses of morphine (0.05 mg/kg) could administered up to 4/4 h for control.After discharge from the post-anesthetic recovery room, patients were prescribed and medicated with ketorolac 30 mg every 8 h, dipyrone 2 g every 6 h and rescues as mentioned above with tramadol and morphine for those with Numerical Verbal Scale (NVS) >4. Prophylaxis of nausea and vomiting was performed intravenously with ondansetron 8 mg every 8 h and, if necessary, rescues was made with alizapride 50 mg until 8/8 h.The NVS scale was used for pain assessments, explaining to the patient that it could vary from 0 to 10, with extremes 0 being no pain and 10 being the worst possible sensation of pain. As well as the presence of nausea or vomiting, and the need for analgesic rescues was also assessed. Through the questionnaire “Douleur neuropathique 4 questions” (DN4) the score was analyzed, being considered pain with neuropathic characteristic if added 4 or more points. The return of intestinal function was analyzed through the presence of flatus and the absence of abdominal distensions associated with nausea and vomiting.st, 2nd and 3rd postoperative (PO) day. After discharge of the recovery room, pain was also investigated regarding its neuropathic character through the DN4 questionnaire and return of intestinal motility.The evaluation of the patients was performed by a second anesthesiologist, who was unaware of the medication used in each patient, as well as, which group belonged in the periods of immediate postoperative recovery, in the postoperative recovery, and in the 1st and 3rd quartiles, minimum and maximum values and standard deviation were considered. To summarize the qualitative variables, frequencies and percentages were presented. For comparison of the two groups, in relation to quantitative variables, Student’s t-tests for independent samples and non-parametric Mann-Whitney samples were used. Regarding qualitative variables, comparisons were made using Fisher’s exact test. For comparison of the moments, within each group, in relation to pain assessment, Friedman’s nonparametric test was considered. Values of p <0.05 indicated statistical significance. The data were analyzed using the IBM SPSS Statistics v.20.0 computer program. Armonk, NY: IBM Corp.For the description of the quantitative variables, the statistics of mean, median, 1The sample of this clinical trial consisted of 66 patients, 34 from the CG and 32 from the MG. st PO, decreasing to an average of 1.4 points in the 3rd PO; in the operating room and in the recovery room it was 0 and close to 0, respectively  occurred in the 1ectively . In the ent days .st PO, 1.6 points in the recovery room and 2 in the PO decreased to an average of 0.3 points in the 3rd PO .In the analysis of the needs for analgesic rescues, it was noted that in the two rooms there was no significant difference in the use of tramadol, as occurred in the 2When assessing the presence of nausea and vomiting in both groups at the moments studied, no significance was found in the differences found .st PO) in 12.5% vs. 0% in the CG (p=0.05) without statistical significance, as well as the other analyzes between the other moments in the groups As an alternative to opioids, alpha-2 agonists are available, commonly used in clinical practice such as clonidine and dexmedetomedine. Graff and Groser (2018)st PO and 2nd PO; consequently, it required a higher frequency of analgesic rescues at these times, however significant only in the 1st PO. It should be noted that in our analgesic technique we do not use epidural catheters for continued infusions.However, when comparing the two groups studied in this study, it was noted that the clonidine associated with local anesthetic in epidural anesthesia, had satisfactory pain control only in the initial postoperative recovery, that is , in OR and RR, showing a significant statistical difference when compared to the lowest mean of pain with the group that received low dose morphine in the 1In the study by Manion and Brennann (2011)And so, it was confirmed, although with a moderate quality of evidence, the systematic review of Cochrane 2016Regarding the presence of nausea and vomiting, a decrease in the incidence in the Odd group was expected, as mentioned above; however, at all times there were no differences with statistical significance, and it was also noted that in periods when the CG most needed pain relief with tramadol - a weak opioid - there was also no significant increase in the presence of nausea and vomiting.nd PO; however, the group that received morphine, no matter how significant, started to show this return of motility earlier than those who received clonidine.In another systematic review of Cochrane 2016In the study by Rosen et al. (2018)Fonseca, Gatto and Tondatto (2016)Comparing the two techniques, it can be concluded that epidural anesthesia containing low-dose morphine, compared to that with clonidine, showed uniformity of low pain indexes throughout hospitalization, causing a positive impact in relation to the recovery of patients undergoing RYGB.


The walking speed (+8%) and stride frequency (+5%) were significantly increased after SET (p ≤ 0.026). The stride length was only significantly increased during the pain-free walking condition , whereas no significant differences were observed during the condition of painful walking. Similarly, following SET, the relative duration of the loading response increased (+12%), the relative duration of the foot-flat phase decreased (−3%), and the toe-off pitch angle significantly increased (+3%) during the pain-free walking condition alone (p ≤ 0.05). A significant positive correlation was found between changes in the stride length  and stride frequency  during pain-free walking condition and changes in the 6MWD. A significant negative correlation was found between changes in the foot-flat phase during pain-free walking condition and changes in the 6MWD . SET was found to modify the gait pattern of patients with symptomatic PAD, and many of these changes were found to occur during pain-free walking. The improvement in individuals’ functional 6 min walk test was related to changes in their gait pattern.This study aimed to investigate the effects of supervised exercise training (SET) on spatiotemporal gait and foot kinematics parameters in patients with symptomatic lower extremity peripheral artery disease (PAD) during a 6 min walk test. Symptomatic patients with chronic PAD (Fontaine stage II) following a 3 month SET program were included. Prior to and following SET, a 6 min walk test was performed to assess the 6 min walking distance (6MWD) of each patient. During this test, spatiotemporal gait and foot kinematics parameters were assessed during pain-free and painful walking conditions. Twenty-nine patients with PAD (65.4 ± 9.9 years.) were included. The 6MWD was significantly increased following SET (+10%;  Lower extremity peripheral artery disease (PAD) is a chronic atherosclerotic vascular morbidity that leads to the narrowing and/or occlusion of lower-limb arteries . PAD affBeyond the well-known manifestations of reduced walking capacities, physical function, altered muscular characteristics, and impaired balance ,6,7,8,9,Cardiovascular risk management, pharmacological treatment, and exercise therapy are the main pillars of the treatment of PAD . FollowiThe question of whether SET induces gait changes, and whether the latter are related to treadmill performance in symptomatic patients with PAD, remains controversial ,28,29,30Previous investigations showed that the durations of the inner-stance phases  were altered during an acute treadmill exercise performed at a constant speed in patients with symptomatic PAD ,32. ThesThe primary aim of this study was to determine the spatiotemporal gait and foot kinematics parameters during an acute bout of 6MWT (acute adaptations) and in response to 3 month SET (chronic adaptations) in patients with symptomatic PAD. It was hypothesized that (1) SET would improve the 6 min walking distance (chronic adaptations); (2) SET would increase walking speed, and as well stride frequency and length (chronic adaptations); and (3) during the transition from pain-free to painful walking, similar acute gait adaptations would be observed during the 6MWT before and after SET.Symptomatic patients with chronic lower extremity PAD were recruited from the Division of Angiology of the University Hospital of Lausanne, Switzerland. As described elsewhere, all the participants were enrolled in the Angiofit study and took part in the SET program ,33. For Each participant underwent (i) a pre-SET vascular medicine examination; (ii) a pre-SET 6MWT with gait assessment; (iii) a 3-month SET program; (iv) a post-SET 6MWT with gait assessment; and (v) a post-SET vascular medicine examination.The medical history of each individual was assessed, and physical and vascular evaluations were performed. The ankle–brachial index (ABI) and toe–brachial index (TBI) were measured in accordance with the guidelines . ABI and6min) and distance (PFWD6min) during the 6MWT was recorded during the test. These values correspond to the time or distance covered by the patients until the onset of pain. At the end of the test, the rate of perceived exertion on Borg’s scale  [In an indoor 50 m corridor, the patients were asked to walk as far as possible within 6 min to determine their 6MWD . The pateffort”)  and the The patients participated in the clinical multimodal SET program, as previously described ,33,36,37During the outdoor Nordic walking sessions, the patients were asked to walk until they experienced moderate-to-severe claudication leg pain. Subsequently, the patients were asked to rest until they experienced complete  resolution of the pain. To enable complete supervision over the training sessions, patients were asked to walk back and forth over a 100–200 m section of level ground. In addition, the training intensity of the exercise sessions was also monitored using Borg’s scale . During The strengthening of the lower limbs was performed indoors with circuit training composed of 5–6 stations. Each station consisted of (1) a different type of walking, such as toe/heel, high knees, side-to-side, or backward walking, or (2) lower-limb resistance exercises  using body weight, dumbbells, or elastic bands. During the first few weeks of training, the patients were asked to perform 5–15 repetitions of each exercise using their body weight, interspersed with 30 to 60 s of recovery. The exercise training intensity was mainly set at a low level. In the following weeks, the patients were encouraged to exercise at a moderate intensity . To that end, the patients were asked to increase the number of repetitions (20–30 repetitions using their body weight) or to exercise using dumbbells or elastic bands (10–20 repetitions).During the program, the patients received 6 h of therapeutic workshops on cardiovascular risk factors and a healthy lifestyle . Compliance with the SET program was defined by the percentage of attended sessions out of the total number of sessions .®  inertial sensor units  [® units integrate a microcontroller, a memory unit, a three-axial accelerometer (range ±3 g), a 3-axial gyroscope (range ±800° s−1), and a battery [® units have been validated in young [During the 6MWT, the patients wore two Physilogt: 36 g) ,39. Thest: 36 g) ,39. Phys battery ,39. The in young ,39. In ain young . Finallyin young  and in pin young .The spatiotemporal gait and foot kinematics parameters were recorded during the whole 6MWT. For the analyses, ten consecutive strides were selected 1 min after the beginning of the test  and before the end of the 6 min walk test during the painful walking condition (pain).During the 6MWT, walking speed, spatiotemporal gait, and foot kinematics parameters were assessed. Stride length was the only spatial parameter. The temporal parameters were stride duration and frequency  and the relative duration of the swing, stance, and double support phases (% of gait cycle duration). In addition, the relative duration of the inner-stance phases  were also reported ,39. The The symmetry between the legs was assessed by dividing the values of the most symptomatic leg by those of the less or non-symptomatic leg .p ≤ 0.05. SPSS 27 software  was used for the statistical analyses.The sample size was estimated using our previous data , showingTwenty-nine symptomatic patients with chronic PAD were included. All the patients completed the 3 month SET program. Their general characteristics are reported in p = 0.829) and TBI  were unchanged following SET.The values regarding the ABI . This suggests that similar acute and chronic adaptations were present in both legs of the participants. Therefore, for sake of clarity, only the results regarding the most symptomatic leg were presented.During the 6MWT, a significant duration effect was observed for all the spatiotemporal gait parameters . Multiplp ≤ 0.026, A significant time and time × duration interaction effect was found with regard to the walking speed . Multiplp = 0.013). Compared to the values recorded before SET, stride length was significantly increased following SET during the pain-free walking condition alone (p = 0.001), whereas no significant differences were observed during the painful walking condition (p = 0.569).A significant time and time × duration interaction effect was found regarding the stride length . Multiplp ≤ 0.001) with no significant time × duration interaction effect ; however, a significant time × duration interaction effect was observed (p = 0.008). Similarly, a significant decrease in the relative duration of the swing phase was observed during the painful condition compared to the pain-free walking condition following SET alone (p = 0.008).After SET, the relative duration of the stance and swing phase was unchanged (time effect: observed . Multiplp = 0.013). After SET, there was a significant increase in the relative duration of the loading response during the pain-free walking condition alone (p = 0.001), whereas no significant differences were observed during the painful walking condition (p = 0.523).A significant time and time × duration interaction effect was observed regarding the relative duration of the loading response . Multiplp = 0.139); however, a significant time × duration interaction effect was observed (p = 0.002), whereas no significant differences were observed during the painful walking condition (p = 0.420).The relative duration of the foot-flat phase was unchanged after SET ; however, a significant time × duration interaction effect was observed (p = 0.05), whereas no significant differences were observed during the painful walking condition (p = 0.938). No significant time and time × duration interaction effect was observed regarding the heel-strike pitch angle, maximal heel clearance, second maximal toe clearance, or minimal toe clearance  SET improved the 6MWD in patients with symptomatic PAD; (2) following SET, walking speed, stride frequency and stride length were significantly greater during the 6MWT. However, stride length was significantly increased following SET during the pain-free walking condition alone, whereas no significant differences were observed during the painful walking condition. Similarly, changes in the relative duration of the inner-stance phases (loading response and foot-flat) and the toe-off pitch angle following SET were observed during the pain-free walking condition alone; (3) during the transition from the pain-free to the painful walking condition, the spatiotemporal gait and foot kinematics parameters were shown to undergo a similar evolution before and after SET during the 6MWT. Finally, our results showed that changes in stride length and frequency and in the relative duration of the foot-flat phase during the pain-free walking condition were related to changes in functional walking performance during the 6MWT following SET.The results of the present investigation confirm previous findings, which showed that SET improves 6MWD in symptomatic patients with PAD ,23. We oDuring the transition from the pain-free to painful walking conditions, similar acute adaptations were observed for the spatiotemporal gait and foot kinematics parameters during the 6MWT before and after SET. These results extend previous findings observed during constant-speed treadmill exercises in patients with symptomatic PAD ,29 and hIn current research, there are a limited number of studies regarding gait pattern changes following exercise interventions in patients with symptomatic PAD, and the findings are inconsistent. Indeed, some studies ,29,30,49The use of non-invasive inertial sensors with the aim to investigate gait pattern during physical assessment has potential applications with regard to the optimization of the prescription of training in patients with PAD. Indeed, these inertial sensors may easily assess gait pattern evolutions during functional acute exercise performed before and following an exercise training program. This technology allows one to evaluate the gait changes in the transition from the pain-free to painful walking condition, and therefore produces a valid description of daily-life walking pattern in these individuals. In addition, by evaluating the potential correlation between gait pattern and functional performance changes following rehabilitation, specific training approaches could be conceived to optimize patients’ benefits. Interestingly, our results showed that the changes in stride length and frequency during the pain-free walking condition were positively correlated to changes in 6MWD. In addition, the changes in the relative duration of the foot-flat phase during the pain-free walking condition were negatively correlated with changes in 6MWD. These findings suggest a link between changes in gait pattern during the pain-free walking condition and improved functional walking performance in patients with symptomatic PAD. These results feature important clinical implications and indicate the need for further investigations regarding the effects of specific gait training modalities on gait pattern and its relation to functional walking performance in these individuals. A previous meta-analysis showed that walking training with cueing of cadence improves spatiotemporal gait parameters more than walking training alone in older patients with cardiovascular disease . WalkingThis study featured some limitations. First, the present investigation lacked a control group that did not participate in the 3 month SET. Even though previous findings showed no difference in gait pattern over time in patients with PAD who did not participate in a vascular rehabilitation program , future In conclusion, these results show that multimodal SET modifies gait pattern during the 6 min walk test in patients with symptomatic PAD. However, many of these changes  only occurred during the pain-free walking condition, highlighting the role of claudication pain in gait pattern in this population. In addition, changes in stride length and frequency and in the relative duration of the foot-flat phase during the pain-free walking condition were correlated with changes in 6 min walking distance. These findings suggest that new rehabilitation strategies, including specific gait training modalities, should be further investigated in this population.