Residual back pain (RBP) after percutaneous vertebral augmentation (PVA) still exists considerable, and it even affects daily life due to moderate or severe back pain. A variety of risk factors have been previously identified for developing residual back pain. However, there are conflicting reports regarding the association between sarcopenia and residual back pain. As such, the aim of this study was to investigate whether paraspinal muscle fatty degeneration is a predictor of residual back pain.We retrospectively reviewed the medical records of patients with single-segment OVCF who underwent PVA from January 2016 to January 2022. Patients were divided into RBP group (86 patients) and control group (790 patients) according to whether the visual analog scale (VAS) score ≥ 4. The clinical and radiological data were analyzed. Paraspinal musculature fatty degeneration was measured using the Goutallier classification system (GCS) at the L4 − 5 intervertebral disc level. Univariate and multivariate logistic regression analyses were performed to identify risk factors.P < 0.001), as regards paraspinal muscle fatty degeneration, including Goutallier grading , fCSA , fCSA/CSA (%) , and facet joint violation  were identified as independent risk factors for RBP.The results of multivariate logistical regression analysis revealed that posterior fascia injury (odds ratio (OR) = 5.23; 95% confidence interval (CI) 3.12–5.50; Posterior fascia injury, paraspinal muscle fatty degeneration, and facet joint violation were identified as independent risk factors for RBP, with paraspinal muscle fatty degeneration playing an important role. Osteoporotic vertebral compression fracture (OVCF) is becoming a common source of back pain and progressive spinal deformity, reducing quality of life and becoming an increasingly serious health problem worldwide . TreatmeHowever, several scholars were still skeptical about the analgesic effect of PVA , 6. ResiThis retrospective study analyzed 876 patients with OVCF who underwent PVA in the authors’ institution between from January 2016 and January 2022. This study protocol was approved by the Medical Ethics Committee of our Hospital, and all patients obtained preoperative informed consent.Inclusion criteria were as follows: (1) patients diagnosed with OVCF; (2) treated with PVA; (3) follow-up period of more than 12 months.Exclusion criteria were as follows: (1) defined cement leakage into spinal canal, (2) patients with neurological deficits, (3) new postoperative vertebral fracture or postoperative infection, (4) combined with malignant tumors of the spine, (5) combined with severe cardiac and pulmonary dysfunction, unable to tolerate surgery.The following clinical and radiographic data were recorded: demographic data ), comorbidities  and others), preoperative VAS, preoperative imaging data , injured vertebral segment, vertebral height loss, local kyphosis angle, intravertebral vacuum cleft, posterior fascia injury and paraspinal muscle fatty degeneration), surgical data , postoperative radiological parameters  and postoperative bracing treatment.2) was calculated as weight (kg) divided by the height squared (m2). In terms of injured vertebral segment, the thoracic junction, thoracolumbar junction, and lumbar junction were defined as T5–T9, T10–L2, and L3–L5, respectively. Vertebral height loss was calculated as the percentage of anterior vertebral body height relative to the average anterior vertebral body height of the upper and lower adjacent levels [BMI  of the bilateral paraspinal muscles at the L4 − 5 intervertebral disc level . PatientThe cross-sectional area (CSA) of the paraspinal muscle was evaluated using the region of interest (ROI). The functional cross-sectional area (fCSA) of the paraspinal muscle was measured using the threshold method. The fCSA referred to the fatfree, lean paraspinal muscle. Images were processed using ImageJ software . Signal intensity was represented by the mean grayscale of the ROI quantified by the software, with higher scores indicating greater intensity. Wide oedema, haemorrhage, and inflammation were excluded in consideration of measurement bias. Finally, the results of the two observers were averaged. ROI-CSA and ROI-fCSA were recorded as the mean values of both muscle regions in each patient. The ratio of fCSA/CSA was analyzed, and it decreased as the muscles atrophied or more fat infiltrated them. Considering the wide differences among individuals, the ratio of CSA to disc CSA (D-CSA) was used to balance body size differences in the aforementioned parameters.Vertebral height restoration was calculated as the percentage of the anterior vertebral body restoration height relative to the average anterior vertebral body height of the upper and lower adjacent levels. A satisfactory cement distribution was defined when the spongiform dispersive bone cement in contact with the upper and lower endplates, and an unsatisfactory cement distribution was defined when the bilateral cement masses were isolated and rarely connected to each other . Facet jFor patients with residual low back pain, thoracic and lumbar MRI examinations were performed at the one year postoperative outpatient follow-up to detect a new fracture. The visual analog scale (VAS) was used to evaluate the RBP, with a score of 0 indicating no pain and 10 indicating the most severe pain. In this study, the patients were divided into RBP group (VAS score ≥ 4) and control group (VAS score < 4).All procedures were performed by senior physicians with PVA qualifications. The patient was in a prone position, and fluoroscopic positioning was performed by a C-arm X-ray machine. Local anaesthesia was performed on the articular capsule, the local muscle, and the fascia before diaplasis. The needle was inserted through unilateral or bilateral pedicle surface projection positioning of the surgical vertebrae. Then, the guide needle, dilation cannula, and work cannula were replaced sequentially under fluoroscopy. The C-arm X-ray machine fluoroscopy determined that the puncture needle exceeded the posterior edge of the vertebral body, and the needle tip did not cross the medial cortex. The needle core was pulled out after the satisfactory position was determined by lateral fluoroscopy. Surgical procedures for PVP patients: under the fluoroscopy of the C-arm X-ray machine, the pressure syringe was used to inject the high-viscosity or low-viscosity bone cement into the responsible vertebra. Surgical procedures for PKP patients: prior to injection of bone cement, a deflated balloon was placed into the vertebral body and inflated to restore the height of surgical vertebrae and the balloon was then deflated and withdrawn. In addition to using the balloon, the operation steps of PKP were similar to the previous method. Finally, the diffusion, distribution, displacement, and leakage of bone cement were observed under the fluoroscopy of the C-arm X-ray machine. After satisfactory, the injection device was removed, the wound was compressed to stop bleeding, and a sterile dressing was applied.Patients were prescribed calcium tablets (600–1200 mg/day), calcitriol (0.25–0.5 μg/day), and alendronate (70 mg/ week) after surgery. Regarding pain management, patients who acquired adequate pain relief were not prescribed any analgesic drug, and those who still suffered from inadequate pain relief or pain obviously affecting basic daily life were prescribed non-steroidal anti-inflammatory drugs (NSAIDs); non-opioid analgesic drug was added if the NSAIDs were not effective.t test while categorical data were compared using the Fisher’s exact test and chi-square test. Multivariable analysis was performed using multiple logistic regression. Parameters were included in multivariable analysis based on clinical significance and statistical significance in univariable analysis. P-value < 0.05 was considered statistically significant.All data were analyzed with SPSS version 26 . Quantitative data were presented as the mean ± standard deviation and compared with Student’s 2 . BMD with T-value ranging from − 2.5 to − 5.7 SD . The associated clinical and radiological characteristics are described in Table In the present study, a total of 86 patients out of 876 patients with OVCF had poor postoperative back pain relief, and these patients were classified as the RBP group (VAS score ≥ 4). Mean age was 76.2 ± 8.4 years; 567 were female and 309 were male. The mean BMI was 23.8 ± 3.1 kg/mP > 0.05). With respect to paraspinal muscle fatty degeneration, there were no statistically significant differences in CSA and CSA/D-CSA (P > 0.05), but when comparing the data in the Goutallier grading, fCSA and fCSA/CSA, the difference was significant (P < 0.001). The results also showed that the following factors were significantly different between the control and back pain groups: BMD (P < 0.001), intravertebral vacuum cleft (P = 0.005), posterior fascia injury (P < 0.001), cement distribution (P = 0.004), and facet joint violations (P < 0.001). Collectively, these data indicated that the above factors were potentially associated with postoperative back pain and were included in the multivariate analysis.Comparisons of patient-independent variables between the RBP and control groups are summarized in Table P < 0.001), as regards paraspinal muscle fatty degeneration, including Goutallier grading , fCSA , fCSA/CSA (%) , and facet joint violation  were identified as independent risk factors for RBP.Multivariate logistical regression analysis was performed to detect independent risk factors for RBP. As shown in Table P < 0.001), as regards paraspinal muscle fatty degeneration, including Goutallier grading , fCSA , fCSA/CSA (%) , and facet joint violation  has a more significant impact on RBP.Although PVA provides quick pain relief, improved physical function, and good restoration of vertebral height, some patients still experience considerable residual back pain. In addition, although sarcopenia is known to compromise quality of life and increase the risks of falls and disability in elderly patients, there has been few studies on how paraspinal muscle fatty degeneration contributes to poor clinical outcome after PVA. Therefore, we deeply investigated whether paraspinal muscle fatty degeneration is an independent risk factor of RBP following PVA. The result demonstrated that posterior fascia injury (odds ratio (OR) = 5.23; 95% confidence interval (CI) 3.12–5.50; In our study, posterior fascia injury was found to be an independent risk factor for RBP. Yan et al.  determinThe finding that paraspinal muscle fatty degeneration is a risk factor for RBP after PVA has rarely been mentioned in previous studies. This study investigated the effect of quantitative analysis and fatty degeneration of the paraspinal muscle on the residual back pain, in addition to the risk factors for poor efficacy described in previous studies. The paraspinal muscles play a critical role in the stability and functional movement of the spine . Habibi Moreover, multivariate analysis of this study showed that facet joint violation was another risk factor for postoperative pain. Lin et al.  found thThe limitations of the present study mainly include the following items: first, our study is a retrospective single-center study with a small number of cases, and the data contained do not record the location and severity of bone cement leakage. Therefore, a prospective, multicenter study with a larger sample size is needed to verify the conclusions of this study. Second, the patients were divided into two groups based on VAS scores at one year of follow-up and did not compare differences during follow-up. Nevertheless, several risk factors for residual back pain were confirmed, at least in part, especially highlighting the importance of paraspinal muscle fatty degeneration and they will be important for improving surgical efficiency.In conclusion, posterior fascia injury, paraspinal muscle fatty degeneration, and facet joint violation were identified as independent risk factors for RBP, with paraspinal muscle fatty degeneration playing an important role.


Background: We have developed a novel technique for managing rotator cuff calcific tendonitis, involving arthroscopic debridement of calcific tendonitis with localization assistance from a breast biopsy needle under ultrasound guidance. While we have demonstrated encouraging results at six-month follow-up, the medium-term outcomes and the long-term outcomes of this technique at 2 years or beyond are unknown. The aim of this paper was to determine if this technique was successful in resolving symptoms after two years and beyond. Study Design: Retrospective Cohort Study. Methods: Patients who underwent arthroscopic debridement of calcific tendonitis with localization assistance from a breast biopsy needle under ultrasound guidance by a senior surgeon were evaluated using patient-rated pain scores and functional status with the use of the Likert scales and via examiner-rated shoulder range-of-motion and strength at the pre-operative visit, at 1, 6, 12, and 24 weeks post-operatively, and long-term at a mean of 249 weeks after surgery. Results: At a mean follow-up period of 4.8 years , 31 patients (33 shoulders) experienced significant improvement in the severity of pain at rest, with overhead activities, and during sleep compared to their pre-operative presentation (p < 0.001). The patient experienced less frequent pain during activities and sleep, and a decreased frequency of extreme pain (p < 0.001). Passive range of abduction (p = 0.003), forward flexion (p < 0.001), and supraspinatus strength (p = 0.018) improved compared to the presurgical presentation. Out of 27 patients, 24 patients (89%) had complete resolution of calcific tendonitis, and 26 patients (96%) had an intact rotator cuff. Conclusion: Arthroscopic debridement of calcific tendonitis with localization assistance from a breast biopsy needle under ultrasound guidance was very effective. Patients had significant pain relief, improved range of motion, and a reduction in stiffness at a mean post-operative period of 4.8 years. Patients had a significant reduction in residual calcification, and rotator cuff integrity was largely preserved by long-term follow-up. What is known about this subject: Calcific tendonitis of the rotator cuff is one of the most painful and debilitating disorders of the shoulder. This condition is characterized by the deposition of calcium-phosphate crystals within the rotator cuff tendons. Arthroscopic debridement and excision of rotator cuff calcifications have proven to be efficacious treatments with regards to clinical and functional outcomes in the short and medium term. Identifying the calcific lesion intra-operatively, however, can prove to be challenging. Furthermore, inadequate excision of the calcific deposit has been shown to have poorer clinical outcomes. We designed a technique that utilizes the assistance of ultrasound to guide a localization-biopsy wire to the calcific lesion. This technique aids in precisely identifying the location of the lesion intra-operatively to optimize accuracy in removing the maximum amount of calcific deposit possible. A short-term follow-up study by us has demonstrated successful outcomes with regards to the return of function and relief of pain. However, there have been no studies evaluating the effectiveness of this particular technique beyond six months. What this study adds to current knowledge: At a mean of 4.8 years, arthroscopic debridement of calcific tendonitis, using our technique, was successful in relieving the severity and frequency of pain with overhead activities, pain at rest, and pain during sleep, as well as improving range of motion. Calcific tendonitis of the rotator cuff is one of the most painful and debilitating disorders of the shoulder. This disorder typically presents with pain aggravated by abduction , and tenThe etiology and pathophysiology of calcific tendonitis are undetermined. This condition is characterized by the deposition of calcium-phosphate crystals within the rotator cuff tendons, primarily involving the supraspinatus tendon (80%) . HackettFirst-line management of calcific tendonitis is often via non-steroidal anti-inflammatory drugs, corticosteroids, extracorporeal shockwave therapy, and ultrasound-guided percutaneous lavage ,12,13,14We designed a technique that utilizes the assistance of ultrasound to guide a localization-biopsy wire to the calcific lesion. This technique aids in precisely identifying the location of the lesion intra-operatively to optimize accuracy in removing the maximal amount of calcific deposit possible . A shortThis was a retrospective cohort study. Ethics approval was obtained from the South Eastern Sydney Local Health District Human Research and Ethics Committee (SESLHD). Patients were included in this study if they were diagnosed with calcific tendonitis of the rotator cuff, underwent a primary arthroscopic ultrasound-guided debridement of calcific tendonitis with the assistance of a localization wire (performed by the senior surgeon), and attended a minimum two-year follow-up period.Patients were excluded from this study if they had (1) prior surgery for calcification; (2) irreparable rotator cuff tear in the affected shoulder; or (3) severe (above grade 3) osteoarthritis in the affected shoulder. The criteria used by our facility for a diagnosis of calcific tendonitis were (1) a history or presentation with shoulder pain and (2) visualization of a calcific lesion on diagnostic ultrasound and/or X-ray imaging.®, Mountain View, CA, USA)) was used to locate the calcific lesion. After the calcific deposit was identified, the skin around the lateral portal was sterilized with standard betadine-alcohol surgical preparatory solution. Under ultrasound guidance, a breast-biopsy localization wire with its introducer needle  was entered through the skin and into the subacromial space, and was placed into the calcific deposit  was applied to the skin, securing the flexible wire onto the skin.http://vumedi.com (accessed on 4 April 2020) [Diagnostic glenohumeral joint arthroscopy was conducted through a posterior portal to assess intra-articular pathology, and then the arthroscope was moved to the subacromial space. Using a spinal needle, a standard lateral portal was established, and the localization wire was identified and followed, leading towards the location of the calcific deposit. The integrity of the rotator cuff was visually assessed, and then the localization wire was removed. The calcific lesion was then decompressed through the lateral portal via trephination with an 18-gauge spinal needle, with the calcific material usually extruded in a “snowy” pattern. A small (4 mm) diameter motorized shaver (Stryker) was used to further debride the lesion. After removal, the remaining rotator cuff tendon was assessed for defects. Small defects were not repaired, but significant defects, if present, were repaired. Further information regarding this procedure is available in the initial technique paper (a video demonstration of the above procedure is available at il 2020) .The wound was subsequently closed via 3–0 prolene sutures and dressings, and a sling for comfort was applied. Routine post-operative protocols consisted of range-of-motion exercises and gradually increased shoulder activity . If a roPatients completed a standardized modified L’Insalata shoulder questionnaire at each clinical visit . On the questionnaire, there were several categories of rating: the frequency of pain during activity, at sleep, and at extreme levels; the level of pain at rest, during overhead activities and when sleeping; level of shoulder stiffness; difficulty in reaching behind the back and overhead; overall shoulder rating; current level of activity at work and current level of sport, based on Likert scales [Patient answers were converted to the numbers in the brackets as seen for further statistical analysis. Patients responded to questions concerning the frequency of pain with never (0), sometimes (1), monthly (2), weekly (3), and all the time (4). The responses to questions the about level of pain were ranked from none (0), mild (1), moderate (2), severe (3) and very severe (4). The level of overall shoulder stiffness was categorized as not at all (0), a little (1), moderately (2), quite (3) or very (4). The categories for questions pertaining to difficulty with activities reaching behind their head and overhead were none (0), mild (1), moderate (2), severe (3) or very severe (4). Patients ranked their shoulder status as good (4), fair (3), poor (2), bad (1) or very bad (0). The level of activity at work and level of sport being played were separated into none (0), light (1), moderate (2) and strenuous (3); and none (0), hobby (1), club (2) and national (3), respectively.Shoulder range of motion and strength were also tested in this study by trained examiners. Shoulder passive range of motion was assessed in the following movements: forward flexion, abduction, external rotation, and internal rotation. Passive range of motion was performed by visual estimation with this technique shown previously to have fair to good reliability . The angShoulder strength was tested in internal rotation, external rotation, empty can position (supraspinatus), lift-off test, and adduction. Strength was measured utilizing handheld dynamometers, which were shown to be an objective method to measure shoulder strength, with high inter-rater and intra-rater reliability ,27,28. Mp ≤ 0.05.Statistical analysis was conducted using Microsoft Excel and SPSS Statistics . Multiple paired T-tests were utilized for parametric data, data involving range of motion and strength assessment. Wilcoxon signed-rank tests were utilized for non-parametric data, data involving pain assessment, and comparison of pre-operative scores versus post-operative scores of the same individuals within this longitudinal study. All results were reported as mean ± standard error of the mean. Statistical significance was set at The primary outcome was the impact of this procedure on patient-reported severity and frequency of pain  at minimum two years from surgery, compared to pre-operatively. Secondary outcomes were the examiner-determined shoulder range of motion and strength , stiffness, presence of calcium deposits, and whether there were any re-tears in the rotator cuff tendon that underwent calcific removal.During the study period, the senior surgeon performed 37 cases of ultrasound-guided breast biopsy wire-assisted arthroscopic debridement of calcific tendonitis in 35 patients. Four patients were not included in this medium-long-term follow-up study, as they were lost to follow-up. The study sample therefore consisted of 33 shoulders (of 31 patients). The population group was followed up at a mean of 4.8 years post-debridement with a range of 2 to 10 years. The mean age of the study group was 54 years, with a range of 38 to 76. The study group was comprised of 10 males and 21 females. There were 18 right shoulders and 15 left shoulders assessed in this study .Prior to surgery, patients in this cohort, on average, rated their pain with overhead activities as ‘moderate’ to ‘very severe’ and their pain at rest and overnight as ‘mild’ to ‘very severe’ .With regards to pre-operative pain frequency, patients reported their frequency of pain with overhead activities and pain during sleep between ‘daily’ and ‘always’, while the frequency of extreme pain was between ‘weekly’ and ‘always’ .The cohort ranked their overall shoulder status between ‘poor’ and ‘very bad’ . The cohp = 0.001). The frequency of extreme pain also decreased from ‘daily’ to between ‘none’ and ‘weekly’ (p = 0.005). The level of pain during sleep decreased from between ‘severe’ and ‘moderate’ to between ‘moderate’ and ‘mild’ (p = 0.004), while the frequency of pain during sleep decreased from ‘always’ to between ‘daily’ and ‘weekly’ (p = 0.005)  .p < 0.001), pain with overhead activity (p < 0.001) and pain during sleep (p < 0.001). There were significant decreases in the frequency of extreme pain (p < 0.001), pain with activity (p < 0.001), and pain during sleep (p < 0.001). By 6 months, patients reported their level of resting pain, the level of pain with overhead activity, and during sleep to be ‘mild’. The frequency of extreme pain was reported as between ‘monthly’ and ‘none’ and the frequency of pain during overhead activity and extreme pain decreased to ‘monthly’.These improvements in the reduction of shoulder pain severity and frequency continued over the first six months. From pre-operatively to the 6-month timepoint, there was a significant reduction in the severity of pain at rest (Patient-rated pain scores at long-term follow up (4.8 years on average) revealed ongoing significant improvements compared to pre-operative values in all components. On average, patients reported their level of resting pain, level of pain with overhead activity, and level of pain during sleep as being between ‘none’ and ‘mild’. At long term follow up, patients reported the frequency of extreme pain as ‘never’ and frequency of pain with overhead activity and pain during sleep as between ‘never’ and ‘monthly’ . PatientBetween the six-month follow-up and the long-term follow-up, the level and frequency of pain experienced by patients during overhead activity and during sleep were reduced significantly .There were 26 patients (27 shoulders) out of the 31 (33 shoulders) who attended long term follow-up for shoulder assessment and examination of range of motion.p = 0.002), forward flexion . The range of internal rotation had improved on average from vertebral level T12 (range L1 to T11) to T10 (range T11 to T9) (p = 0.013). There was also a trend of improvement in external rotation range of motion over this time period .From pre-operative to long-term follow-up (~4.8 years), patients demonstrated statistically significant increases in the range of motion  of abducp = 0.002). The external rotation had also improved from 48° ± 5° to 66° ± 4° (p = 0.03).When comparing between six-month follow-up and long-term follow-up, the abduction range improved significantly from 148° ± 7° to 161° ± 6° (p < 0.001). There were statistically significant reductions in patient-reported stiffness from pre-operatively to 6 weeks (p = 0.01), pre-operatively to 12 weeks (p = 0.01), pre-operatively to 24 weeks (p = 0.003), 6 weeks to 12 weeks (p = 0.002), and from 6 months to long term follow up (p = 0.003).With regards to patient-reported stiffness, patients experienced the highest levels of stiffness pre-operatively, and stiffness levels trended downward over time. Pre-operatively, patients reported their stiffness ranging on average from “moderate to quite”. By long-term follow-up, the average stiffness level was “none to a little”, a statistically significant difference  reported their shoulder as stiffer at long-term follow-up compared to pre-operatively; this patient’s stiffness level had increased from “a little” stiff to “moderately” stiff.A total of 26 patients (27 shoulders) out of 31 patients (33 shoulders) completed the strength-testing follow-up.p = 0.005), and from preoperatively to long term follow-up (50 ± 5 N) (p = 0.02), but no difference from 6 months to long-term follow-up (p = 0.98).There was improvement in strength  on testiWith regards to abduction, internal rotation, and lift-off, there were no significant differences in strength from pre-operatively to post-operatively at all timepoints.p = 0.04), however, there was no significant difference between pre-operative and long-term external rotation strength . There was no significant difference between strength at 12 weeks and strength at long-term follow-up .External rotation strength improved from pre-operatively to 12 weeks , 24 out of 27 (89%) re-imaged shoulders had no residual calcifications at long-term follow-up. There were one (4%) medium-sized (5–15 mm) and two (7%) small-sized (<5 mm) residual calcium deposits that were identified. A total of 26 shoulders out of 27 (96%) images had intact rotator cuffs at a mean of 4.8 years of follow-up. One shoulder out of 27 (4%) imaged had a 10 mm × 10 mm 90% undersurface tear of the supraspinatus at long-term follow-up that required secondary ipsilateral surgery.There were no intra-operative complications in the 31 patients (33 shoulders). One male patient experienced a wound infection at one-week post-operative and was treated with arthroscopy of the sub-acromial space, wound incision, and debridement in addition to antibiotics. There was no development of post-operative osteoarthritis or shoulder instability in the ipsilateral shoulder noted during the study period.This study validated the efficacy of arthroscopic debridement of calcific tendonitis with localization assistance from a breast biopsy needle under ultrasound guidance. Patients experienced significant improvements within the first week post-operatively with regards to shoulder function and pain and continued to make further improvements until a mean post-operative time of 4.8 years.Our results provided further evidence of the short-term effectiveness of this procedure. By only one week post-surgery, patients reported significant reductions in pain severity at rest and during sleep, as well as reduced frequency of pain during sleep and reduced frequency of extreme pain. By 6 months post-operatively, patients in our study, on average, reported “mild” shoulder pain on a “monthly” basis, whereas pre-operatively, patients experienced pain either daily or always, and of moderate to severe intensity. These findings of the short-term effectiveness of this technique were consistent with those of Kelly et al. , who alsBy long-term follow-up (mean 4.8 years), patients demonstrated dramatic improvements in all of the study’s measurements of pain severity and frequency, function, overall satisfaction, and stiffness compared to pre-operatively. Furthermore, they also experienced improvements in almost all measures of range of motion compared to pre-operatively, except for external rotation, which was un-changed. Notably, patients continued to show further improvements between the 6-month mark and the long-term follow-up with regards to range of motion , subjective stiffness, pain frequency (during sleep and during activities), and pain severity (during sleep and during overhead activities).This technique was associated with the preservation of the long-term structural integrity of the rotator cuff. Within the study group, 22 patients out of 33 also had concurrent rotator cuff repairs. However, by long-term follow-up, only 1 out of 27 (4%) shoulders suffered a torn rotator cuff. This figure compares favorably to arthroscopic rotator cuff repair, which has retear rates documented between 11% and 94% ,26.p < 0.001) and a constant score improving from 60 (±20) preoperatively to 87 (±15) at final follow-up (p < 0.001). However, 10 patients out of the 35 patients (29%) who did not experience any preoperative limitation to motion, developed a secondary stiff shoulder, which ultimately resolved by 3–9 months post-operatively for all patients. Their rehabilitation protocol was “similar to that of a small rotator cuff tear”, and our facility also used our rotator cuff rehabilitation protocol when a repair was performed. Our technique, utilizing a breast biopsy needle and ultrasound guidance, resulted in minimal post-operative stiffness and significant improvements in range of motion. By 6 weeks, only one patient  that did not have preoperative stiffness had developed a secondary stiff shoulder. On average, stiffness improved from “moderate to quite” pre-operatively, to “mild” at 6-month follow-up. At long-term follow-up, out of the 32 patients, only one patient (3%) reported their shoulder as stiffer at long-term follow-up compared to pre-operatively. Additionally, only one patient reported very severe stiffness (this patient had experienced very severe stiffness since pre-operatively), and one patient reported their shoulder to be “Quite” stiff . These results suggest that accurate localization of the calcium deposit with the use of the breast biopsy needle under ultrasound guidance may result in reduced stiffness post-operatively. The minimal stiffness encountered post-operatively by this technique may be explained by a more thorough removal of calcium, as secondary stiffness post-arthroscopic debridement has been thought to be due to residual calcium fragments inducing further inflammation within the surrounding structures [Yoo et al.  performeructures ,20.The substantial pain relief that this procedure provides to patients may be explained by enhanced accuracy in the removal of the calcific deposit. By long-term follow-up, none of the shoulders had any large calcium deposits remaining, only one patient had a medium-sized deposit, and two still had small calcium deposits (<5 mm) remaining. Hackett et al.  demonstrThe strengths of our study are the holistic long-term follow-up comparisons of patient-rated and examiner-rated data, radiological outcomes, and assessment via ultrasound of rotator cuff integrity. The internal validity of the study is high, with a single orthopedic surgeon and sonographer performing the surgery and follow-up assessments, respectively. This may reduce the external validity of this study. Other weaknesses include the lack of a control group. However, to find a similar group without surgical treatment with similar follow-up intervals is difficult, and administration of a placebo would, in our view, have ethical issues. The findings are only relevant to those with symptoms sufficiently severe to require/elect surgery.○Arthroscopic debridement of calcific tendonitis with localization assistance from a breast biopsy needle under ultrasound guidance is successful in removing the rotator cuff calcific deposit and maintaining the integrity the of rotator cuff tendons.○At a mean of 4.8 years, arthroscopic debridement of calcific tendonitis was successful in relieving the severity and frequency of pain with overhead activities, pain at rest, and pain during sleep.○Patients experienced significant improvements in range of motion.○Secondary shoulder stiffness was not a significant complication of this technique.This study shows that:


BackgroundSacroiliac joint dysfunction is a major cause of axial low back pain which can masquerade as pain from lumbar disc diseases. Treatment of axial back pain arising due to sacroiliac joint dysfunction remains a challenge. This study was conducted to evaluate the long and short-term effects of intra-articular corticosteroid injection in the relief of pain and disability caused by sacroiliac joint dysfunction.MethodologyA total of 83 patients with sacroiliac joint dysfunction were included in this prospective randomized control study. Patients were randomized into two groups by a computer-generated randomization table. These two groups were treated with fluoroscopy-guided corticosteroid and local anesthetic injection (group A) and distilled water and local anesthetic injection (group B). Pre and post-intervention assessment of all patients was done based on the Numeric Pain Rating Scale (NPRS) for pain and Oswestry Disability Index (ODI) for disability. The outcome measures of the study were the NPRS and ODI assessed at the initial visit one (pre-injection), two weeks post-injection (visit 2), and four weeks post-injection (visit 3).ResultsDemographic data were comparable in both groups. There was no significant difference in pre-injection NPRS and ODI values in both groups. The changes in NPRS and ODI values were significant from pre-injection to two weeks to four weeks. Group A patients performed better in terms of a decrease in the perception of pain and a decrease in the perception of disability compared to group B patients in the second and fourth weeks of follow-up.ConclusionsFluoroscopy-guided corticosteroid injection is an effective measure for reducing pain and disability in patients with sacroiliac joint dysfunction. A significant contributing factor to persistent axial low back pain is the sacroiliac joint . With agPain in the lower back and/or legs can occasionally result from sacroiliac joint dysfunction. Because they can feel very similar, it can be challenging to distinguish between radiating leg pain from a lumbar disc herniation (sciatica) and sacroiliac joint dysfunction. According to the International Association for the Study of Pain (IASP), sacroiliac joint pain is described as being exclusive to the sacroiliac joint area, reproducible through stress and provocation testing of the joint, and consistently reduced by 50% by elective local anesthetic injection of the joint [The diagnosis often starts with the collection of medical history, which includes details of the present pain and symptoms. Medical history also includes details of a person’s diet, sleeping, and physical activity routines, as well as any current or previous injuries that may have contributed to the development of sacroiliac joint pain. Gaenslen’s test, Patrick’s test, Yeoman’s test, side-lying iliac compression test, midline sacral thrust, and pressure application to the sacral sulcus while in the prone position are the provocation tests for the diagnosis of sacroiliac joint dysfunction ,7.Treatments for sacroiliac joint dysfunction (sacroiliac joint pain) usually concentrate on reducing discomfort and regaining the joint’s range of motion. The majority of sacroiliac joint pain can be treated without surgery.Initial therapies for sacroiliac joint discomfort frequently involve a brief moment of rest. Resting for more than a few days is not advised because it can exacerbate stiffness, increase pain, and lead to general deconditioning. Ice helps reduce swelling and ease pain and discomfort when administered to the pelvis and low back. For mild-to-moderate pain management, over-the-counter analgesics (such as acetaminophen) and non-steroidal anti-inflammatory drugs  can be prescribed. No single treatment works for everyone. Typically, multiple non-invasive procedures must be used to effectively relieve pain. Additionally finding medications that target particular symptoms can require a trial and error.Literature supports the use of intra-articular sacroiliac joint injections and radiofrequency thermoneurolysis for both short- and long-term relief. Sacroiliac joint dysfunction is one condition for which fluoroscopy-guided corticosteroid injections are used; therefore, evaluating the advantages of sacroiliac joint injection in patients with sacroiliac joint dysfunction/pain will expand the scope of currently available treatments for chronic low back pain and pave the way for new areas of study in the management of chronic low back pain. This prospective study was conducted to determine the efficacy of fluoroscopy-guided sacroiliac joint corticosteroid injection in the management of patients with chronic axial low back pain secondary to sacroiliac joint dysfunction/pain who presented to our center .This study evaluates the effect of fluoroscopy-guided corticosteroid injection in patients with sacroiliac joint dysfunction. In total, 83 patients with sacroiliac joint dysfunction who were age and sex-matched were assessed for eligibility. Of these, eight patients did not meet the inclusion criteria, and three patients refused to participate in the study. Hence, 72 patients were randomized into two groups by a computer-generated randomization table. Both groups were treated with fluoroscopy-guided corticosteroid and local anesthetic injection (group A) and distilled water and local anesthetic injection (group B).This prospective randomized control trial was conducted at King George’s Medical University, Lucknow, after obtaining ethical clearance from the institutional ethical board (97th ECM II B Thesis/P62) and informed consent from all patients. The study group comprised 72 subjects. Patients in the age group of 18-60 years with pain located over the sacroiliac joint principally below the L5 vertebra and satisfying the IASP diagnosis criteria of sacroiliac joint dysfunction were included in the study. Patients with spinal and pelvic deformities or disorders of the hip joint and those with allergic reactions to lidocaine or contrast media were excluded from the study. Further, patients with suspected or diagnosed infection, poor general health, skin defects in the injection area, and patients with uncontrolled diabetes were not included in this study to avoid generalized infections.Simple randomization was done. All patients who fulfilled the inclusion criteria and gave written informed consent for participation in the study were enrolled with concealed allocation method using a computer-generated system. The principal investigator generated the random allocation sequence and enrolled the participants and allowed the intervention. Regarding blinding, only the trial participants were blinded in the study.In the procedure room, patients were connected to a multi-parameter monitor to obtain baseline vital signs, and periodic cardiorespiratory parameters and venous access were secured. With patients in the prone position, the C-arm fluoroscope was placed in the anteroposterior (AP) position to visualize the L5-S1 disc space at the L5-S1 interspace. The widest space at the most inferior aspect of the sacroiliac joint was identified, and the C-arm was angled 5° in the cephalad direction and 15° in the medial direction until the lines of the anterior and posterior aspects of the joint overlapped. The needle entry point was at the inferior edge  of the joint, and confirmation of the needle was done by injecting contrast media. After confirmation, group A was injected with 1.0 mL of triamcinolone acetonide and 1 mL of 2% lignocaine. In group B, 1 mL of distilled water and 1 mL of 2% lignocaine were administered. All patients were promoted to exercise for 20 minutes three times a week for four weeks. The Numeric Pain Rating Scale (NPRS) for pain and Oswestry Disability Index (ODI) for disability were assessed at week zero  and week two (visit two) and week four (visit three) (post-intervention) during follow-up. Pre-intervention assessment of all patients was done using the NPRS for pain and ODI for disability ,10.A total of 83 patients were enrolled in the study but three refused to participate and eight did not meet the inclusion criteria; hence, 72 patients were randomly allocated to two groups of 36 each, as shown in the consort flow diagram Figure .No significant differences were found in age, gender, site, and group distribution. The outcome measures of the study were NPRS and ODI assessed at the initial visit one (pre-injection), two weeks post-injection (visit two), and four weeks post-injection (visit three) in both groups.At pre-injection, the mean NPRS in group A was 6.97 ± 0.878 and in group B was 7.28 ± 0.701. At pre-injection, group A mean ODI was 35.94 ± 0.841 and group B mean ODI was 37.08 ± 0.729. No significant difference (p = 0.107) was found between the average pre-injection NPRS and pre-injection ODI of the two groups  and 4.47 ± 1.521 in group B (p <0.001). After four weeks of injection, the mean NPRS was 3.06 ± 1.567 in group A (p < 0.001) and 5.171 ± 0.577 in group B (p < 0.001). A previous study found that the mean NPRS was 1.67 ± 0.18 (p < 0.001) after one week and 0.94 ± 0.15 (p < 0.001) after four weeks in their fluoroscopy group [In our study, we found that after two weeks of injection, the mean ODI was 19.58 ± 6.491 in group A and 24.17 ± 7.865 in group B (p = 0.009), and after four weeks of injection, the mean ODI was 18.14 ± 8.932 in group A and 29.06 ± 8.003 in group B (p < 0.001). A previous study found that the mean ODI was 27.50 ± 0.86 after four weeks (p < 0.001) in the fluoroscopy group [In our study, we have demonstrated that fluoroscopy-guided corticosteroid injection in patients with sacroiliac joint dysfunction is effective for up to one month of follow-up period compared to the placebo group. This randomized controlled trial reported improvements in each of the two treatment groups over the course of the study, suggesting some degree of efficacy of both treatments. Improvements in both groups were seen when assessed by the NPRS and ODI scores. Our study showed that this intervention, i.e., fluoroscopy-guided sacroiliac joint injection, not only reduces pain but also decreases disability and gives clinicians a proven efficacious short-term treatment for patients with sacroiliac joint dysfunction/pain.LimitationsAlthough the experienced clinician may have controlled the location of the needle probe, the free-hand technique used for intra-articular delivery may have affected the results of this study. This study is a single-blinded randomized controlled trial study and could have been a double-blinded randomized controlled study. With respect to the findings of our study, these limitations make it advisable to design future studies that consider low effect sizes and long-term follow-ups, as well as include larger sample sizes.There was a significant improvement in low back pain due to sacroiliac joint dysfunction after fluoroscopy-guided corticosteroid injection for the duration of one month, as reflected by the decrease in the NPRS at two weeks and four weeks post-injection follow-ups. Despite limited evidence of long-term effectiveness, corticosteroids have been shown to be more effective in short time periods, as shown by a significant reduction in NPRS and ODI values in group A participants in comparison to that in group B participants.


This study demonstrates that opioid switching is effective at reducing pain, adverse effects, and psychological distress to satisfactory levels of symptom control within 1 week in a population with advanced cancer pain. The use of multidimensional tools and standardized reporting further adds to the quality of evidence supporting opioid switching practice.Opioid switching is the practice of substituting one opioid for another to improve pain relief or reduce adverse effects. This study aimed to examine pain and adverse event outcomes in people with advanced cancer pain, comparing those who undergo opioid switching with a control group, using multidimensional pain and standardized adverse event recording to add toward the limited data on this common practice. We found that compared to the control group, opioid switching reduced pain  (p < 0.05), uncontrolled breakthrough pain , and psychological distress . The switch group had a ≥25% reduction in the reported frequency of seven moderate-to-severe adverse effects (score ≥ 4), compared to a reduction in only one adverse effect in the control group. The control group experienced no significant pain differences at the follow-up. Opioid switching is effective at reducing pain, adverse effects, and psychological distress in a population with advanced cancer pain, to levels of satisfactory symptom control in most patients within 1 week.Opioid switching is a common practice of substituting one opioid for another to improve analgesia or adverse effects; however, it has limited evidence. This study aimed to examine the effectiveness of opioid switching in advanced cancer. This multi-center prospective cohort study recruited patients assessed to switch opioids (opioid switch group) or to continue ongoing opioid treatment (control group). Clinical data  and validated instruments (pain and adverse effects) were collected over two timepoints seven days apart. Descriptive analyses were utilized. Non-parametric tests were used to determine differences. Fifty-four participants were recruited . At the follow-up, opioid switching reduced pain  ( Pain affects two-thirds of people with advanced cancer  and is oObservational data suggest opioid switching to be beneficial ,6,9,10; To address the limitations of previous work, this study aimed to compare a cohort of people with cancer pain who undergo opioid switching, with a comparator control group in a prospective longitudinal study. The characteristics of each group are carefully described, with information recorded for cancer type, pain experienced, opioid administered, psychosocial outcomes, adverse effects (AEs), and hematological and biochemical data, to satisfy a multidimensional assessment of the effects of opioid switching compared to those on controls using standardized and validated tools.Design and Population: This multi-center prospective open cohort study included adult patients with pain from advanced cancer who were known to palliative care services and had received stable doses of slow release (SR) opioids to manage pain for at least three days before enrolment. Participants were recruited into two groups—(1) the Switch Group, in which patients were deemed to require a switch in SR opioids for any reason at enrolment, and the (2) Control Group, which included patients on a stable SR opioid dosing regimen. For those in the switch group, the requirement for an opioid switch was based on the decision of the attending palliative care physician, with reasons for the switch being documented. Patients were included from five tertiary metropolitan hospitals with cancer and palliative care services in Victoria, Australia, from April 2019 to May 2020. The study was approved by the St Vincent’s Hospital Melbourne Ethics Committee (HREC 252/18). All participants provided written informed consent to participate in the study.Data Collection: Data were collected at the baseline (T0), and again 7 days later (T1) in order to provide adequate time for observation and to reflect plasma opioid steady-state conditions for the switch group. The control group received the same SR opioid at both timepoints; however, the dose was dependent upon clinical requirement at each timepoint (T0 and T1). The switch group received the final dose of their initial SR opioid at T0, after which their SR opioid was switched, and data were collected 7 days later (T1).The collected data included demographics, clinical and cancer characteristics, the Charlson comorbidity score , opioid Pain characteristics were assessed using patient-reported questionnaires (Brief Pain Inventory–Short Form (BPI-SF) , self-rep < 0.05) differences were found, the 95% CI of differences was calculated. An analysis plan was generated a priori to enable the standardized coding of descriptive data into relevant categorical and/or numerical variables for inclusion in the result tables. Median values or scores were used to reduce the effect of outliers. Analysis was undertaken using R Statistical Package (version 4.0) [Analyses: Descriptive statistics were used to report all measures. Continuous variables were expressed as medians with interquartile ranges (IQR) and categorical variables as counts (N) and percentages. Wilcoxon’s signed-rank test and McNemar’s test were used to determine differences in scores for pain, adverse effects, and associated symptoms between T0 and T1 within both groups. Conditions in which the sample size was fewer than ten discordant pairs were excluded from hypothesis testing as this did not meet the minimum sample requirement for the McNemar test . The midion 4.0) .The study comprised 54 patients who had cancer-related pain, with 23 control group and 31 switch group participants . The medp = 0.41)  . The mos = 0.41) . The mosBased on clinician assessment, all patients in the switch cohort underwent opioid switching due to uncontrolled pain, with seven (21%) also having an opioid-related adverse effect, most commonly constipation, followed by nausea with fewer patients reporting itch, hallucinations, sedation and myoclonus.p = 0.008) and more frequent breakthrough pain  than patients kept on stable opioid therapy. Post-switch, a statistically significant one-point improvement was observed in almost all of the pain questions , and also in several domains for the influence of their pain on function . There were also statistically significant reductions in daily breakthrough pain frequency  and those experiencing ≥4 breakthroughs per day  (p < 0.005).Patients who were assessed to be in need of an opioid switch had higher scores for worst pain  . Clinicip > 0.05) improvements in pain relief percentages and in the non-pain domains. The control group had no statistically significant differences in pain scores between T0 and T1  is reported in p < 0.05). The absolute scores of AEs are given in The commonest uncontrolled patient-reported symptom at the baseline was tiredness . For each symptom, the switch group had at T0 more participants with uncontrolled symptoms, and these were statistically significant for nausea, tiredness, drowsiness, depression, and itch (p = 0.003), and anxiety in the control group . The NUDESC and MDAS scales showed that all patients did not have delirium at either timepoint. The Clinical Global Impression of Change is not reported due to missing data.In the switch group, participants reported a ≥25% reduction in the frequency of 7 of the reported moderate–severe symptoms at T1 , whereas in the control group, only one symptom (anxiety) was reduced by a similar factor. Statistically significant reductions were seen in tiredness in the switch group  patients were reported to undergo opioid switching due to intolerable AEs, with minimal differences seen post-switch. Similarly, a systematic review found that AE frequency only rarely lessened post-switch, but also pointed out that AEs were inconsistently measured in opioid switching studies. Various studies have reported either a small (25–34%) ,39,40 orThe degree of association between each adverse effect and opioids can be difficult to measure, as patients with advanced cancer can have multiple, inter-related and multifactorial symptoms. Symptoms may be caused by the cancer itself, anti-cancer treatments, other chronic non-cancer conditions and opioids. Some studies have included any patient-reported symptom that could possibly be an opioid AE  as opioid-related ,41,43. AWe recognize several limitations to this study. First, it was unblinded and the patients were not randomized. Still, the observations reflect daily clinical practice in the selection of patients for an opioid switch and the results from the switch. Second, a larger sample size would have afforded more statistical power to determine definitive associations and conduct subgroup analyses for various opioid switch pairs on the degree of pain type , oMEDD, and AEs. Nevertheless, our sample of 58 participants in total is larger than that of most studies on opioid switching and has demonstrated statistically significant differences across various clinically important pain and non-pain outcomes. Finally, other factors than the opioid switch may have influenced changes in the seven-day follow-up period. However, since the time interval between timepoints was only 7 days, it is likely that these symptoms improved as a result of opioid switching. This is supported by the presence of stable symptoms in the control group.This study shows that opioid switching is effective for a population of cancer patients undergoing palliative care who have severe pain that is refractory to their current opioid use. Opioid switching improved background and breakthrough pain to satisfactory control levels within 1 week. This study also assessed and found improvements in multiple dimensions related to pain, namely psychological distress, AEs, and functional ability scores which improved to levels similar to those of patients who were comfortable on their baseline dose of an opioid (the control group).Future directions should include the ascertainment of larger patient cohorts and a focus on more homogeneous patient groups in a smaller number of opioid types. Sub-group analyses would then be powered to investigate different opioid switch pairs to investigate reasons for certain opioids being preferred for certain groups of people. A longer follow-up period could determine the degree of long-term success of opioid switching, and whether or not the strength of its effectiveness remains over subsequent switches, which could allow for the pre-emptive “prognostication” of the likely requirement for opioid switching, which may alter how closely these patients are clinically monitored. The addition of pharmacokinetic and genomic testing will further strengthen the ability to carry this out. A standardized assessment of AEs that combines both clinician and patient-reported outcomes may reduce the large variability in AE reporting.


Management of acute postoperative pain is one of the major challenges in pediatric patients. Oral oxycodone has shown good pain relief in postoperative pain relief in children, but no studies have investigated intravenous oxycodone in this context.whether oxycodone PCIA can provide adequate and safe postoperative pain relief, in comparison to tramadol as reference opioid drug.a randomized, double-blind, parallel, multi-center clinical trial.five university medical centers and three teaching hospitals in China.patients aged 3-month-old to 6-year-old undergoing elective surgery under general anesthesia.–1, respectively), then with a parent-controlled intravenous device with fixed bolus doses only , and a 10-min lockout time.patients were randomly allocated to either tramadol (n = 109) or oxycodone (n = 89) as main postoperative opioid analgesic. Tramadol or oxycodone were administered with a loading dose at the end of surgery  score < 4/10 in the post-anesthesia care unit (PACU), with no need for an alternative rescue analgesia. FLACC was measured 10 min after extubation then every 10 min until discharge from PACU. Analgesia was currently conducted with the boluses of either tramadol or oxycodone if FLACC was ≥ 3, up to three bolus doses, after what rescue alternative analgesia was administered.tramadol and oxycodone provided a similar level of adequate postoperative pain relief in PACU and in the wards. No significant differences were either noted for the raw FLACC scores, the bolus dose demand in PACU, the time between the first bolus dose and discharge from PACU, analgesic drug consumption, bolus times required in the wards, function activity score, or the parents’ satisfaction. The main observed side effects in both groups were nausea and vomiting, with no difference between groups. However, patients in the oxycodone group showed less sedation levels and had a shorter stay in the PACU, compared with the tramadol group.an adequate postoperative analgesia can be achieved with intravenous oxycodone, this with less side effects than tramadol. It can therefore be a choice for postoperative pain relief in pediatric patients.www.chictr.org.cn .The study was registered at  Question: Can the intravenous administration of oxycodone provide adequate postoperative analgesia in children?Findings: Oxycodone can provide well postoperative pain control in children, similar to tramadol.Meanings: For the first time, we demonstrate that administration of oxycodone intravenously can provide well acute pain control in children after surgery, expanding our opioid drug choice for postoperative pain management in children patients. Acute postoperative pain is one of the major challenges for the anesthesiologists . A studyCompared to adults, children should receive analgesia through the most comfortable and least painful method available. The oral administration of analgesics is straightforward and has demonstrated good effectiveness in various settings. However, the oral route is often unsuitable for postoperative pain relief immediately after surgery due to the risk of nausea and vomiting or a slow return to normal gastric function . As a reMorphine is the most widely utilized opioid in PCA for children in western countries and serves as the benchmark against which other analgesics are evaluated in clinical trials . Other cOxycodone stands out among analgesics as a full agonist of both µ- and κ-opioid receptors , 10, offIn this study, we propose that oxycodone-based PCIA can provide postoperative pain relief in pediatric patients effectively and safely. We chose not to use morphine as a positive control due to its low acceptance rate of only 14.8% among pediatric patients in China, compared to higher rates for sufentanil 70.4%), fentanyl (66.7%), and tramadol (59.3%) . Sufenta0.4%, fenwww.chictr.org.cn . The registration information was updated on 06/Jan/2023 because of an English typing mistake, which caused a discrepancy in the Chinese version and the English in the inclusion criteria . The registration office has amended the English mistake after carefully checking all the original registration documents. We conducted a multi-center clinical trial in the Second Affiliated Hospital of Xi’an Jiaotong University , Henan Children’s Hospital & the Third Affiliated Hospital of Zhengzhou University , Wuhan Children’s Hospital, Tongji Medical College, Huazhong University of Science & Technology , Hunan Children’s Hospital , Zhumadian Central Hospital . The Good Clinical Practice guidelines and the guidelines of the Helsinki Declaration were followed in the study.This is a randomized, double-blind, parallel, multi-center clinical trial. This study was approved by the medical ethics committee, the second affiliated hospital of Xi’an Jiaotong University (2018024), and written informed consent was approved by each patient’s legal guardian. The study was registered at 2 and American Society of Anesthesiologists (ASA) I-III] undergoing major surgery including general, urinary, and orthopedic surgery under general anesthesia were recruited. Patients were excluded if they met any following criteria: schizophrenia, epilepsy, infantile autism, attention deficit hyperactivity disorder, myasthenia gravis, cerebral palsy, Down’s syndrome, coma, and any other brain injury or neurosurgery; taking monoamine oxidase inhibitors within 2 weeks before the surgery; children may ingested alcohol or narcotics for various reasons, including medication and family influence; diabetes; severe hepatic, renal, pulmonary dysfunction; congenital heart disease or other congenital malformation; prematurity; any other diseases potentially interfering study results; surgery shorter than one hour; incomplete case report form (CRF).Patients [3-month-old to 6-year-old, Body Mass Index (BMI) 18-29.5 kg/mhttps://pan.baidu.com). As new participants consented to join the study, the responsible anesthesiologist would contact the biostatistician, who would assign the participant to either group A or B based on the next unused random number from the online sequence. This allocation was marked as used in red.A biostatistician who is unaware of treatments and patient follow-up, generates the random numbers using the SAS software  in a ratio of 1:1, named group A and group B. The randomization sequence is stored online until the end of the study , pulse oximetry (SpO2), heart rate (HR), noninvasive blood pressure (NBP), and bispectral index (BIS), was established before induction of general anesthesia, which was achieved through administration of 3 mg.kg–1 propofol, 0.2 mg.kg–1 cisatracurium, and 0.4 µg.kg–1 sufentanil. During the surgery, propofol (6-10 mg.kg–1.h–1) and remifentanil (0.1–0.3 µg.kg–1.min–1) were administered through continuous infusion, with adjustments maintaining BIS between 40 and 60 and blood pressure and/or heart rate alteration within 20% of baseline. Cisatracurium was maintained at a rate of 2 µg.kg–1.min− 1.Patients were fasting from clear liquids for 4 h and solid food for 6 h prior to undergoing anesthesia. No analgesic or antiemetic drugs were administrated before the procedure. Thirty minutes before the procedure, patients received an intramuscular administration of 0.01 mg.kg–1 ketorolac tromethamine, 0.1 mg.kg–1 dexamethasone, and 0.1 mg.kg–1 tropisetron were administrated intravenously. Upon completion of surgery, patients received intravenous administration of oxycodone (0.1 mg.kg–1) or tramadol (1.0 mg.kg–1) 18, followed by the administration of the PCIA without background infusion. The bolus dose was 0.05 mg.kg–1 for the oxycodone group and 0.5 mg.kg–1 for the tramadol group each time, with a lockout time of 10 min for all patients. Surgical time, consumption of sufentanil and remifentanil, incision length, and hemorrhage volume during surgery were recorded.Cisatracurium infusion was discontinued 30 min prior to the end of surgery, and 0.5 mg.kgAfter surgery, all patients were transferred to the post-anesthesia care unit (PACU). Extubation was performed after full recovery of spontaneous ventilation and consciousness. Ten min after extubation, pain intensity was firstly evaluated using the face, legs, activity, cry, consolability (FLACC) scale , followe2 < 90% (breathing room air) or < 92% .Postoperative follow-up inwards was performed by research personnel or a healthcare member who was blinded to the allocation of the patient. Postoperative intensity at rest was evaluated using the FLACC scale by the parents. A bolus dose was given to the patient by parents immediately if the FLACC score was above 3. All parents were instructed on how to use the FLACC scale to evaluate postoperative pain intensity by research personnel face to face until they completely understood the method. Pain intensity in response to turning around in bed was evaluated using the functional activity score (FAS) . BrieflyOutcome assessment was performed by researchers who were kept blind to the patient’s group assignments. The primary outcome was whether oxycodone could provide adequate postoperative pain relief after surgery in pediatric patients. The definition of adequate postoperative pain relief includes (1) the FLACC score< 4 in the PACU; (2) patients do not need alternatively rescue analgesia. Ten minutes after the extubation in the PACU, postoperative pain in PACU was firstly evaluated by research personnel unaware of the allocation of the patient according to the FLACC scale; the FLACC evaluation was repeated every 10 min until discharge from PACU. A bolus dose of oxycodone or tramadol is given to the patient immediately if the score ≥ 4 according to patient’s allocation. The procedures could be repeated after 10 min until the score ≤ 3. If postoperative pain relief is not satisfied after three continuous bolus doses, alternative rescue analgesia is administrated to the patient.The secondary outcomes included No. of boluses administered and bolus-administered amount of opioid in PACU  in PACU and in the wards, time spent from PACU discharge to the first bolus dose, bolus analgesia rate in the wards, FAS scores in the wards, parents’ satisfaction with the PCIA. We also recorded and analyzed the consciousness recovery time, extubation time, the length of staying PACU, Ramsay scores, and adverse events, especially hypoxemia.A pilot observational study in our center showed that the FLACC scores between the oxycodone and tramadol groups in PACU were 3.71 ± 1.71 and 4.49 ± 1.74, respectively. The sample size required was 166 patients (83 patients in each group) after calculation with two-tailed α = 0.05 and β = 0.2 using the SAS software . Considering the possible dropout cases, we increased the sample size to 240 for initial enrollment.GraphPad Prism 6.0 software  was used to perform the statistical analysis. The per-protocol analysis set consists of subjects who were randomly assigned to treatment, and have no major protocol violations such as violations of entry criteria, errors in treatment assignment and use of excluded medications. Gaussian distribution was tested using D’Agostino & Pearson analysis. Data was displayed as the median value (1st -3rd quartiles). An unpaired t test  or Mann-Whitney u test  was used to analyze the numeric variables. FLACC scores, Ramsay sedation scores, and parent satisfaction scores were analyzed using a linear mixed-model to analyze the interaction and main effects of time and group. χ2 test or Fisher exact probability method  was used to analyze the categorical variables were analyzed. A significant difference was defined as a value of P < 0.05.From October 2018 to September 2019, 240 patients were screened and 21 of them were excluded  after extubation in PACU, and there was no significant difference in FLACC scores at 10 min, 20 or 30 min after extubation  after the bolus dose administration, and no alternative rescue analgesia was thereby recorded. There was no significant difference in the FAS scores (in response to turning around in bed), incidence rate of bolus analgesia, time spent from PACU discharge to the first bolus dose, No. of boluses administered, bolus-administered amount of opioid  in the wards between the oxycodone and tramadol groups , 24 h (P = 0.553) or 48 h (P = 0.834) after surgery . Interestingly, patients from the oxycodone group showed significantly lower Ramsay sedation scores relative to the tramadol group 10 and 20 min after extubation in PACU Fig. .We further compared the other PCIA-related adverse events in the wards. As shown in Table There are several reasons for the cautious use of opioids in pediatric postoperative pain management, one of which is the fear of potential severe adverse effects due to children’s young age and small size. Although oral oxycodone has been widely used for pain relief in children, there is no literature on the use of intravenous oxycodone for postoperative pain relief in pediatric. In this study, we investigated whether intravenous oxycodone can provide adequate and safe postoperative pain relief, in comparison to intravenous tramadol which has a well-established use in children .Oxycodone elimination is slower and its pharmacokinetics are more variable in neonates, particularly preterm newborns, and thus a lower dose with a longer dosing interval is recommended in these patients . PreviouOur study showed that children patients administrated with an equal dose of oxycodone or tramadol did not show any difference in the FLACC scores after extubation, the requirement for rescues analgesia in PACU. These results suggest that oxycodone could provide adequate transition analgesia compared with the equal dose of tramadol immediately after surgery, in line with previous studies conducted in adults –28. Our After returning to the wards, we did not record any requirements for the alternative rescue analgesia in either oxycodone or tramadol groups, suggesting that both oxycodone and tramadol-PCIA provide adequate postoperative pain control in children patients. Additionally, there was no significant difference in the bolus dose administration, including bolus dose times, the anesthetics consumption equivalent with morphine, the length between the first bolus dose and the discharge from PACU, and FAS scores between the two groups, demonstrating that oxycodone and tramadol have similar efficacy in providing postoperative analgesia in pediatric patients. Differently with the period of staying in PACU, we did not observe any cases of oversedation or significant differences in Ramsay scores between the oxycodone and tramadol groups in the ward. Considering the much lower dose administrated during PCIA infusion in the wards compared with the loading dose at the end of surgery, this result further illustrated that the higher sedation effect of tramadol relative to oxycodone observed in PCAU was dose-associated.Our results align with previous studies that show that nausea and vomiting (PONV) is the most frequently reported adverse effect in both the oxycodone and tramadol groups , 29, 30.–1 oxycodone were administrated intravenously to children after major surgery respectively, and 0.15 mg.kg–1 oxycodone showed superior pain relief to 0.1 mg.kg–1 oxycodone. Therefore, it is important to conduct further research to determine the efficacy and adverse effects of different doses of oxycodone in children after surgery to meet the needs and expectations of patients and their parents. Additionally, the sample size in this study is small, making it challenging to accurately compare the incidence of adverse effects between oxycodone and tramadol. It is premature to conclude that oxycodone is better tolerated than tramadol at a similar level of analgesia, as more research with a larger sample size is needed to assess the efficacy/intolerance balance in children between these two drugs. Thirdly, the administration of either oxycodone or tramadol via PCIA may introduce potential bias due to parents’ training and understanding of postoperative pain management and evaluation systems such as NRS and Ramsay sedation scale. Finally, we did not include morphine as a control group in this study due to its low usage as a postoperative analgesia among children patients in China (14.8%), with sufentanil (70.4%), fentanyl (66.7%), and tramadol (59.3%) being the most commonly used opioids for PCIA [This study has several limitations that need to be considered: firstly, we administered only a single dose of either oxycodone or tramadol. In another preliminary study we performed, 0.05, 0.1, and 0.15 mg.kgfor PCIA . HoweverIn conclusion, our findings indicate that an adequate postoperative analgesia can be achieved with intravenous oxycodone, this with less side effects than tramadol. It can therefore be a choice for postoperative pain relief in pediatric patients.


Furthermore, sex (p = 0.011), social status (p = 0.003), and number of chronic diseases (p = 0.002) were significantly associated with the pain interference score. Additionally, Person’s test indicated significant correlations between CRP and pain severity (p < 0.001) and with pain interference (p < 0.001). Albumin was significantly and negatively correlated with pain severity (p = 0.001) and pain interference (p < 0.001). Multiple linear regression analysis revealed that patients who had a higher CRP level and many chronic diseases were more likely to have a higher pain severity score. However, pain severity was the only predictor for pain interference. Our results suggest that there is a significant correlation between the existence of chronic pain in hemodialysis patients and increased CRP levels. However, further investigations are needed with a larger number of patients in more than one dialysis unit to confirm this correlation and management of chronic pain in patients with HD.End-stage renal disease (ESRD) is a common chronic disease worldwide that requires hemodialysis. Patients may face chronic pain and poor quality of life. Therefore, a better understanding of these variables in hemodialysis patients is essential to provide a good intervention. We aim to determine how common chronic pain is in hemodialysis patients and its correlation with sociodemographics, C-reactive protein (CRP), calcium, phosphorus, albumin, and parathyroid hormone. A cross-sectional study of hemodialysis patients was conducted in Palestine. Data collection took place between November 2020 and May 2021. We used the brief pain inventory score to assess chronic pain, and lab tests detected CRP levels. Data were collected using a convenience sampling technique. There were two hundred sixty-one patients in the present study. The mean age of the patients was 51 years, with 63.6% being men. 47.1% of them reported having chronic pain. Gender ( Patients with CKD receive integrated care, including kidney replacement therapy (KRT), which can be dialysis or kidney replacement, and non-KRT conservative care2. Almost 90% of patients receiving hemodialysis (HD) are considered the most common kind of KRT3. Hemodialysis is used primarily to treat acute and chronic renal failure that has not responded to conventional medical therapy4. Despite the great importance of hemodialysis in treating ESKD, hemodialysis has many side effects in these patients. Patients who receive chronic hemodialysis sessions regularly may develop a range of consequences, including intradialytic cardiovascular instability, malnutrition, and vascular access problems4. Furthermore, there is growing evidence of the correlation between hemodialysis and chronic pain among these patients5.End-stage renal disease (ESRD) or chronic kidney disease (CKD) is a term that refers to all stages of renal impairment, from damaged at risk to mild, moderate, and severe chronic kidney failure6. Pain in patients with HD is usually moderate to severe. Neuropathic, visceral, somatic, neuropathic, nociceptive, and complicated regional pain syndromes are all factors that contribute to pain7. A study in patients with HD showed that 55% had severe pain in the previous day, and three-quarters of them reported inadequate pain management5. Psychological difficulties, disturbed sleep, lower dialysis compliance, and a decreased quality of life can all be due to inadequately controlled pain in patients with HD10. In addition, chronic pain was reported to be strongly associated with all-cause mortality in CKD patients11.Pain is described as a physically or emotionally uncomfortable experience that can lead to impotence, low physical activity, anxiety, and interruptions in tasks and social relationships12. Importantly, disturbed parameters such as calcium, vitamin, parathyroid hormone, and CRP were significantly related to chronic pain in patients with HD13. However, certain articles did not show a significant difference in the level of CRP between patients with/without pain11. These debates urge the need to explore more about this issue, as recommended by a recent study10.C-reactive protein (CRP) is an indicator of the underlying inflammatory process in ESRD; it is also a precise objective measure of inflammatory activity, accurately reflecting the production of proinflammatory cytokines, including tumor necrosis factor-a (TNF-a) and interleukin (IL-6)15. Nevertheless, no single study has emphasized the prevalence of chronic pain in hemodialysis patients and its correlation with reactive protein. Therefore, the primary aim of the current study was to clinically describe HD patients, detect the prevalence of chronic pain among them, and determine the variables influencing the prevalence of chronic pain in hemodialysis patients. In addition, our secondary aim was to detect whether there is a correlation between laboratory tests ) and chronic pain.Some studies on HD patients in Palestine were conducted and published regarding the use of complementary and alternative medicaine and the quality of life of this populationThis research will help to conduct further research on hemodialysis patients with chronic pain and to provide recommendations that can help hemodialysis patients control chronic pain, which leads to a higher quality of life. Furthermore, this study will provide new data on the value of chronic pain among hemodialysis patients and its relationship with CRP levels, which will help better understand the factors that affect chronic pain in patients with HD.A cross-sectional design was adopted to achieve the objectives of the study. Data collection took place between November 2020 and May 2021.The research was carried out at An-Najah National University Hospital in Nablus, Palestine. The hospital has a specialized dialysis unit that treats more than 300 patients.16. The sample size for this study was calculated using the Raosoft sample size calculator, with a 350 HD population, a 50% expected response, a 95% confidence interval, and a 5% error margin. The minimum number of patients required in this study was 184 HD patients. We recruited and interviewed 280 patients using convenience sampling.According to the report of the Palestinian Ministry of Health for 2019, An-Najah National University Hospital had 350 registered patients who were receiving dialysis on a regular basisAll hemodialysis outpatients who had been on dialysis for at least eight weeks, were aged over 18 years, and had completed the Institutional Review Board's consent form were chosen to participate in our study. Patients who were mentally or physically unable to communicate with the interviewer were excluded.The data collection tool used contained three parts. Part 1 consisted of sociodemographic factors, including sex, age, occupation, residency, smoking status, education level, monthly income, and marital status. Part 2 contained the clinical status of the patients, including the number of hemodialysis sessions per week, the number of years of dialysis, body mass index (BMI), the number of chronic diseases, the number of medications used, and CRP value. The CRP levels from either serum or plasma fluid were analysed using the particle enhanced immunoturbidimetric assay method. Weight before and after dialysis is probable, thus affecting BMI. Therefore, the dry weight of the patients was measured.17. We were granted authorization to use the validated Arabic version of the short form BPI that the MD Anderson Cancer Center offers20. The BPI scale uses basic numeric rating scales (NRS) ranging between zero and ten. It defines pain as follows: worst pain: 1 – 4 indicates mild pain; worst pain: 5 – 6 indicates moderate pain; and worst pain: 7–10 indicates severe pain. The BPI asks patients to rate their pain when they take the questionnaire. This is because pain levels are susceptible to change throughout the day. In addition to the former, the respondent must describe the pain level they had felt in the previous week, ranging between worst, least, and average. The BPI (short form) is a 9-point questionnaire focused on pain and related issues.In the third part, we included an instrument for measuring pain. It was the Arabic version of theBrief Pain Inventory (BPI), which is a well-known tool for measuring pain in terms of its intensity (sensory dimension) and how much it interferes with the patient’s life (reactive dimension)The Statistical Package for Social Sciences program version 15 (SPSS) was used to enter and then analyse the data. Frequencies (percentages) were used to represent categorical variables. The medians (lower–upper quartiles) were used to represent variables that were not normally distributed. The normality of the variables was determined using the Kolmogorov‒Smirnov test. The Mann‒Whitney and Kruskal‒Wallis tests were used to test for differences in medians. Pearson's correlation was applied to test the relationship between CRP and pain scores. Furthermore, we performed multiple linear regression analyses for all significant variables. A P value < 0.05 was selected as the significance number.of An-Najah National University and local health authorities approved all aspects of the study procedure on 24th November 2020 (Ref: Med. Nov. 2020/27). Permission from An-Najah National University Hospital was given to facilitate data collection. Additionally, all participants who agreed to participate in this study provided consent. We confirm that the gathered information was only used for research, and the provided data will be confidential and only be used for this research. An informant constant was given to all participants that confirmed the privacy of the data and that all the data would be secret and used only for research purposes. Because we did not collect any identifying information during the interview and our study did not pose a major risk to participants, the IRB of An-Najah National University waived the requirement for written informed consent. Therefore, the IRB of An-Najah National University approved only verbal informed consent from study participants. We confirm that all experiments and methods were performed in accordance with relevant guidelines and regulations.The Institutional Review Board (IRB) In total, 280 patients were asked to participate in the survey, and 261 accepted and were included in the definitive analysis . The average age of the patients was 51 years, with 74.3% of the participants over 50 years old. Males 63.6%, married 77%, and city dwellers 46.4% made up the majority of participants. The subjects' unemployment rate was high, 84.7%, and 61.7% of them had an income of less than 2000 New Israeli Shekels (1 NIS = 0.30 US dollars) per month. Only 10.7% of participants were without an educational degree. Regarding the variables related to dialysis, 68.2% received dialysis for less than four years, and 92.7% underwent three sessions per week. Most of them (91.2%) spent more than four hours in each session. Only 8.8% of the participants had previously undergone a kidney transplant. Almost half of the 47.9% had three or more chronic comorbidities, but most of them (82%) were on four or more chronically used medications. Finally, 24.5% are current smokers. The mean ± SD for CRP, albumin, calcium, phosphorus and parathyroid hormone was 14.6 ± 23.4, 3.6 ± 0.5, 8.7 ± 0.9, 4.7 ± 1.5, and 451.6 ± 453.7, respectively. The personal, social, and clinical information of the patients is attached in Table Approximately (47.1%) of the participants expressed chronic pain. Most reported pain in the lower back region (14.9%). However, approximately 13% had foot pain, 10.3% complained of upper arm pain, 11.5% had knee pain, 6.5% had thigh pain, 6.5% had chest pain, 6.1% had upper back pain, 5.4% had abdominal pain, and 5% had neck pain. 69.9% of the patients mentioned above reported using pain relief medications, most commonly paracetamol. In addition, approximately 12% of HD patients had pain at two sites, and 11.5% had three or more pain sites.p < 0.001), sex (p = 0.001), social status (p = 0.016), educational status (p = 0.013), and number of chronic diseases (p = 0.004) were significantly associated with pain severity score. Uneducated patients had the highest median severity score, 14.5 (0.75–20), among other groups of variable educational status. Patients with three chronic diseases had a higher median pain severity score, 6 (0–18.75), than those with fewer than three comorbidities. No significant associations were found between pain severity and dialysis-related factors such as years of dialysis, the duration of dialysis per session, and the number of sessions per week.The associations of the variables with the pain severity score are shown in Table p < 0.001), sex (p = 0.011), social status (p = 0.003), and number of chronic diseases (p = 0.002) were all significantly associated with the pain interference score. The pain interference score was 15 (0–46) for females compared to 0 (0–27.25) for males. The score was higher, 26 (0–45.75), for single social status than for married status, 0 (0–28). No significant associations were found between the pain interference score and the years of dialysis, the number of sessions per week, or the duration of dialysis per session.The associations of variables with the pain interference score are shown in Table p < 0.001), CRP (p < 0.001), and albumin (p = 0.001) and pain interference with CRP (p < 0.001) and albumin (p < 0.001). However, other laboratory parameters  were not significantly correlated with either pain score  were not considered when the CRP level was obtained, which might affect the interpretation of the current findings.Our study shows that 78.5% of patients with HD had high CRP results, and 47% had abnormal chronic pain that interfered with their lives. This work suggests a weak and significant association between chronic pain in hemodialysis patients and higher levels of CRP. However, more studies are needed with a larger number of patients in more than one dialysis unit to confirm this correlation and improve the diagnosis and management of chronic pain in patients with HD. Furthermore, it is crucial to reveal the HD patients’ other comorbid conditions and carry out a subanalysis on these populations separately.