Caitlin McCormick, Danielle Waller, Ahmed Elghzali, Logan Corwin, Tag Harris, Rachel Hazlitt, Daniel Archer, Alicia I Ford, Matt Vassar
{"title":"Assessing the completeness of safety reporting in clinical trials of regional anesthesia interventions: a registry-publication comparison systematic review.","authors":"Caitlin McCormick, Danielle Waller, Ahmed Elghzali, Logan Corwin, Tag Harris, Rachel Hazlitt, Daniel Archer, Alicia I Ford, Matt Vassar","doi":"10.1136/rapm-2025-107055","DOIUrl":"https://doi.org/10.1136/rapm-2025-107055","url":null,"abstract":"<p><strong>Background: </strong>Incomplete or inconsistent reporting of adverse events (AEs) undermines the interpretability of randomized trials. In interventional regional anesthesia (RA), where procedural risks must be clearly communicated, such discrepancies may obscure safety profiles. This study evaluates concordance between AE data reported in ClinicalTrials.gov and corresponding peer-reviewed publications.</p><p><strong>Methods: </strong>We conducted a systematic review of interventional RA trials registered on ClinicalTrials.gov with published results. AE data were extracted in duplicate across four domains: serious adverse events, other adverse events, treatment-related discontinuations, and all-cause mortality. Descriptive statistics characterized trial features. Bland-Altman and funnel plots assessed reporting concordance and bias. χ<sup>2</sup> tests compared reporting completeness by regulatory status. A composite 0-7 AE reporting score, derived from Food and Drug Administration Amendments Act Final Rule-mandated fields, was analyzed using linear and segmented regressions to identify predictors of reporting and temporal trends.</p><p><strong>Results: </strong>Among included trials, substantial discrepancies were observed in AE counts between ClinicalTrials.gov and publications. Funnel plot asymmetry suggested possible underreporting in smaller studies. Trials subject to FDA reporting requirements were significantly more likely to report complete AE data (p<0.05). Composite AE reporting scores were higher in industry-sponsored and drug-focused trials. Segmented regression identified a modest post-Final Rule increase in reporting completeness, though recent-year instability limits interpretation.</p><p><strong>Discussion: </strong>In RA trials, AE reporting is frequently incomplete or discordant across sources, with regulatory oversight linked to greater transparency. These findings highlight the need for standardized safety reporting and alignment between registries and publications to ensure accurate risk communication in anesthesiology research.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Beware of large language models for scoping literature searches.","authors":"Ryan David Williams, Reuban Butler, Leigh White","doi":"10.1136/rapm-2025-107204","DOIUrl":"10.1136/rapm-2025-107204","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145208417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sun-Kyung Park, Hansol Kim, Youngwon Kim, Young-Eun Jang, Jin-Tae Kim
{"title":"Effect of epidural anesthesia on the optic nerve sheath diameter in patients with pre-eclampsia: a prospective observational study.","authors":"Sun-Kyung Park, Hansol Kim, Youngwon Kim, Young-Eun Jang, Jin-Tae Kim","doi":"10.1136/rapm-2024-105444","DOIUrl":"10.1136/rapm-2024-105444","url":null,"abstract":"<p><strong>Introduction: </strong>Optic nerve sheath diameter (ONSD) reflects intracranial pressure and is increased in pre-eclampsia. Administrating a significant volume of epidural solution into the epidural space can potentially increase ONSD. We investigated the impact of epidural local anesthetic injection on ONSD in patients with pre-eclampsia.</p><p><strong>Methods: </strong>Patients with pre-eclampsia (n=11) and normotensive pregnant women (n=11) received de novo epidural anesthesia for cesarean delivery. We administered 21 mL of an epidural solution containing 2% lidocaine and 50 μg fentanyl into the lumbar epidural space in incremental doses. ONSD was measured at baseline, 3, 10, and 20 min after completing the epidural injection, after delivery, and at the end of surgery. Primary outcome was the change in ONSD from baseline to 3 min after epidural injection in patients with pre-eclampsia and normotensive pregnant women. Serial changes in the ONSD were analyzed using a linear mixed model.</p><p><strong>Results: </strong>At baseline and 3 min after epidural drug injection, ONSD was significantly larger in patients with pre-eclampsia than in normotensive mothers (5.7 vs 4.1 mm, p=0.001 and 5.4 vs 4.1 mm, p<0.001, respectively). However, there were no significant changes in ONSD at 3 min after injection from baseline in either group (p>0.999). Linear mixed model demonstrated that ONSD did not change after epidural anesthesia in either group (p=0.279 and p=0.347, respectively).</p><p><strong>Conclusions: </strong>Despite a higher baseline ONSD in pre-eclampsia, epidural anesthesia did not further increase ONSD. Our findings indicate that epidural anesthesia can be safely administered in patients with pre-eclampsia at risk of increased intracranial pressure, without other intracranial pathology.</p><p><strong>Trial registration number: </strong>NCT04095832.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"828-834"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An elusive truth: does the mechanism of action of the ESP block really matter for rib fractures?","authors":"Andreas Sotiriou, Amit Pawa","doi":"10.1136/rapm-2024-105827","DOIUrl":"10.1136/rapm-2024-105827","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"843-844"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141768090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruba Sajdeya, Masoud Rouhizadeh, Robert L Cook, Ronald L Ison, Chen Bai, Sebastian Jugl, Hanzhi Gao, Mamoun T Mardini, Osama Dasa, Kimia Zandbiglari, Farzana I Adiba, Almut G Winterstein, Catherine C Price, Thomas A Pearson, Christoph N Seubert, Patrick J Tighe
{"title":"Cannabis use and acute postoperative pain outcomes in older adults: a propensity matched retrospective cohort study.","authors":"Ruba Sajdeya, Masoud Rouhizadeh, Robert L Cook, Ronald L Ison, Chen Bai, Sebastian Jugl, Hanzhi Gao, Mamoun T Mardini, Osama Dasa, Kimia Zandbiglari, Farzana I Adiba, Almut G Winterstein, Catherine C Price, Thomas A Pearson, Christoph N Seubert, Patrick J Tighe","doi":"10.1136/rapm-2024-105633","DOIUrl":"10.1136/rapm-2024-105633","url":null,"abstract":"<p><strong>Introduction: </strong>Cannabis use is increasing among older adults, but its impact on postoperative pain outcomes remains unclear in this population. We examined the association between cannabis use and postoperative pain levels and opioid doses within 24 hours of surgery.</p><p><strong>Methods: </strong>We conducted a propensity score-matched retrospective cohort study using electronic health records data of 22 476 older surgical patients with at least 24-hour hospital stays at University of Florida Health between 2018 and 2020. Of the original cohort, 2577 patients were eligible for propensity-score matching (1:3 cannabis user: non-user). Cannabis use status was determined via natural language processing of clinical notes within 60 days of surgery and structured data. The primary outcomes were average Defense and Veterans Pain Rating Scale (DVPRS) score and total oral morphine equivalents (OME) within 24 hours of surgery.</p><p><strong>Results: </strong>504 patients were included (126 cannabis users and 378 non-users). The median (IQR) age was 69 (65-72) years; 295 (58.53%) were male, and 442 (87.70%) were non-Hispanic white. Baseline characteristics were well balanced. Cannabis users had significantly higher average DVPRS scores (median (IQR): 4.68 (2.71-5.96) vs 3.88 (2.33, 5.17); difference=0.80; 95% confidence limit (CL), 0.19 to 1.36; p=0.01) and total OME (median (IQR): 42.50 (15.00-60.00) mg vs 30.00 (7.50-60.00) mg; difference=12.5 mg; 95% CL, 3.80 mg to 21.20 mg; p=0.02) than non-users within 24 hours of surgery.</p><p><strong>Discussion: </strong>This study showed that cannabis use in older adults was associated with increased postoperative pain levels and opioid doses.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"771-778"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11683156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Acute reversal of respiratory distress after a preoperative single-shot interscalene nerve block.","authors":"Robert J Meulemans, Bastiaan M Gerritse","doi":"10.1136/rapm-2024-105728","DOIUrl":"10.1136/rapm-2024-105728","url":null,"abstract":"<p><strong>Background: </strong>Diaphragmatic paresis is a known complication of the interscalene block used for postoperative analgesia in shoulder surgery. A technique involving the injection of normal saline through the interscalene catheter to alleviate this condition has shown promise. This method, termed the \"washing-off\" technique, dilutes the local anesthetic around the phrenic nerve, mitigating respiratory symptoms.</p><p><strong>Case presentation: </strong>A 65-year-old male patient with multiple comorbidities (American Society of Anesthesiologists physical status classification 4) was scheduled for arteriovenous brachiocephalic fistula creation under regional anesthesia. Following an interscalene block with 32 mL of mepivacaine 1.5%, the patient experienced acute respiratory distress, with SpO<sub>2</sub> at 88% despite 6 L O<sub>2</sub> via nasal cannula. To avoid intubation, a 20 mL normal saline injection was administered through single-shot interscalene injection under ultrasound guidance. Within 5 min, respiratory distress markedly improved, allowing the patient to converse. Surgery proceeded without complications, maintaining SpO<sub>2</sub> at 99% with 6 L O<sub>2</sub>. Postoperatively, the patient remained stable, with SpO<sub>2</sub> at 98% on 2 L O<sub>2</sub>, and was discharged from the recovery room without additional oxygen requirements.</p><p><strong>Conclusions: </strong>The \"washing-off\" technique's mechanism may involve dilutional effects, pH changes or local sodium concentration alterations affecting the phrenic nerve. This case demonstrates its effectiveness in an acute setting, enabling surgery under regional anesthesia without intubation or any additional analgesia. The previously considered placebo effect appears unlikely here.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"839-840"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing the clarity and reproducibility of regional anesthesia techniques: a call for video integration in scientific publications.","authors":"Alessandro De Cassai, Burhan Dost, Serkan Tulgar","doi":"10.1136/rapm-2024-105871","DOIUrl":"10.1136/rapm-2024-105871","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"842-843"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Johana Klasova, Nasir Hussain, Ibrahim Umer, Ahmed Al-Hindawi, Mariam ElSaban, Simmy Lahori, Ryan S D'Souza
{"title":"Emotional and psychosocial function after dorsal column spinal cord stimulator implantation: a systematic review and meta-analysis.","authors":"Johana Klasova, Nasir Hussain, Ibrahim Umer, Ahmed Al-Hindawi, Mariam ElSaban, Simmy Lahori, Ryan S D'Souza","doi":"10.1136/rapm-2024-105523","DOIUrl":"10.1136/rapm-2024-105523","url":null,"abstract":"<p><strong>Background: </strong>The efficacy of spinal cord stimulation (SCS) in chronic pain studies is traditionally assessed by pain scores, which do not reflect the multidimensional nature of pain perception. Despite the evidence of SCS's influence on emotional functioning comprehensive assessments of its effect remain lacking.</p><p><strong>Objective: </strong>To assess changes in emotional and psychosocial functioning in patients who underwent SCS implantation for chronic pain.</p><p><strong>Evidence review: </strong>Ovid MEDLINE, EMBASE, PsychINFO, Cochrane CENTRAL and Scopus databases were searched for original peer-reviewed publications reporting emotional functioning after SCS. The primary outcomes were a pooled mean difference (MD) in anxiety, depression, global functioning, mental well-being and pain catastrophizing at 12 months. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) was used to determine the quality of evidence.</p><p><strong>Findings: </strong>Thirty-two studies were included in the primary analysis. Statistically significant improvements were observed in anxiety (MD -2.16; 95% CI -2.84 to -1.49; p<0.001), depression (MD -4.66; 95% CI -6.26 to -3.06; p<0.001), global functioning (MD 20.30; 95% CI 14.69 to 25.90; p<0.001), mental well-being (MD 4.95; 95% CI 3.60 to 6.31; p<0.001), and pain catastrophizing (MD -12.09; 95% CI -14.94 to -9.23; p<0.001). Subgroup analyses revealed differences in Global Assessment of Functioning and mental well-being based on study design and in depression based on waveform paradigm.</p><p><strong>Conclusion: </strong>The results highlight the statistically and clinically significant improvements in emotional and psychosocial outcomes in patients with chronic pain undergoing SCS therapy. However, these results need to be interpreted with caution due to the very low certainty of evidence per the GRADE criteria.</p><p><strong>Prospero registration: </strong>CRD42023446326.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"794-805"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141472690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Madeleine Luchsinger, Victor Varela, Sandeep Diwan, Alberto Prats-Galino, Xavier Sala-Blanch
{"title":"Erector spinae plane infiltration and anterior rami of spinal nerve: a cadaveric study.","authors":"Madeleine Luchsinger, Victor Varela, Sandeep Diwan, Alberto Prats-Galino, Xavier Sala-Blanch","doi":"10.1136/rapm-2024-105691","DOIUrl":"10.1136/rapm-2024-105691","url":null,"abstract":"<p><strong>Background: </strong>The erector spinae plane block (ESP block) is frequently employed for thoracic, abdominal, and spinal surgeries, yet its precise mechanism of action remains a subject of debate. While initially postulated to influence both ventral and dorsal rami of the spinal nerve, recent studies indicate a predominant impact on the dorsal rami with limited involvement of the ventral rami. To elucidate this mechanism, we conducted an observational study to assess the distribution of ESP infiltration to the ventral rami.</p><p><strong>Methods: </strong>We performed 20 ESP infiltrations bilaterally in 10 unembalmed cadavers, targering the T9 transverse process level. A volume of 20 mL of ropivacaine 0.2% and methylene blue 0.01% was used. Dissection was carried out to assess dye distribution, with a focus on involvement of the ventral and dorsal rami, as well as lateral and longitudinal spread within the spinal muscular plane.</p><p><strong>Results: </strong>No evidence of dye staining was observed in the ventral rami in any of the cadavers; however, the dorsal rami consistently displayed staining. The dye exhibited extensive longitudinal diffusion across the paravertebral musculature, spanning a median of 10 vertebral spaces (T5-L2). The range extended from 3 to 18 spaces, with an IQR of 11 levels (T4-L2), predominantly affecting the longissimus and iliocostalis muscles.</p><p><strong>Conclusions: </strong>The infiltration of injectate into the ESP does not contact the ventral rami of segmental spinal nerves. The inference that an in vivo ESP block is a paravertebral \"by-proxy\" is, therefore, unlikely.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":"815-819"},"PeriodicalIF":3.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}