A comparison of efficacy of erector spinae plane block versus serratus anterior plane block plus subcostal transversus abdominus plane block for bariatric laparoscopic sleeve gastrectomy surgery: study protocol for a randomised clinical trial.

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Abstract Background Obesity is a rapidly growing global health concern. Limited long-term success of diet, behavioural modification and medical therapy have led to the increased performance of bariatric surgery. Laparoscopic sleeve gastrectomy, which permanently reduces the size of the stomach, has been shown to cause considerable weight loss, as well as improving or even eliminating obesity related medical comorbidities such as diabetes, obstructive sleep apnoea and hypertension. Unfortunately, this surgery can also result in significant postoperative pain which, when combined with the dangers of perioperative opioid administration for bariatric patients, can lead to a significantly reduced quality of recovery. Opioid-sparing analgesia has been widely recommended for perioperative bariatric patients but research into the optimum regional analgesia approach for this surgery is lacking, with no trials to date comparing different regional analgesic techniques. This study protocol describes a randomised clinical trial aimed at answering this question, comparing the quality of recovery after laparoscopic sleeve gastrectomy for patients who receive erector spinae plane block, versus those who receive serratus anterior plane block plus subcostal TAP block. Methods We propose a prospective, randomised, blinded (investigator) clinical trial in a tertiary hospital in Ireland. 70 patients presenting for laparoscopic sleeve gastrectomy will be randomised to two study groups – group A will receive bilateral erector spinae blockade, group B will receive left sided serratus anterior plane block plus subcostal TAP blocks. Both groups will receive the same dose of the same local anaesthetic and the different regional technique performed will be the only difference in their care. The primary outcome will be QoR-15 scores at 24 hours postoperatively, a validated international tool for assessing a patient’s overall postoperative recovery. Discussion Regional analgesia should be a mainstay of perioperative opioid-sparing analgesia where possible. This is especially important in the bariatric cohort who are particularly susceptible to the complications of perioperative opioid administration. To the best of our knowledge, this trial will be the first to compare efficacy of two different regional analgesia techniques for bariatric patients undergoing laparoscopic sleeve gastrectomy surgery. Trial Registration This trial was pre-registered on clinicaltrials.gov, reference number NCT05839704, on March 5th 2023. All items from the World Health Organisation Trial Registration Data Set have been included.
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A comparison of efficacy of erector spinae plane block versus serratus anterior plane block plus subcostal transversus abdominus plane block for bariatric laparoscopic sleeve gastrectomy surgery: study protocol for a randomised clinical trial. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A comparison of efficacy of erector spinae plane block versus serratus anterior plane block plus subcostal transversus abdominus plane block for bariatric laparoscopic sleeve gastrectomy surgery: study protocol for a randomised clinical trial. Patrick N Wiseman, Michaela Van der Walt, Michael O'Riordan, Kieran Brosnan, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4618368/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Sep, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Obesity is a rapidly growing global health concern. Limited long-term success of diet, behavioural modification and medical therapy have led to the increased performance of bariatric surgery. Laparoscopic sleeve gastrectomy, which permanently reduces the size of the stomach, has been shown to cause considerable weight loss, as well as improving or even eliminating obesity related medical comorbidities such as diabetes, obstructive sleep apnoea and hypertension. Unfortunately, this surgery can also result in significant postoperative pain which, when combined with the dangers of perioperative opioid administration for bariatric patients, can lead to a significantly reduced quality of recovery. Opioid-sparing analgesia has been widely recommended for perioperative bariatric patients but research into the optimum regional analgesia approach for this surgery is lacking, with no trials to date comparing different regional analgesic techniques. This study protocol describes a randomised clinical trial aimed at answering this question, comparing the quality of recovery after laparoscopic sleeve gastrectomy for patients who receive erector spinae plane block, versus those who receive serratus anterior plane block plus subcostal TAP block. Methods We propose a prospective, randomised, blinded (investigator) clinical trial in a tertiary hospital in Ireland. 70 patients presenting for laparoscopic sleeve gastrectomy will be randomised to two study groups – group A will receive bilateral erector spinae blockade, group B will receive left sided serratus anterior plane block plus subcostal TAP blocks. Both groups will receive the same dose of the same local anaesthetic and the different regional technique performed will be the only difference in their care. The primary outcome will be QoR-15 scores at 24 hours postoperatively, a validated international tool for assessing a patient’s overall postoperative recovery. Discussion Regional analgesia should be a mainstay of perioperative opioid-sparing analgesia where possible. This is especially important in the bariatric cohort who are particularly susceptible to the complications of perioperative opioid administration. To the best of our knowledge, this trial will be the first to compare efficacy of two different regional analgesia techniques for bariatric patients undergoing laparoscopic sleeve gastrectomy surgery. Trial Registration This trial was pre-registered on clinicaltrials.gov, reference number NCT05839704, on March 5th 2023. All items from the World Health Organisation Trial Registration Data Set have been included. Bariatric surgery Laparoscopic sleeve gastrectomy Opioid-sparing analgesia Erector spinae plane block Serratus anterior plane block Subcostal TAP block Quality of recovery Full Text Supplementary Files Appendix1PatientConsentForm.doc Appendix2StudyReportForm.docx TrialProtocolSPIRITChecklist.docx Cite Share Download PDF Status: Published Journal Publication published 28 Sep, 2024 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 20 Aug, 2024 Reviewers agreed at journal 30 Jul, 2024 Reviewers invited by journal 11 Jul, 2024 Editor assigned by journal 09 Jul, 2024 First submitted to journal 21 Jun, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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