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. Seventy 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 h 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, registration number NCT05839704, on March 5, 2023. All items from the World Health Organisation Trial Registration Data Set have been included.