Department of Anaesthesiology and Critical Care, Galway University Hospital, Galway, Ireland.
National University of Ireland Galway, Galway, Ireland.
Trials. 2024 Sep 28;25(1):634. doi: 10.1186/s13063-024-08472-4.
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.
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.
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.
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.
肥胖是一个迅速增长的全球健康问题。饮食、行为改变和医学治疗的长期效果有限，导致减重手术的应用日益增加。腹腔镜袖状胃切除术永久性地缩小胃的大小，已被证明能显著减轻体重，并改善甚至消除肥胖相关的合并症，如糖尿病、阻塞性睡眠呼吸暂停和高血压。不幸的是，这种手术也会导致明显的术后疼痛，再加上肥胖患者围手术期阿片类药物管理的危险，会导致康复质量显著下降。围手术期肥胖患者广泛推荐使用阿片类药物节约型镇痛，但针对这种手术的最佳区域镇痛方法的研究仍很缺乏，迄今为止尚无比较不同区域镇痛技术的试验。本研究方案描述了一项旨在回答这一问题的随机临床试验，比较接受竖脊肌平面阻滞的腹腔镜袖状胃切除术患者与接受胸锁乳突肌前缘平面阻滞加肋缘下 TAP 阻滞的患者的康复质量。
我们在爱尔兰的一家三级医院提出了一项前瞻性、随机、盲法（研究者）临床试验。将 70 例接受腹腔镜袖状胃切除术的患者随机分为两组：A 组接受双侧竖脊肌阻滞；B 组接受左侧胸锁乳突肌前缘平面阻滞加肋缘下 TAP 阻滞。两组均接受相同剂量的相同局部麻醉药，且护理中的唯一区别是不同的区域技术。主要结局是术后 24 小时的 QoR-15 评分，这是一种评估患者整体术后恢复的国际验证工具。
区域镇痛应该是围手术期阿片类药物节约型镇痛的主要方法。这在肥胖患者中尤为重要，他们特别容易受到围手术期阿片类药物管理并发症的影响。据我们所知，这项试验将是第一个比较两种不同的区域镇痛技术在接受腹腔镜袖状胃切除术的肥胖患者中的疗效的试验。
该试验于 2023 年 3 月 5 日在 clinicaltrials.gov 上预先注册，注册号为 NCT05839704。世界卫生组织试验注册数据集中的所有项目均已包含在内。
