Department of Anaesthesiology, Regional Hospital Centre Metz-Thionville, Metz Cedex 03, France.
Faculty of Medicine, Université de Lorraine-Site de Nancy, Vandoeuvre lès Nancy, France.
BMJ Open. 2023 May 23;13(5):e069736. doi: 10.1136/bmjopen-2022-069736.
INTRODUCTION: Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy. METHODS AND ANALYSIS: This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1-4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events. ETHICS AND DISSEMINATION: The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications. TRIAL REGISTRATION NUMBER: NCT04985695.
简介:术后加速康复(ERAS)方案通过预防术后疼痛、促进早期喂养和活动,提高了患者的舒适度,并显著降低了术后死亡率和医疗费用、缩短了住院时间。多模式镇痛是其中的一个关键环节,它可以预防术后疼痛,并有助于早期喂养和活动。胸段硬膜外镇痛(TEA)一直是前腹壁手术局部麻醉的金标准。然而,更新的壁层阻滞技术,如腹直肌鞘阻滞(RSB),可能是更好的选择,因为它们的侵入性更小,并且可能具有同等的镇痛效果,副作用更少。由于证据基础仍然有限,因此设计了由 REctus sheat CATHeter 增强的康复质量(QoR-RECT-CATH)随机对照试验(RCT),以评估在剖腹手术后,RSB 是否比 TEA 更能促进康复。
方法和分析:这项开放标签、平行臂、1:1 分配的 RCT 将在法国一家地区性医院进行,该医院在 ERAS 计划内为所有剖腹手术提供无阿片类药物麻醉。110 例计划接受中线剖腹手术的患者将被纳入研究,以评估 RSB 在术后康复质量方面是否优于 TEA。纳入标准为年龄≥18 岁、计划接受剖腹手术、美国麻醉医师协会(ASA)评分 1-4 级且无布比卡因/TEA 禁忌证的患者。TEA 组患者在手术前将接受硬膜外导管,而 RSB 组患者在手术后将接受腹直肌鞘导管。所有其他术前/术中/术后操作都将完全相同,包括根据我们的标准护理提供多模式术后镇痛。主要目标是术后第 2 天(POD)与基线相比,总 QoR-15F 评分的变化。QoR-15F 是一种患者报告的结局测量工具,常用于测量 ERAS 结局。15 项次要目标包括术后疼痛评分、阿片类药物消耗、功能恢复测量和不良事件。
伦理和传播:法国伦理委员会(南西南和海外伦理委员会)已批准该研究。在获得研究者提供的信息后,受试者将在书面同意后被招募。该研究的结果将通过同行评议的出版物公开,如果可能的话,还将通过会议出版物公开。
试验注册号:NCT04985695。
J Anesth Analg Crit Care. 2022-2-5
Eur J Anaesthesiol. 2021-7-1