Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada
Department of Anesthesia, The Ottawa Hospital, Ottawa, Ontario, Canada.
BMJ Open. 2020 Jun 28;10(6):e025818. doi: 10.1136/bmjopen-2018-025818.
Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.
150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6 months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60 mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines.
Demographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6 min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication.
Ethics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal.
Pre-results NCT03367728.
评估腹腔镜引导下经腹横肌平面（TAP）和腹直肌鞘（RS）阻滞在减少接受腹腔镜减重手术患者的镇痛药物消耗的同时改善其功能结局的疗效。
在 6 个月内，从一个减重卓越中心，我们将招募 150 名患有肥胖症且接受择期腹腔镜 Roux-en-Y 胃旁路术的肥胖患者参加这项双盲、安慰剂对照随机对照试验。患者将以 1:1 的比例电子随机分配到干预组或安慰剂组。干预组将接受总共 60ml 0.25%罗哌卡因，分为四部分注射：腹腔镜可视化下 TAP 和 RS 阻滞各两部分。安慰剂组将以同样的方式接受生理盐水。将遵循标准化的手术和麻醉方案，并严格遵守减重手术后的加速康复指南。
将从参加研究的 150 名患者中收集人口统计学信息和相关病史。我们的主要疗效终点是术后累积阿片类药物使用量。次要结果是呼气峰值流量、术后疼痛评分和 6 分钟步行试验。使用经过验证的问卷（QoR-40）评估恢复质量（QoR）。将通过混合模型方法进行统计分析，以评估两组之间和组内的差异。将通过重复测量分析方法进行分析，并通过发表的文章报告结果。
我们已通过机构研究伦理委员会（渥太华健康科学网络研究伦理委员会）获得伦理批准（20170749-01H），无论结果如何，研究结果都将在提交给医学/外科杂志的手稿中报告。
预结果 NCT03367728。
