Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Department of Surgery, Division of Hepatobiliary and Pancreatic Surgery, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Korea.
Br J Surg. 2024 Nov 27;111(12). doi: 10.1093/bjs/znae296.
Thoracic epidural analgesia (TEA), once the standard for pain management in major abdominal operations, is associated with postoperative complications, making preperitoneal continuous wound infiltration (CWI) a promising alternative. This study aimed to compare the effectiveness of CWI and TEA in managing postoperative pain after open pancreatoduodenectomy.
In a single-centre, randomized, open-label non-inferiority trial, adult patients undergoing elective open pancreatoduodenectomy were assigned to either CWI or TEA for pain management. The primary outcomes were mean pain scores at rest on the first 3 postoperative days (PODs), using an 11-point numeric rating scale, with a non-inferiority margin of 1 point or less. Secondary outcomes included pain scores at rest and during coughing on PODs 1, 2, and 3; total opioid consumption; incidence of postoperative complications; quality of postoperative recovery; and duration of hospital stay.
Among the 134 patients analysed (CWI 70, TEA 64), CWI was non-inferior to TEA in terms of mean pain scores at rest (mean difference -0.13, 95% c.i. -0.72 to 0.47). Additionally, CWI demonstrated superior pain relief at rest and higher-quality recovery scores on POD 3. Compared with CWI, TEA was associated with significantly decreased total opioid consumption and shortened time to the first passage of flatus, but a higher incidence of postoperative hypotension. No other outcome measures showed significant differences between the two groups.
CWI was non-inferior to TEA during the early postoperative period, and has emerged as a favourable alternative to TEA, offering better pain relief and enhanced recovery on POD 3. Registration number: NCT04375826 (http://www.clinicaltrials.gov).
胸段硬膜外镇痛（TEA）曾是腹部大手术疼痛管理的标准方法，但与术后并发症相关，使腹膜前连续切口浸润（CWI）成为一种有前途的替代方法。本研究旨在比较 CWI 和 TEA 在管理开腹胰十二指肠切除术后疼痛方面的效果。
在一项单中心、随机、开放标签、非劣效性试验中，接受择期开腹胰十二指肠切除术的成年患者被分配到 CWI 或 TEA 组进行疼痛管理。主要结局是术后第 1 至 3 天（POD）静息时的平均疼痛评分，采用 11 分数字评分量表，非劣效性边界为 1 分或以下。次要结局包括 POD1、2 和 3 时静息和咳嗽时的疼痛评分；总阿片类药物消耗量；术后并发症发生率；术后恢复质量；以及住院时间。
在分析的 134 例患者中（CWI 组 70 例，TEA 组 64 例），CWI 在静息时平均疼痛评分方面与 TEA 相当（平均差异 -0.13，95%置信区间 -0.72 至 0.47）。此外，CWI 在 POD3 时表现出更好的静息时疼痛缓解和更高的恢复质量评分。与 CWI 相比，TEA 与总阿片类药物消耗量显著减少和首次排气时间缩短相关，但术后低血压发生率较高。两组之间的其他结局指标没有显示出显著差异。
在术后早期，CWI 与 TEA 相当，并且已成为 TEA 的有利替代方法，在 POD3 时提供更好的疼痛缓解和增强的恢复。注册号：NCT04375826（http://www.clinicaltrials.gov）。
