Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.
Division of General and Hepatobiliary Surgery, University Hospital "G.B. Rossi", Piazzale "L. Scuro" 10, 37134, Verona, Italy.
Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.
Transversus abdominis plane (TAP) block is considered a reliable locoregional technique for pain control after laparoscopic colorectal surgery. However, no clear benefit of TAP block over wound infiltration has been demonstrated by the current literature. This multicenter randomized clinical trial tested the non-inferiority of wound infiltration (WI) compared to WI plus laparoscopic-assisted TAP block (L-TAP).
All patients with colorectal cancer and diverticular disease scheduled for laparoscopic resection at the Division of General and Hepatobiliary Surgery, University of Verona Hospital Trust, Verona, Italy and at the Colorectal Cancer Center, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea, between April 2018 and March 2019 were considered for the trial. Patients were randomly allocated to either the WI group or the WI plus L-TAP group in a 1:1 allocation ratio. In total, 108 patients entered the study and 102 patients were analyzed; 50 patients received WI plus L-TAP and 52 patients received WI. The primary end point was the efficacy in pain control at 6 h measured according to Numeric Rating Scale (NRS). Secondary aims evaluated pain control at 12, 24, 48 and 72 h and other short-term results related to pain management.
Estimation of pain intensity at 6 h was comparable between the two groups (p = 0.16) with a mean (95% CI) difference in pain scores of 0.94 (- 0.13 to 2.02). No differences in pain scores were observed at other interval times or considering analgesic consumption, return of bowel function, postoperative complications and length of hospital stay.
This study suggests that adding TAP block to WI does not affect pain control, amount of analgesics and other short-term outcomes.
NCT03376048 ( https://www.clinicaltrials.gov ).
腹横肌平面(TAP)阻滞被认为是腹腔镜结直肠手术后控制疼痛的一种可靠的局部区域技术。然而,目前的文献并没有证明 TAP 阻滞比伤口浸润更有优势。这项多中心随机临床试验测试了伤口浸润(WI)与 WI 加腹腔镜辅助 TAP 阻滞(L-TAP)相比的非劣效性。
所有在意大利维罗纳大学医院信托公司普外科和肝胆外科分部以及韩国大邱庆北国立大学医疗中心大肠癌中心接受腹腔镜切除术的结直肠癌和憩室病患者都符合该试验条件。患者按照 1:1 的比例随机分配到 WI 组或 WI 加 L-TAP 组。共有 108 例患者进入研究,102 例患者进行了分析;50 例患者接受了 WI 加 L-TAP,52 例患者接受了 WI。主要终点是根据数字评分量表(NRS)在 6 小时时评估的疼痛控制效果。次要目的评估了 12、24、48 和 72 小时时的疼痛控制情况以及与疼痛管理相关的其他短期结果。
两组患者在 6 小时时的疼痛强度估计值相似(p=0.16),疼痛评分的平均(95%CI)差值为 0.94(-0.13 至 2.02)。在其他间隔时间或考虑镇痛药物的使用、肠道功能恢复、术后并发症和住院时间方面,疼痛评分均无差异。
本研究表明,在 WI 中加入 TAP 阻滞不会影响疼痛控制、镇痛药的使用量和其他短期结果。
NCT03376048(https://www.clinicaltrials.gov)。