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比较阿片类药物节俭的多模式镇痛与基于吗啡的患者自控镇痛在结直肠癌微创手术中的镇痛效果。

Comparison of the Analgesic Efficacy of Opioid-Sparing Multimodal Analgesia and Morphine-Based Patient-Controlled Analgesia in Minimally Invasive Surgery for Colorectal Cancer.

机构信息

Department of Anesthesiology and Pain Medicine, Kyungpook National University Chilgok Hospital, Daegu, Korea.

School of Medicine, Kyungpook National University, Daegu, Korea.

出版信息

World J Surg. 2022 Jul;46(7):1788-1795. doi: 10.1007/s00268-022-06473-5. Epub 2022 May 8.

Abstract

BACKGROUND

A multimodal analgesia (MMA) protocol has shown the effect of postoperative pain control and reduced the postoperative opioid consumption. However, it was questionable whether MMA could replace opioid-based patient-controlled analgesia (PCA) for postoperative pain control. Therefore, this study aimed to investigate whether an MMA protocol is non-inferior to opioid-based PCA for pain management after a minimally invasive colorectal cancer surgery.

METHODS

A randomized, open-label, non-inferiority clinical trial was conducted on patients undergoing laparoscopic or robotic resection of colorectal cancer. The patients were randomly assigned to either the PCA or MMA group. The MMA protocol included pregabalin, tramadol, wound infiltration, and transversus abdominis plane block. The primary outcome was the numeric rating scale (NRS) score for pain at rest 24 h postoperatively.

RESULTS

Ninety-seven patients were included in the intention-to-treat analysis. The mean difference in NRS score at rest at 24 h was 0.25 (95% confidence interval, - 0.61 to 1.11). This result demonstrated the non-inferiority of MMA to PCA in our non-inferiority margin (- 1). Compared with the PCA group, the median remifentanil dose (996 vs. 654 μg; p < 0.001) and time in the post-anesthesia care unit (35 vs. 25 min; p < 0.001) were significantly less in the MMA group.

CONCLUSIONS

Our MMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA based on patient-reported pain intensity, with no significant increase in adverse events. These results will help construct a strategy to reduce conventional opioid prescriptions for pain management after a minimally invasive colorectal cancer surgery. Trial Registration Number Trial Registration Clinical Research Information Service Identifier: KCT0002593.

摘要

背景

多模式镇痛(MMA)方案已显示出控制术后疼痛和减少术后阿片类药物消耗的效果。然而,MMA 是否可以替代基于阿片类药物的患者自控镇痛(PCA)来控制术后疼痛仍存在疑问。因此,本研究旨在探讨 MMA 方案是否在微创结直肠癌手术后的疼痛管理中不劣于基于阿片类药物的 PCA。

方法

对接受腹腔镜或机器人结直肠癌切除术的患者进行了一项随机、开放标签、非劣效性临床试验。患者被随机分配到 PCA 组或 MMA 组。MMA 方案包括普瑞巴林、曲马多、伤口浸润和腹横肌平面阻滞。主要结局是术后 24 小时静息时的数字评分量表(NRS)疼痛评分。

结果

97 例患者纳入意向治疗分析。24 小时静息时 NRS 评分的平均差异为 0.25(95%置信区间,-0.61 至 1.11)。这一结果表明,MMA 在我们设定的非劣效性边界(-1)内不劣于 PCA。与 PCA 组相比,MMA 组的瑞芬太尼剂量中位数(996 对 654μg;p<0.001)和麻醉后护理单元时间(35 对 25 分钟;p<0.001)显著减少。

结论

我们的 MMA 方案成功控制了术后疼痛,在患者报告的疼痛强度方面不劣于基于吗啡的 PCA,且不良事件无显著增加。这些结果将有助于制定一种策略,以减少微创结直肠癌手术后常规阿片类药物的处方。试验注册号 临床试验注册信息服务标识符:KCT0002593。

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