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腹腔镜与开腹胃癌根治术术后疼痛和阿片类药物消耗的比较:一项多中心随机临床试验(LOGICA 试验)的二次分析。

Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial).

机构信息

Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands.

Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.

出版信息

J Gastrointest Surg. 2023 Oct;27(10):2057-2067. doi: 10.1007/s11605-023-05728-3. Epub 2023 Jul 18.

Abstract

BACKGROUND

Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail.

METHODS

This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1-5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0-10) at POD 1-10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia.

RESULTS

Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1-3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p < 0.001). After correcting for epidural analgesia, these differences remained significant at POD 1-2 (47 mg OME, p = 0.002 and 69 mg OME, p < 0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids (p = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs, < 2 at discharge, and did not relevantly differ between treatment arms.

CONCLUSION

In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids.

TRIAL REGISTRATION

NCT02248519.

摘要

背景

与开腹手术相比,腹腔镜胃切除术可减轻疼痛和阿片类药物的消耗。然而,由于这些结果仅在少数随机试验中报告且细节有限,因此很难判断这种减少的临床相关性。

方法

本项多中心随机试验的二次分析比较了腹腔镜与开腹胃切除术治疗可切除的胃腺癌(cT1-4aN0-3bM0)。术后疼痛通过术后第 1-5 天口服吗啡当量(OME,mg/天)、世界卫生组织镇痛步骤和术后第 1-10 天和出院时的数字评分量表(NRS,0-10)进行分析。进行了回归和混合模型分析,同时和不校正硬膜外镇痛。

结果

在 2015 年至 2018 年间,腹腔镜组 115 例患者和开腹组 110 例患者接受了手术。腹腔镜组中有 16 例(14%)患者和开腹组中有 73 例(66%)患者接受了硬膜外镇痛。在术后第 1-3 天,与开腹组相比,腹腔镜组的 OME 分别低 131、118 和 53mg(均 p<0.001)。在校正硬膜外镇痛后,这些差异在术后第 1-2 天仍有统计学意义(47mg OME,p=0.002 和 69mg OME,p<0.001)。出院时,腹腔镜组有 27%的患者和开腹组有 43%的患者使用口服阿片类药物(p=0.006)。所有 POD 的最高日疼痛评分均在 2-4 之间,出院时评分<2,且两组之间无明显差异。

结论

在这项多中心随机试验中,腹腔镜和开腹胃切除术的术后疼痛相似。腹腔镜胃切除术后,通常无需硬膜外镇痛即可实现这一目标,且阿片类药物的使用也更少。

试验注册

NCT02248519。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fd3/10579125/e834207822f1/11605_2023_5728_Fig1_HTML.jpg

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