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术中使用美沙酮对接受腹腔镜子宫切除术患者的临床有效性和安全性:一项随机、盲法临床试验

Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial.

作者信息

Friesgaard Kristian D, Brix Lone D, Kristensen Christina B, Rian Omar, Nikolajsen Lone

机构信息

Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital, Horsens, Denmark.

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.

出版信息

BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep.

DOI:10.1016/j.bjao.2023.100219
PMID:37638083
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10457492/
Abstract

BACKGROUND

Laparoscopic hysterectomy is often carried out as day-stay surgery. Minimising postoperative pain is therefore of utmost importance to ensure timely discharge from hospital. Methadone has several desirable pharmacological features, including a long elimination half-life. Therefore, a single intraoperative dose could provide long-lasting pain relief.

METHODS

Patients scheduled to undergo laparoscopic hysterectomy were randomly allocated to receive methadone (0.2 mg kg) or morphine (0.2 mg kg) intraoperatively, 60 min before tracheal extubation. Primary outcomes were opioid consumption (oral morphine equivalents in milligrams) at 6 and 24 h. Secondary outcomes included pain intensity at rest and during coughing, patient satisfaction, postoperative nausea and vomiting, and adverse events up to 72 h after completion of surgery.

RESULTS

The postoperative median opioid consumption was reduced in the methadone group compared with the morphine group at 6 h (35.5 [0-61] mg 48 [31-74.5] mg; =0.01) and 24 h (42 [10-67] mg 54.5 [31-83] mg; =0.03). On arrival at the PACU, pain at rest was significantly lower in patients receiving methadone (numeric rating scale: 3 [2-5] 5 [3-6]), whereas pain scores at rest and coughing were not significantly different throughout the rest of the observation period. No differences in other secondary outcomes were found.

CONCLUSIONS

In this randomised, blinded, controlled trial, opioid consumption was reduced during the first 24 postoperative hours in patients receiving methadone without causing an increase in adverse events. The difference observed might be considered as small and of limited clinical relevance.

CLINICAL TRIAL REGISTRATION

NCT03908060; EudraCT no. 2018-004351-20.

摘要

背景

腹腔镜子宫切除术通常作为日间手术进行。因此,将术后疼痛降至最低对于确保及时出院至关重要。美沙酮具有多种理想的药理学特性,包括较长的消除半衰期。因此,术中单次给药即可提供持久的疼痛缓解。

方法

计划接受腹腔镜子宫切除术的患者被随机分配在气管拔管前60分钟术中接受美沙酮(0.2毫克/千克)或吗啡(0.2毫克/千克)。主要结局指标为术后6小时和24小时的阿片类药物消耗量(以毫克为单位的口服吗啡当量)。次要结局指标包括静息和咳嗽时的疼痛强度、患者满意度、术后恶心和呕吐以及术后72小时内的不良事件。

结果

与吗啡组相比,美沙酮组术后6小时(35.5[0 - 61]毫克对48[31 - 74.5]毫克;P = 0.01)和24小时(42[10 - 67]毫克对54.5[31 - 83]毫克;P = 0.03)的阿片类药物消耗量中位数降低。到达麻醉后恢复室时,接受美沙酮的患者静息时疼痛明显较轻(数字评分量表:3[2 - 5]对5[3 - 6]),而在其余观察期内静息和咳嗽时的疼痛评分无显著差异。未发现其他次要结局指标存在差异。

结论

在这项随机、双盲、对照试验中,接受美沙酮的患者术后24小时内阿片类药物消耗量减少,且未导致不良事件增加。观察到的差异可能被认为较小且临床相关性有限。

临床试验注册

NCT03908060;欧盟临床试验编号2018 - 004351 - 20。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b544/10457492/7b1f3ec1ee0e/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b544/10457492/34224ee1a4b9/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b544/10457492/7b1f3ec1ee0e/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b544/10457492/34224ee1a4b9/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b544/10457492/7b1f3ec1ee0e/gr2.jpg

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本文引用的文献

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Facts Views Vis Obgyn. 2019 Jun;11(2):103-110.
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Intraoperative Methadone Reduces Pain and Opioid Consumption in Acute Postoperative Pain: A Systematic Review and Meta-analysis.术中使用美沙酮减轻急性术后疼痛和阿片类药物消耗:系统评价和荟萃分析。
Anesth Analg. 2019 Dec;129(6):1723-1732. doi: 10.1213/ANE.0000000000004404.
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Intraoperative methadone administration and postoperative pain control: a systematic review and meta-analysis.
术中给予美沙酮和术后疼痛控制:系统评价和荟萃分析。
Pain. 2020 Feb;161(2):237-243. doi: 10.1097/j.pain.0000000000001717.
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Intraoperative methadone for postoperative pain after laparoscopic hysterectomy: Protocol for a randomised, double-blind trial.腹腔镜子宫切除术后术中使用美沙酮缓解术后疼痛:一项随机、双盲试验的方案。
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A preoperative single dose of methadone for moderate-to-severely painful surgery reduces postoperative morphine consumption.术前给予单剂量美沙酮可减少中重度疼痛手术患者术后吗啡的用量。
Minerva Anestesiol. 2019 Oct;85(10):1053-1061. doi: 10.23736/S0375-9393.19.13136-7. Epub 2019 May 14.
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