Patient preference for intraoperative opioid use and early recovery after noncardiac surgery: protocol for a randomised factorial design trial of opioid-free versus opioid-based anaesthesia (the PERFECT trial)

Yann Gricourt , Nancy M. Boulos , Amelie Delaporte , Brenton Alexander , Stephane Besada , Ryan Bakhit , Aline Toukhtarian , Ido Neuman , Daniel Pearce , Meziar M. Nourian , Arthur Chebishian , Amy Zhou , Janice Boktor , Dylan Mayanja , Tristan Grogan , David Boldt , Maxime Cannesson , Patrice Forget , Alexandre Joosten
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引用次数: 0

Abstract

Introduction

Although opioids are commonly used to relieve pain associated with surgery, they are not consequence free. Moreover, the USA and many western countries are currently experiencing a significant health crisis because of opioid addiction and its related overdose potential. There have been no studies that have evaluated patient preference regarding opioid use and its potential impact on the quality of recovery. The aim of this study is to compare the effect of patient preference on intraoperative opioid use on early postoperative quality of recovery after moderate risk laparoscopic/robotic abdominal surgery.

Methods

This trial is an interventional, pragmatic, partially randomised factorial trial. Adults (N=240) scheduled for moderate-risk abdominal surgery under laparoscopic/robotic assistance (colorectal, urologic, and gynaecologic) will be allocated into four groups, according to their preference (choice of opioid-free vs opioid-based anaesthesia vs no choice and, if no choice, then the patient is randomised to opioid-based vs opioid-free anaesthesia). Anaesthesia providers and patients who choose their anaesthesia type will be unblinded of the allocation group. The primary endpoint will be the Quality of Recovery-15 score at postoperative day 1. Secondary endpoints will include patient satisfaction, postoperative nausea and vomiting, intraoperative bradycardia, postoperative opioid consumption, postoperative hypoxemia, and health-related quality of life using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L).

Conclusions

This trial will provide evidence on whether patient preference on intraoperative opioid use can improve patient quality of recovery after moderate-risk abdominal surgery.

Clinical trial registration

NCT06855641.

Protocol version number and date

2.0, 24 February 2025.
患者对术中阿片类药物使用的偏好和非心脏手术后的早期恢复:无阿片类药物与基于阿片类药物的麻醉的随机因子设计试验方案(PERFECT试验)
虽然阿片类药物通常用于缓解手术相关疼痛,但它们并不是没有后果的。此外,美国和许多西方国家目前正经历着严重的健康危机,因为阿片类药物成瘾及其相关的过量可能性。目前还没有研究评估患者对阿片类药物使用的偏好及其对康复质量的潜在影响。本研究的目的是比较患者对术中阿片类药物使用的偏好对中等风险腹腔镜/机器人腹部手术术后早期恢复质量的影响。方法本试验为干预性、实用性、部分随机因子试验。计划在腹腔镜/机器人辅助下进行中等风险腹部手术的成年人(N=240)(结直肠、泌尿和妇科)将根据他们的偏好分为四组(选择无阿片类药物麻醉vs无阿片类药物麻醉vs无阿片类药物麻醉,如果没有选择,则患者随机分配到阿片类药物麻醉vs无阿片类药物麻醉)。麻醉提供者和选择麻醉类型的患者将被解除分配组的盲法。主要终点将是术后第1天的恢复质量-15评分。次要终点将包括患者满意度、术后恶心和呕吐、术中心动过缓、术后阿片类药物消耗、术后低氧血症和与健康相关的生活质量(使用EuroQoL 5-Dimension 5-Level (EQ-5D-5L))。结论本试验将提供证据,证明患者对术中阿片类药物的使用偏好是否能提高中等风险腹部手术后患者的康复质量。临床试验注册号nct06855641。协议版本号和日期2.0,2025年2月24日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BJA open
BJA open Anesthesiology and Pain Medicine
CiteScore
0.60
自引率
0.00%
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0
审稿时长
83 days
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