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)

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 (N1/4240) 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.