Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery (PERFECT)

Patient Preference for Intraoperative Opioid Use and Early Recovery Following Non-Cardiac Surgery: Protocol for a Randomized Factorial Design Trial of Opioid-Free vs Opioid-Based Anesthesia (PERFECT TRIAL)

Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. 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 following moderate risk laparoscopic/robotic abdominal surgery.

Study Overview

• Status: Completed
• Conditions: Outcome Assessment; Opioid Free Anesthesia; Opioid Analgesia; Quality of Recovery (QoR-15)
• Intervention / Treatment: Procedure: Opioid based Anesthesia; Procedure: opioid free anesthesia

Detailed Description

Although opioid analgesic drugs are commonly used to relieve pain associated with surgery, they are not consequence free. Respiratory depression, postoperative nausea and vomiting (PONV), impaired gastrointestinal function, urinary retention are frequent concerns associated with their use. Moreover, the United States and many western countries are currently experiencing a significant health problem with opioid addiction and deaths due to overdose. Some opioid addiction pathways can trace their origin back to when a patient was first admitted to a hospital and received opioids in the setting of acute pain or surgery. As a result of this, there is likely a potential iatrogenic component to the current opioid abuse epidemic. Questioning the role of opioids is part of enhanced recovery after surgery programs, and good practice to reduce the risk of developing addiction and other side effects. Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. 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 following moderate risk laparoscopic/robotic abdominal surgery.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Ronald Reagan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years.
• Undergoing elective intermediate risk surgery under general anesthesia (robotic or laparoscopic assisted urological, gynecological or abdominal surgery).
• American Society Anesthesiologists physical status classification system grades of I-IV.
• English speaking.
• Informed consent signed.

Exclusion Criteria:

• Diagnosis of chronic pain
• Preoperative prescribed opioids
• Pregnancy or lactation.
• History of mental disorders.
• Contraindications to study drug (lidocaine, magnesium, dexmedetomidine, ketamine)
• Patient is participating in another interventional trial
• Patient is under judicial protection or is an adult under guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient choose his analgesia type; The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)	Procedure: Opioid based Anesthesia; in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery; Procedure: opioid free anesthesia; In this group, patients will not receive any opioids intraoperatively
Active Comparator: Patient does not choose his analgesia strategy; If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA	Procedure: Opioid based Anesthesia; in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery; Procedure: opioid free anesthesia; In this group, patients will not receive any opioids intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery (QoR15)	The primary outcome will be the comparison of early postoperative quality of recovery (QoR) on postoperative day 1 (POD#1) using the validated QoR-15 score (as a whole, and each item separately) between patients who choose vs don't choose their anesthesia strategies. The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery	Postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bradycardia	bradycardia incidence during surgery: defined as a heart rate < 40 per min with concomitant atropine administration (%)	during surgery
Quality of Recovery at postoperative day 2	QoR15 at postoperative day 2 (same as the primary outcome but assessed at POD#2). The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery	Postoperative day 2
PONV incidence	Incidence of postoperative nausea and vomiting defined as the use in percentage of any antiemetic drug in the post-anesthesia care unit (PACU) and from PACU discharge to home discharge (usually between postoperative day 1 and 2)	Postoperative day 2
Anesthesia satisfaction	Anesthesia satisfaction assessment with the Bauer questionnaire. Overall satisfaction and satisfaction by category prevalence (%). Self assessment. It contains 5 questions with 4 categories of answers (very satisfy- satisfy- dissatisfy - very dissatisfy). The proportion of each questions will be compared between groups	Postoperative day 1
Postoperative opioid consumption	opioid consumption in morphine equivalent (mg) from PACU arrival to hospital discharge and from hospital discharge to 30 days post-surgery	Postoperative 30
Postoperative hypoxemia incidence	hypoxemia incidence defined as therapeutic oxygen supplementation to maintain SpO2 > 95% from PACU arrival to postoperative day 2	Postoperative day 2
Health quality of life	Health quality of life on POD#30 with EuroQol5 dimension. Five-level version (EQ-5D-5L score) with visual analogic scale (for each question, you should answer among 5 propositions). The higher score, the better the quality of life of the patient.	Postoperative day 30
Early quality of recovery on POD#1	QoR15 at POD#1 depending on OFA vs OBA, whatever patient preferences. The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery	Postoperative day 1

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Alexandre JOOSTEN, MD PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: quality of recovery; analgesia; postoperative pain; opioids; moderate risk surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid; Anesthetics
• Other Study ID Numbers: IRB-24-5789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No