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

NCT06855641 | Completed

• 1 other identifier: IRB-24-5789
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Opioid Analgesia; Quality of Recovery (QoR-15); Outcome Assessment; Opioid Free Anesthesia

Keywords

opioids; quality of recovery; analgesia; moderate risk surgery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of Recovery at postoperative day 2

  Postoperative day 2

• PONV incidence

  Postoperative day 2

• Anesthesia satisfaction

  Postoperative day 1

• Postoperative opioid consumption

  Postoperative 30

• Intraoperative bradycardia

  during surgery

Study Arms (2)

Patient choose his analgesia type

EXPERIMENTAL

The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)

Procedure: Opioid based Anesthesia; Procedure: opioid free anesthesia

Patient does not choose his analgesia strategy

ACTIVE COMPARATOR

If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA

Procedure: Opioid based Anesthesia; Procedure: opioid free anesthesia

Interventions

Opioid based Anesthesia PROCEDURE

in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery

Patient choose his analgesia type; Patient does not choose his analgesia strategy

opioid free anesthesia PROCEDURE

In this group, patients will not receive any opioids intraoperatively

Patient choose his analgesia type; Patient does not choose his analgesia strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Ronald Reagan medical center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Gricourt Y, Boulos NM, Delaporte A, Alexander B, Besada S, Bakhit R, Toukhtarian A, Neuman I, Pearce D, Nourian MM, Chebishian A, Zhou A, Boktor J, Mayanja D, Grogan T, Boldt D, Cannesson M, Forget P, Joosten A. 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). BJA Open. 2025 Jun 18;15:100420. doi: 10.1016/j.bjao.2025.100420. eCollection 2025 Sep.

  PMID: 40607110 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Alexandre JOOSTEN, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: quality of recovery will be done by research coordinators and research students ( undergraduate students) not involved in patient care.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 24, 2025
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-03

Locations

US (2)