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Clinical Trials/NCT06855641
NCT06855641CompletedNot Applicable

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)

University of California, Los Angeles2 sites in 1 country240 target enrollmentStarted: March 24, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
2
Primary Endpoint
Quality of recovery (QoR15)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

quality of recovery will be done by research coordinators and research students ( undergraduate students) not involved in patient care.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Patient choose his analgesia type

Experimental

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

Intervention: Opioid based Anesthesia (Procedure)

Patient choose his analgesia type

Experimental

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

Intervention: opioid free anesthesia (Procedure)

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

Intervention: Opioid based Anesthesia (Procedure)

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

Intervention: opioid free anesthesia (Procedure)

Outcomes

Primary Outcomes

Quality of recovery (QoR15)

Time Frame: Postoperative day 1

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

Secondary Outcomes

  • 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)
  • Postoperative hypoxemia incidence(Postoperative day 2)
  • Health quality of life(Postoperative day 30)
  • Early quality of recovery on POD#1(Postoperative day 1)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexandre P. Joosten

Associate Professor

University of California, Los Angeles

Study Sites (2)

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