Clinical trial NCT06855641: Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Analgesia
Quality of Recovery (QoR-15)
Outcome Assessment
Opioid Free Anesthesia
Keywords: opioids
quality of recovery
analgesia
moderate risk surgery
postoperative pain
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of recovery (QoR15)
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Quality of Recovery at postoperative day 2
timeFrame: Postoperative day 2
measure: PONV incidence
timeFrame: Postoperative day 2
measure: Anesthesia satisfaction
timeFrame: Postoperative day 1
measure: Postoperative opioid consumption
timeFrame: Postoperative 30
measure: Intraoperative bradycardia
timeFrame: during surgery
measure: Postoperative hypoxemia incidence
timeFrame: Postoperative day 2
measure: Health quality of life
timeFrame: Postoperative day 30
measure: Early quality of recovery on POD#1
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan medical center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Alexandre JOOSTEN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: