Impact of patient choice on opioid use during surgery and recovery quality
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)
This study is testing whether letting patients choose between traditional opioid pain relief and opioid-free options during surgery can improve their recovery experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06855641 on ClinicalTrials.gov |
What this trial studies
This study investigates how patient preferences regarding opioid use during surgery affect their early postoperative recovery quality. It compares traditional opioid-based anesthesia with opioid-free anesthesia, which utilizes alternative analgesics to minimize opioid exposure. The research aims to empower patients through shared decision-making about their pain management options, potentially improving recovery outcomes. By focusing on moderate risk laparoscopic and robotic surgeries, the study seeks to address the growing concerns surrounding opioid addiction and its side effects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing elective intermediate risk surgeries under general anesthesia who can provide informed consent.
Not a fit: Patients with chronic pain, those on preoperative opioids, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative recovery experiences and reduce opioid-related complications for patients.
How similar studies have performed: While the approach of opioid-free anesthesia is gaining traction, this specific evaluation of patient preference in relation to opioid use is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 1 other locations
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (Recruiting)
- UCLA Ronald Reagan medical center — Los Angeles, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexandre JOOSTEN, MD PhD — University of California, Los Angeles
- Study coordinator: Alexandre JOOSTEN JOOSTEN, MD PhD
- Email: ajoosten@mednet.ucla.edu
- Phone: 3109627337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.