Opioid-Free vs Opioid-Based Anesthesia for Postoperative Recovery

(PERFECT Trial)

No longer recruiting at 1 trial location

Overseen By Yann Gricourt, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Opioids

Disqualifiers: Chronic pain, Pregnancy, Mental disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how patients' choices about pain relief during surgery affect their recovery. It compares traditional opioid-based anesthesia with an alternative approach that avoids opioids. Participants will either choose their anesthesia type or receive a random assignment. The trial is ideal for individuals undergoing planned, moderate-risk robotic or laparoscopic abdominal surgeries who are not currently using prescribed opioids. As an unphased trial, it offers a unique opportunity to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already prescribed opioids before the surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that anesthesia without opioids is generally safe for patients. Studies suggest that this type of anesthesia can lead to faster recovery and less nausea and vomiting after surgery. No evidence indicates it is less safe than traditional opioid-based anesthesia. Patients often feel more comfortable and experience less pain with opioid-free anesthesia.

Conversely, using opioids in anesthesia remains the standard method and is also considered safe. Many studies have compared the two methods, finding no significant difference in safety. Both types of anesthesia effectively relieve pain.

Overall, both opioid-free and opioid-based anesthesia are well-tolerated, with no major safety concerns reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA) for postoperative recovery because it could lead to significant changes in managing pain after surgery. Unlike traditional methods that rely heavily on opioids, OFA uses alternative medications to control pain, potentially reducing the risk of opioid addiction and side effects like nausea and constipation. This trial could show that OFA is just as effective, or even more effective, in ensuring a smoother recovery without the drawbacks of opioids. By exploring these two approaches, researchers hope to offer patients safer and more personalized options for pain management.

What evidence suggests that this trial's treatments could be effective for postoperative recovery?

This trial will compare opioid-free anesthesia (OFA) with opioid-based anesthesia (OBA) for postoperative recovery. Research has shown that OFA can enhance recovery after surgery. Specifically, studies found that OFA improves physical comfort and reduces pain 24 hours post-surgery. It also significantly lowers the risk of nausea and vomiting compared to OBA. However, some studies found no significant difference between OFA and OBA in pain reduction within the first 24 hours after surgery. Overall, OFA appears to aid recovery by increasing comfort and reducing side effects like nausea. Participants in this trial may choose their type of analgesia or be randomized to receive either OFA or OBA. ^{1 3 6 7 8}

Who Is on the Research Team?

Alexandre JOOSTEN, MD PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for patients scheduled for moderate risk laparoscopic/robotic abdominal surgery. It's designed to see if people prefer opioid-free anesthesia or traditional opioid-based methods, and how their choice affects recovery after surgery.

Inclusion Criteria

I am older than 18 years.

Informed consent signed

English speaking

Exclusion Criteria

Pregnancy or lactation

I have been prescribed opioids before surgery.

I am not allergic or unable to take lidocaine, magnesium, dexmedetomidine, or ketamine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo moderate risk laparoscopic/robotic abdominal surgery with either opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA), based on patient preference or randomization

During surgery

1 visit (in-person)

Immediate Postoperative Recovery

Participants are monitored for early postoperative quality of recovery and incidence of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit (PACU)

1-2 days

Inpatient stay

Follow-up

Participants are monitored for quality of recovery, opioid consumption, and health quality of life up to 30 days post-surgery

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-based Anesthesia
• Opioid-free Anesthesia

Trial Overview The study tests two types of anesthesia: one without opioids (OFA) and the other with them. Patients' preferences are considered to understand the impact on postoperative recovery quality following abdominal surgery.

How Is the Trial Designed?

Group I: Patient choose his analgesia type Experimental Treatment 2 Interventions

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

Group II: Patient does not choose his analgesia strategy Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 303 patients undergoing elective abdominal colorectal surgery, approximately 67.7% were able to avoid opioid use after leaving the postanesthesia care unit, demonstrating the feasibility of an opioid-free analgesia protocol.

Patients who successfully avoided opioids tended to be older, had fewer complications, and experienced shorter hospital stays, suggesting that certain demographic and clinical factors may contribute to the success of opioid-free surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? Yap, R., Nassif, G., Hwang, G., et al.[2021]

A systematic review of 38 studies involving patients undergoing general anesthesia found no significant difference in acute pain scores or opioid consumption between opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA).

Patients receiving opioid-free anesthesia reported better quality of recovery and experienced less postoperative nausea and vomiting, although they had a higher incidence of bradycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia: A systematic review and meta-analysis. Feenstra, ML., Jansen, S., Eshuis, WJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351777/

Effectiveness and safety of opioid-free anesthesia compared ... No OFA regimens showed a statistically significant effect over OBA in reducing postoperative pain within the first 24 h following surgery.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352556824001115

Opioid-free anaesthesia and postoperative quality of ... The meta-analysis indicate OFA can improve the quality of recovery at postoperative 24 h, particularly in terms of enhancing physical comfort and reducing pain.

3. authorea.com authorea.com/doi/full/10.22541/au.176241500.00115527/v1

A Systematic Review and Bayesian Network Meta-Analysis OSA also showed potential benefits when compared to OBA, primarily in decreasing the incidence of intraoperative bradycardia (lnOR = 1.77, 95% ...

4. frontiersin.org frontiersin.org/journals/anesthesiology/articles/10.3389/fanes.2025.1714040/full

Opioid-free anesthesia: a scoping review of efficacy, safety, ... No difference in postoperative recovery outcomes between opioid-free and opioid-sparing anesthesia under multimodal analgesic protocol for ...

5. digitalcommons.kansascity.edu digitalcommons.kansascity.edu/cgi/viewcontent.cgi?article=2141&context=studentpub

Opioid-free Anesthesia: a Scoping Review of Efficacy, ... Results: Across 23 randomized controlled trials and one cohort study, OFA consistently reduced PONV, while demonstrating analgesia and recovery.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0952818025003198

Opioid-free versus opioid-based anaesthesia and ... Total opioid-free general anaesthesia can improve postoperative outcomes after surgery, without evidence of adverse effects on patient safety and pain ...

7. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/effect-of-opioid-free-anesthesia-on-postoperative-recovery-in-major-abdominal-surgeries-3241/

Effect of Opioid-Free Anesthesia on Postoperative ... Opioid-free anesthesia significantly improves postoperative recovery in major abdominal surgeries by enhancing analgesia, accelerating functional recovery.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380946/

Effect of Opioid-Free Versus Opioid Anesthesia on the Quality ... OFA significantly improved postoperative recovery quality as evidenced by higher QOR-15 scores, reduced postoperative nausea and vomiting (PONV) ...