Opioid-Free vs Opioid-Based Anesthesia for Postoperative Recovery

(PERFECT Trial)

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

240 Participants Needed

Trial Summary

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.

What data supports the effectiveness of opioid-free anesthesia treatment?

Research suggests that opioid-free anesthesia may lead to fewer complications and less nausea and vomiting after surgery compared to opioid-based anesthesia. This approach has been shown to be feasible and potentially beneficial in various surgical settings, including thoracic surgery. ^{1 2 3 4 5}

Is opioid-free anesthesia safe for humans?

Research suggests that opioid-free anesthesia can be safe and may lead to fewer complications compared to opioid-based anesthesia. It has been shown to reduce opioid-related side effects and is considered feasible in various surgeries, although more studies are needed to fully understand its safety across different procedures. ^{5 6 7 8 9}

How does opioid-free anesthesia differ from opioid-based anesthesia for postoperative recovery?

Opioid-free anesthesia uses drugs like dexmedetomidine and lidocaine instead of opioids, aiming to control pain while reducing side effects like nausea and vomiting that are common with opioid-based anesthesia. ^{1 3 4 8 10}

What is the purpose of this trial?

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.

Research Team

Alexandre JOOSTEN, MD PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

My health is graded between I-IV for surgery readiness.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of opioid-free anesthesia on the incidence of postoperative nausea and vomiting: A meta-analysis of randomized controlled studies. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Outcomes for 41 260 pediatric surgical patients with opioid-free anesthesia: One center's experience. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia: A systematic review and meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid Free Anesthesia in Thoracic Surgery: A Systematic Review and Meta Analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Opioid-Sparing Techniques in Orthopedic Anesthesia-One Step to Opioid-Free Anesthesia? [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

[Guiding opioid-free intravenous antinociception with the Analgesia Nociception Index: a case report]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Total opioid-free general anaesthesia can improve postoperative outcomes after surgery, without evidence of adverse effects on patient safety and pain management: A systematic review and meta-analysis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia for postoperative recovery after video-assisted thoracic surgery: A prospective, randomized controlled trial. [2023]