Methadone for Postoperative Pain
(MELODY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether using methadone, a long-acting opioid, during surgery can improve pain control and recovery afterward. Methadone may provide better and longer-lasting pain relief compared to usual short-acting opioids. The study compares a single dose of methadone to standard opioid treatments during surgery. Individuals planning for non-heart-related surgery and expecting to stay in the hospital for at least a day might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids regularly, you may not be eligible to participate.
Is there any evidence suggesting that methadone is likely to be safe for humans?
Research has shown that using methadone during surgery is generally safe for managing postoperative pain. Studies found that patients who received methadone experienced side effects, such as nausea and vomiting, similar to those who took other pain medications. Importantly, methadone does not increase the risk of serious breathing problems compared to other short-acting painkillers.
Additionally, patients who took methadone often required fewer additional pain medications after surgery and reported less pain. This suggests that methadone could be a well-tolerated option for pain control, offering benefits for recovery.12345Why do researchers think this study treatment might be promising for postoperative pain?
Unlike the standard of care, which typically involves short-acting opioids like fentanyl or hydromorphone, methadone-based anesthesia offers a unique approach to managing postoperative pain. Methadone is a long-acting opioid, which means it could provide more sustained pain relief with fewer doses. This could potentially reduce the need for additional opioids during surgery and minimize the risk of opioid-related side effects. Researchers are excited about methadone's potential to improve pain management outcomes and enhance patient recovery experiences.
What evidence suggests that methadone might be an effective treatment for postoperative pain?
Research has shown that methadone effectively manages pain after surgery. In this trial, participants in the experimental arm will receive methadone-based anesthesia. Studies have found that patients who received methadone during surgery reported less pain than those who received other painkillers like fentanyl or morphine. Specifically, one study showed that patients who took methadone experienced much lower pain levels at their first follow-up visit after surgery. Another study found that methadone reduced the need for additional pain medication post-surgery. Methadone affects pain signals in the brain and lasts longer, aiding in better pain control and a smoother recovery.24678
Who Is on the Research Team?
Joseph Szokol, MD PhD
Principal Investigator
University of California, Los Angeles
EVAN KARASCH, MD PhD
Principal Investigator
DUKE
Are You a Good Fit for This Trial?
This trial is for adults (18+) having planned, moderate-risk non-heart surgery under general anesthesia who are expected to stay in the hospital at least a day. People can't join if they use opioids regularly, have severe liver or kidney problems, are pregnant or breastfeeding, plan on regional anesthesia, or are allergic to methadone/opioids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intravenous methadone at induction or standard short-acting opioid-based anesthesia during surgery
Postoperative Monitoring
Participants are monitored for quality of recovery and opioid-related adverse events
Follow-up
Participants' health-related quality of life is assessed using EQ-5D-5L
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
Trial Overview
The study compares giving a single IV dose of methadone at the start of surgery versus standard short-acting opioid painkillers during surgery. Patients are randomly assigned and don't know which treatment they get. The goal is to see if methadone improves recovery after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Intervention: Drug: Methadone Intravenous methadone 0.25 mg/kg (ideal body weight) administered at induction Optional supplemental dose (2 mg) at emergence if clinically indicated Additional intraoperative short-acting opioids discouraged
Intervention: Drug: Short-acting opioids Fentanyl and/or hydromorphone administered intraoperatively according to clinician judgment Reflects usual care practice
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexandre P. Joosten
Lead Sponsor
Citations
Intraoperative methadone for postoperative pain in adult ...
This study hypothesised that methadone would provide superior postoperative pain relief and reduced opioid consumption compared with fentanyl.
The Role of Methadone in Postoperative Analgesia ...
At the first postoperative clinic visit, however, the methadone group reported significantly lower pain scores (p = 0.009), exceeding the MCID threshold for NRS ...
A Meta-Analysis of Randomized Controlled Trials - PMC
The use of intraoperative methadone reduces postoperative pain when compared to morphine. In addition, the beneficial effect of methadone on postoperative pain ...
The Impact of Intraoperative Methadone on Postoperative ...
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and ...
Review Intraoperative Utilization of Intravenous Methadone ...
This review supports that incorporating intravenous methadone can yield a satisfactory analgesic profile for a wide array of surgeries, including ambulatory ...
Intraoperative methadone for postoperative pain management
Several recent trials have reported that intraoperative IV methadone is associated with significantly better postoperative analgesia. However, such studies are ...
Intraoperative methadone for postoperative pain in adult ...
This study hypothesised that methadone would provide superior postoperative pain relief and reduced opioid consumption compared with fentanyl.
Clinical effectiveness and safety of intraoperative ...
In this randomised, blinded, controlled trial, opioid consumption was reduced during the first 24 postoperative hours in patients receiving methadone without ...
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