Methadone for Postoperative Pain

Overseen By Haley Nitchie, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Medical University of South Carolina

Disqualifiers: Severe liver disease, Renal disease, QT syndrome, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 25

Duration: 1 day

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether methadone can reduce pain and the need for other opioids after knee replacement surgery. Participants will either receive methadone during surgery or not, allowing researchers to compare outcomes. The trial seeks individuals undergoing elective knee replacement surgery with spinal anesthesia using mepivacaine. Those with allergies to methadone or mepivacaine, severe liver or kidney issues, or certain heart problems may not qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking pain management solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that methadone is likely to be safe for humans?

Research shows that methadone can safely manage pain after surgery. Studies have found that patients receiving methadone during surgery reported less pain afterward and required fewer additional painkillers. For instance, one study found that those given methadone experienced lower pain levels and greater satisfaction with their pain relief.

Regarding safety, methadone has been used for pain management in other contexts, suggesting it is generally well-tolerated. However, like any medication, it can cause side effects. Some studies have noted risks such as nausea and vomiting. These factors should be considered when determining if methadone is appropriate. Discuss potential benefits and risks with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Methadone is unique because it offers a potentially more effective way to manage postoperative pain compared to standard options like morphine or oxycodone. It has a longer duration of action, which means patients might experience pain relief for an extended period with fewer doses. Additionally, methadone works by targeting both opioid receptors and NMDA receptors, which could help in managing pain more comprehensively and possibly reducing the development of tolerance. Researchers are excited about methadone because it could provide better pain control with a lower risk of side effects and addiction.

What evidence suggests that methadone might be an effective treatment for postoperative pain?

Research has shown that methadone can help reduce pain immediately after surgery. In several studies, patients who received methadone reported feeling less pain upon waking. In this trial, some participants will receive methadone during surgery, while others will not. Methadone has also decreased the need for other pain medications post-surgery. One study found that patients given methadone used fewer opioids, which are strong painkillers. This suggests that methadone might better manage pain and reduce the need for additional pain medications. ^{2 3 4 6 7}

Who Is on the Research Team?

William Barrett, M.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are having knee replacement surgery with a specific spinal anesthesia. It's not for those with heart rhythm issues, allergies to the drugs being tested, severe liver disease, pregnancy, kidney failure requiring dialysis, or inability to consent.

Inclusion Criteria

Inclusion

This section is for criteria that would disqualify me from participating.

I am allergic to methadone or mepivacaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with intraoperative IV methadone administration

1 day

1 visit (in-person, surgery day)

Immediate Postoperative Monitoring

Participants are monitored for pain, opioid consumption, and recovery quality in the PACU

up to 24 hours

Continuous monitoring in PACU

Follow-up

Participants are monitored for postoperative nausea, vomiting, and pain scores

72 hours

Monitoring at 24, 48, and 72 hours post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview

The study tests if giving methadone during surgery can lessen pain and reduce the need for opioids after knee replacement. Participants are randomly assigned to receive either methadone or a placebo without knowing which one they get.

How Is the Trial Designed?

Group I: Methadone Active Control 1 Intervention

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Group II: No Methadone Active Control 1 Intervention

Patients will NOT receive methadone.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7140144/

A Meta-Analysis of Randomized Controlled Trials - PMC

Patients in the methadone group reported less pain in the immediate postoperative phase (e.g., PACU). In addition, patients also reported a ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772609623000989

Clinical effectiveness and safety of intraoperative ...

Methadone only reduced postoperative pain at PACU arrival compared with morphine, and the observed side-effects and the proportion of same-day discharge were ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07092475

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 ...

4.

jopan.org

jopan.org/article/S1089-9472(21)00319-1/fulltext

Rediscovery of Methadone to Improve Outcomes in Pain ...

Methadone may help improve pain management in patients undergoing spine surgery. For instance, a single dose of methadone (0.2 mg/kg) before ...

5.

academic.oup.com

academic.oup.com/jbcr/advance-article/doi/10.1093/jbcr/iraf209/8315120

Intraoperative Intravenous Methadone and Postoperative ...

Data on opioid and non-opioid pain medications and respective doses were recorded for 3 time periods/locations: intraoperative, post-anesthesia care unit ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12428596/

The Role of Methadone in Postoperative Analgesia in ... - PMC

3.3.​​ At the first postoperative clinic visit, however, the methadone group reported significantly lower pain scores (p = 0.009), exceeding the ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31613867/

a systematic review and meta-analysis

Patients in the methadone group generally reported lower postoperative pain scores in 7 of 10 studies. Meta-analysis revealed greater satisfaction scores with ...