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, Prolonged QT, 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 explores whether methadone, administered during surgery, can reduce pain and the need for other opioids after hip replacement surgery. Researchers aim to determine if patients experience less pain shortly after surgery and use fewer painkillers overall. The trial is for individuals undergoing planned hip replacement surgery who are not allergic to methadone or mepivacaine and do not have severe liver or kidney issues. Participants will either receive methadone during their surgery or not, allowing for a comparison of results. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain management.

Do I need to stop my current medications to join 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 has shown that methadone can help manage pain after surgery. Patients who received methadone during their operation reported less pain than those who did not. Many studies also found that these patients were more satisfied with their pain management.

Regarding safety, methadone is usually well-tolerated during surgery. Side effects like nausea or vomiting are similar to those seen with other pain medications, indicating that methadone is about as safe as the usual pain treatments used during and after surgery.

While methadone is a strong pain reliever, it's important to consider personal health conditions and discuss them with a doctor. Methadone is already approved by the FDA for other uses, which adds confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Methadone is unique for postoperative pain management because it offers long-lasting pain relief with a single dose. Unlike traditional opioids like morphine or fentanyl, which often require frequent dosing, methadone can provide extended relief, reducing the need for multiple doses. Researchers are excited about methadone's potential to improve patient comfort and streamline pain management protocols, lowering the risk of complications associated with repeated opioid administration.

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

Studies have shown that methadone effectively reduces pain immediately after surgery. Patients often experience less pain upon arriving in the recovery room. Research also indicates that methadone can decrease the need for other painkillers post-surgery. Some studies found that methadone provided better pain relief than morphine at this stage. In this trial, one group of patients will receive methadone during surgery, while another group will not. Overall, methadone appears to be a promising option for managing pain after surgeries like hip replacements. ^{2 3 4 6 7}

Who Is on the Research Team?

Christopher Fatora, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Adults aged 18-75 scheduled for elective hip replacement surgery with mepivacaine spinal anesthesia can join. Excluded are those allergic to methadone or mepivacaine, with severe liver disease, end-stage kidney disease on dialysis, unable to consent, diagnosed with prolonged QT syndrome, or pregnant.

Inclusion Criteria

Inclusion

I am between 18 and 75 years old.

I am scheduled for a first-time hip replacement with mepivacaine spinal anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative intravenous methadone or no methadone during total hip arthroplasty

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for pain and opioid consumption in the PACU

up to 24 hours

Continuous monitoring in PACU

Follow-up

Participants are monitored for pain scores, opioid consumption, quality of recovery, and incidence of nausea/vomiting

72 hours

Follow-up assessments at 24, 48, and 72 hours post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview

The trial is testing if methadone given through an IV during surgery can lessen pain and reduce the need for opioids after hip replacement. Patients' pain levels and opioid use are measured afterwards along with side effects like nausea and overall recovery quality.

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 ...

An alternative option for managing acute and chronic burn pain is the long-acting opioid, methadone. Methadone is an attractive medication for several reasons.

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 ...