Methadone for Postoperative Pain after Spinal Surgery

(MEND Trial)

Overseen By Sandra Durbin, CLPN, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Disqualifiers: Age, BMI, Methadone allergy, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether methadone can safely reduce the need for other pain medications after spine surgery. Researchers aim to determine if methadone can ease pain and decrease reliance on opioids (strong painkillers) three months post-surgery. Participants will receive either methadone or a placebo (a pill with no active drug) after their surgery. The trial seeks individuals scheduled for a specific type of spine surgery called multilevel lumbar or thoracic spine fusion. As a Phase 4 trial, methadone is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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

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

What is the safety track record for methadone?

Research has shown that methadone is generally safe for managing pain after surgery. Studies have found that it can cause mild to moderate slowed breathing, but proper monitoring can control this. Other research indicates that methadone reduces pain and the need for additional opioids after surgery. It is already used effectively in surgeries for pain management. This trial aims to confirm methadone as a safe option for patients recovering from spine surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Methadone is unique because it offers a long-acting option for managing postoperative pain after spinal surgery, potentially reducing the need for frequent dosing. While traditional opioids like morphine or oxycodone are commonly used, they often require multiple doses throughout the day. Methadone, on the other hand, maintains its pain-relieving effects with less frequent dosing, which could improve patient compliance and comfort. Researchers are excited about methadone because it might minimize the rollercoaster of pain and relief that patients often experience with shorter-acting opioids, providing a steadier control of pain.

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

Studies have shown that methadone can effectively manage pain after surgery, particularly for spine surgeries. In this trial, participants will receive either methadone or a placebo at random. Methadone lowers pain levels and reduces the need for other pain-relief drugs, such as opioids. Its longer duration of action helps maintain pain control for extended periods. Research also suggests that it decreases the amount of additional pain medication required after surgery. Overall, methadone is recognized for its potential to manage post-surgical pain effectively. ^{2 3 5 6 7}

Who Is on the Research Team?

Andra Duncan, MD

Principal Investigator

The Cleveland Clinic

Shobana Rajan, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients experiencing pain after major spine surgery. Participants must be adults who have undergone spinal surgery and are expected to need opioid pain medication postoperatively. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a spine fusion surgery in my lower back or mid-back.

Exclusion Criteria

Body Mass Index >40

Known allergy to methadone

Pregnant females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either methadone or placebo for 5 days post-surgery

1 week

Daily visits during hospitalization

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and opioid use reduction

3 months

Regular follow-up visits

Long-term follow-up

Assessment of chronic opioid use reduction and study design parameters for future trials

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview The MEND study tests if methadone can help reduce the need for opioids after spine surgery compared to a placebo. It's a small-scale, preliminary study where participants are randomly assigned to receive either methadone or a placebo without knowing which one they get.

How Is the Trial Designed?

Group I: Patients randomized to receive (blinded) methadone. Active Control 1 Intervention

Methadone group: Patients randomized to receive (blinded) methadone will receive methadone 5 mg twice daily on postoperative days 1 and 2 followed by 5 mg daily on postoperative days 3, 4, and 5. Patients taking preoperative opioids will be able to return to their baseline opioids immediately after surgery

Group II: Patients randomized to receive (blinded) placebo Placebo Group 1 Intervention

Patients randomized to receive (blinded) placebo will receive placebo tablets twice daily on day 1 and day 2 and once daily on day 3, 4 and 5. Patients taking preoperative opioids will return to their baseline opioid schedule after surgery.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12524262/

Perioperative Methadone in Orthopedic Surgery: A Scoping ... Conclusions: Perioperative methadone is an effective analgesic adjunct that reduces postoperative pain and opioid requirements, especially in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07092475

The Impact of Intraoperative Methadone on Postoperative ... Unlike short-acting opioids, a single dose of methadone given intraoperatively has been shown to be capable of maintaining analgesic levels for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772609625000425

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.

4. journals.lww.com journals.lww.com/spinejournal/abstract/9900/the_effect_of_intraoperative_methadone_during.1113.aspx

The Effect of Intraoperative Methadone During Spine ... Results showed no significant difference in opioid use or pain levels among the groups at 6 and 24 hours post-surgery, except for slightly lower pain at 48 and ...

5. link.springer.com link.springer.com/article/10.1007/s40140-024-00662-9

The Role of Methadone and Regional Anesthesia in ... Studies showed that methadone lowers pain scores and postoperative opioid requirements in patients undergoing major spine surgery [9,10,11]. In ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6383150/

Safety profile of intraoperative methadone for analgesia ... Mild-moderate respiratory depression is observed following a onetime dose of intraoperative methadone, and monitoring in an appropriate postoperative setting ...

7. mdpi.com mdpi.com/2227-9032/13/19/2431

Perioperative Methadone in Orthopedic Surgery A recent scoping review revealed that perioperative methadone use during spinal surgeries was associated with significantly lower postoperative pain scores and ...