30 Participants NeededMy employer runs this trial

Methadone for Postoperative Pain

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Brandon Knopp
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether methadone, administered immediately after anesthesia, can better control pain during and after spine surgery compared to standard painkillers. The researchers aim to determine if methadone use can reduce the need for other opioids and speed up patient recovery. The study involves two groups: one receiving methadone and the other receiving standard opioid pain management. Suitable candidates for this trial include those undergoing planned spine surgery, such as spinal fusion, with an expected hospital stay afterward. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have an opioid use disorder and are on stable maintenance therapy, you may still be included in the trial.

What is the safety track record for methadone?

Research has shown that using methadone during surgery can help manage postoperative pain. Patients often experience less pain and require fewer additional pain medications. One study found that those who received methadone during surgery reported lower pain levels and needed fewer strong painkillers afterward.

Many studies have examined methadone's safety in these situations. Some individuals might experience mild to moderate respiratory depression, characterized by slower or shallower breathing. However, these issues are typically mild and can be effectively monitored in a hospital setting.

Overall, methadone appears to be a safe option for managing pain during and after surgery, reducing the need for extra pain medications without causing major side effects.12345

Why are researchers enthusiastic about this study treatment?

Methadone stands out for postoperative pain management because it works differently from traditional opioids like morphine or oxycodone. Unlike these standard options, methadone has a unique mechanism of action, as it not only targets the usual opioid receptors for pain relief but also blocks NMDA receptors, which are involved in pain pathways and can reduce the development of tolerance. Additionally, methadone's longer half-life means it provides extended pain relief, potentially reducing the need for frequent dosing. Researchers are excited about methadone because it could lead to better pain control with fewer doses, offering a promising alternative for patients recovering from surgery.

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

Research has shown that methadone can help manage pain after surgery. In this trial, some participants will receive methadone, while others will receive standard pain management. One study found that patients who received methadone reported less pain immediately after surgery compared to those who received other painkillers like fentanyl. Another study found that people taking methadone had lower pain levels at their first follow-up visit. A review of several studies noted that methadone often provides better pain relief for various types of surgeries. Additionally, methadone can safely reduce the need for other painkillers after surgery. Overall, methadone has shown promising results for improving pain management post-surgery.23456

Are You a Good Fit for This Trial?

This trial is for adults having planned (elective) spine surgery who will stay in the hospital after their operation and can give informed consent. People with stable opioid use disorder on maintenance therapy may also join.

Inclusion Criteria

* Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy
I am scheduled for elective spine surgery.
* Expected postoperative inpatient admission
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard intraoperative opioid regimen or methadone post-induction during spine surgery

Perioperative period
1 visit (in-person, surgery day)

Postoperative Monitoring

Participants are monitored for pain control, opioid use, and recovery outcomes including respiratory depression and nausea

72 hours
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and hospital length of stay

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Methadone

Trial Overview

The study compares giving a single dose of methadone during anesthesia to standard pain medicine during spine surgery, to see which better controls pain and reduces the need for other opioids after surgery. Patients are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MethadoneExperimental Treatment1 Intervention
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brandon Knopp

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

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

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 ...

6.

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 ...