100 Participants Needed

Oral Methadone for Post-Surgery Pain

AC
Overseen ByAlexander Chen, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Keck School of Medicine of USC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of the drug methadone for post-surgery pain?

Research shows that methadone can reduce the need for other pain medications after surgery and generally leads to lower pain scores and higher satisfaction with pain relief. However, it is important to consider potential risks like breathing problems and heart rhythm issues.12345

Is oral methadone safe for post-surgery pain management?

Methadone has been shown to reduce the need for other pain medications after surgery and generally provides good pain relief, but it carries risks such as respiratory depression (trouble breathing) and arrhythmia (irregular heartbeat). It is important to weigh these risks against its benefits, and more studies are needed to fully understand its safety compared to other pain treatments.23678

How is the drug methadone unique for post-surgery pain relief?

Methadone is unique for post-surgery pain relief because it has a long-lasting effect, reducing the need for additional pain medication. It works by blocking certain receptors in the brain and also affects serotonin and noradrenaline, which can help manage pain more effectively than some other opioids.134910

What is the purpose of this trial?

The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.Participants will:Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery

Research Team

AC

Alexander Chen, M.D.

Principal Investigator

Keck School of Medicine of USC

Eligibility Criteria

This trial is for individuals scheduled for knee surgery or hip arthroscopy. Participants must meet certain health requirements, which are not specified here. People who do not meet these health standards or have conditions that could interfere with the study's outcomes will be excluded.

Inclusion Criteria

I am scheduled for elective knee or hip surgery and am medically fit for it.

Exclusion Criteria

Allergy to opioids
Pregnant or breastfeeding
I received a nerve block before surgery.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-operative

Participants complete a survey on pain scores and opioid usage; receive either oral methadone or placebo before surgery

1 day
1 visit (in-person)

Intraoperative

Participants receive standard intraoperative pain control; intervention group receives oral methadone

Day of surgery

Post-operative

Participants are monitored in the PACU for pain scores and opioid usage; receive standard PACU medications

1 day

Follow-up

Participants are monitored for pain scores and opioid usage post-discharge; follow-up calls on post-operative day 1 and 2

2 days
2 calls (virtual)

Treatment Details

Interventions

  • Methadone
  • Placebo
Trial Overview The trial is testing if taking oral methadone before surgery can reduce pain and the need for opioids after surgery compared to a placebo (a substance with no drug). Patients will either receive methadone or a placebo and track their pain and opioid use post-surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionalExperimental Treatment1 Intervention
5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg
Group II: ControlPlacebo Group1 Intervention
placebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion

Methadone is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

🇺🇸
Approved in United States as Dolophine for:
  • Pain management
  • Opioid use disorder
🇪🇺
Approved in European Union as Methadose for:
  • Pain management
  • Opioid dependence
🇨🇦
Approved in Canada as Physeptone for:
  • Pain management
  • Opioid use disorder
🇯🇵
Approved in Japan as Heptadon for:
  • Pain management
🇨🇭
Approved in Switzerland as Heptanon for:
  • Pain management
  • Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

Keck School of Medicine of USC

Lead Sponsor

Trials
7
Recruited
1,000+

Findings from Research

In a study of 40 women undergoing lower abdominal surgery, those who received methadone reported significantly lower pain levels and required less additional pain relief compared to those who received morphine, indicating methadone's effectiveness for postoperative analgesia.
Methadone's long plasma half-life (approximately 54 hours) allows for sustained pain relief, making it a safe and effective alternative to morphine without notable side effects.
Postoperative pain control with methadone following lower abdominal surgery.Richlin, DM., Reuben, SS.[2022]
In a meta-analysis of 10 studies involving 617 surgical patients, those who received methadone had significantly lower postoperative opioid consumption compared to those who received other opioids, with a mean difference of -15.22 mg in oral morphine equivalents.
Patients receiving methadone also reported lower pain scores and higher satisfaction with their pain management, although the use of methadone carries risks such as respiratory depression and arrhythmia that need to be considered.
Intraoperative methadone administration and postoperative pain control: a systematic review and meta-analysis.D'Souza, RS., Gurrieri, C., Johnson, RL., et al.[2021]
A single dose of methadone (0.2 mg/kg) given at the start of anesthesia significantly reduced the need for morphine after surgery, with patients using less morphine in the Postanesthesia Care Unit (0 mg vs. 7 mg) and over the first 72 hours (19 mg vs. 35 mg).
Patient satisfaction regarding pain control was high in both the methadone and fentanyl groups, indicating that methadone is an effective option for managing postoperative pain without compromising patient comfort.
A preoperative single dose of methadone for moderate-to-severely painful surgery reduces postoperative morphine consumption.Bastian, K., Buehler, PK., Slizyte, D., et al.[2020]

References

Postoperative pain control with methadone following lower abdominal surgery. [2022]
Intraoperative methadone administration and postoperative pain control: a systematic review and meta-analysis. [2021]
A preoperative single dose of methadone for moderate-to-severely painful surgery reduces postoperative morphine consumption. [2020]
Intraoperative Methadone Reduces Pain and Opioid Consumption in Acute Postoperative Pain: A Systematic Review and Meta-analysis. [2023]
Comparison of oral versus intravenous methadone on postoperative pain and opioid use after adult spinal deformity surgery: A retrospective, non-inferiority analysis. [2023]
Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis. [2023]
Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. [2020]
Methadone for treatment of cancer pain. [2019]
Patient-controlled analgesia with oral methadone in cancer pain: preliminary report. [2020]
[Intraoperative methadone for post-operative pain]. [2021]
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