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PO Methadone Ortho Outpatient

NCT06351215 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-05

No results posted yet for this study

Summary

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

Conditions

  • Arthroscopic Knee Repair
  • Arthroscopic Hip Repair

Interventions

DRUG

Methadone group

5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg

DRUG

Placebo

sugar pill that is identical look-alike to study drug

Sponsors & Collaborators

  • Keck School of Medicine of USC

    lead OTHER

Principal Investigators

  • Alexander Chen, M.D. · Keck School of Medicine of USC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-12-01
Completion
2025-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351215 on ClinicalTrials.gov