PO Methadone Ortho Outpatient

Part of paid clinical trials in Los Angeles, California.

Sponsor
Keck School of Medicine of USC
Study ID
NCT06351215
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Arthroscopic Hip Repair
  • Arthroscopic Knee Repair

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methadone group — DRUG
    5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg
  • Placebo — DRUG
    sugar pill that is identical look-alike to study drug

Study Details

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

Key Dates

Start date
May 1, 2025
Status verified
Mar 2025
Primary completion
Dec 1, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
    placebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion
  • Experimental: Interventional
    5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg

Primary Outcome Measure

Post-op opioid usage [ Time Frame: at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USC Healthcare Consultation 3Los AngelesCalifornia90033
Alexander Chen, M.D.
323-442-7400
Abigail Song, B.S. (SUB_INVESTIGATOR)
Benjamin Liu, M.D. (SUB_INVESTIGATOR)
Paul Lee, M.D., M.S. (SUB_INVESTIGATOR)

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