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 — DRUG5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg
- Placebo — DRUGsugar 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: Controlplacebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion
- Experimental: Interventional5mg 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
- Alexander Chen, M.D.323-442-7400
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC Healthcare Consultation 3 | Los Angeles | California | 90033 | Abigail Song, B.S. (SUB_INVESTIGATOR) Benjamin Liu, M.D. (SUB_INVESTIGATOR) Paul Lee, M.D., M.S. (SUB_INVESTIGATOR) |