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Opioid
Oral Methadone for Post-Surgery Pain
Phase 3
Waitlist Available
Led By Alexander Chen, M.D.
Research Sponsored by Keck School of Medicine of USC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at post-anesthesia care unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
Awards & highlights
Pivotal Trial
Summary
This trial aims to determine if giving oral methadone before surgery can help reduce post-operative pain and the need for opioid pain medications. Participants will either receive oral methadone or a placebo before surgery
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, common side effects of methadone may include nausea, drowsiness, constipation, lightheadedness, and potential risk of addiction or withdrawal symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at post-anesthesia care unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at post-anesthesia care unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-op opioid usage
Secondary study objectives
Post-op Pain Score
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
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Who is running the clinical trial?
Keck School of Medicine of USCLead Sponsor
6 Previous Clinical Trials
932 Total Patients Enrolled
Alexander Chen, M.D.Principal InvestigatorKeck School of Medicine of USC
5 Previous Clinical Trials
162 Total Patients Enrolled
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