Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-09-15
2026-12-31
Brief Summary
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Detailed Description
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This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80).
Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dextromethorphan
Dextromethorphan Hydrobromide
PO
Placebo
Placebo
PO
Interventions
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Dextromethorphan Hydrobromide
PO
Placebo
PO
Eligibility Criteria
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Inclusion Criteria
* ASA classes I - III
Exclusion Criteria
* History opioid abuse
* History of intractable vomiting after previous surgery
18 Years
ALL
No
Sponsors
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Nathanael Heckmann
OTHER
Responsible Party
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Nathanael Heckmann
Assistant Professor
Locations
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Keck School of Medicine of USC
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Pui Yan, MS
Role: primary
References
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Jones IA, Piple AS, Yan PY, Longjohn DB, Gilbert PK, Lieberman JR, Gucev GV, Oakes DA, Ratto CE, Christ AB, Heckmann ND. A double-blinded, placebo-controlled, randomized study to evaluate the efficacy of perioperative dextromethorphan compared to placebo for the treatment of postoperative pain: a study protocol. Trials. 2023 Mar 29;24(1):238. doi: 10.1186/s13063-023-07240-0.
Other Identifiers
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HS-22-00191
Identifier Type: -
Identifier Source: org_study_id