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NCT05278494 Clinical Trial

Dextromethorphan for Treatment of Postoperative Pain

Post-operative Pain Clinical Trial

Official title:
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05278494
Other study ID # HS-22-00191
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date December 31, 2025

Study information
Verified date November 2023
Source University of Southern California
Contact Pui Yan, MS
Phone 323-442-6984
Email puiyan@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

Description:

There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA). 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: - Patients Age =18 planning to undergo total knee arthroplasty - ASA classes I - III Main Exclusion Criteria: - BMI = 35 - History opioid abuse - History of intractable vomiting after previous surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dextromethorphan Hydrobromide
PO
• Placebo
PO

Locations
Country Name City State
United States Keck School of Medicine of USC Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Nathanael Heckmann

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-op opioid use 24 hours
Secondary Subjective pain numeric rating scale (NRS) or visual analog scale (VAS) preoperatively and 6, 12, 24, and 48 hours postoperatively
Secondary Postoperative opioid consumption at 48 hours
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