Dextromethorphan for Treatment of Postoperative Pain

Not Applicable

Recruiting

• Conditions: Post-operative Pain
• Interventions: Drug: Placebo; Drug: Dextromethorphan Hydrobromide

• Registration Number: NCT05278494
• Lead Sponsor: Nathanael Heckmann

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-09-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dextromethorphan	Dextromethorphan Hydrobromide	-

Primary Outcome Measures

Name	Time	Method
Post-op opioid use	24 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	at 48 hours
Subjective pain	preoperatively and 6, 12, 24, and 48 hours postoperatively	numeric rating scale (NRS) or visual analog scale (VAS)

Trial Locations

Locations (1)

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States