Dextromethorphan for Treatment of Postoperative Pain

March 26, 2026 updated by: Nathanael Heckmann

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine of USC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
PO
Experimental: Dextromethorphan
Drug: Dextromethorphan Hydrobromide
PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-op opioid use
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective pain
Time Frame: preoperatively and 6, 12, 24, and 48 hours postoperatively
numeric rating scale (NRS) or visual analog scale (VAS)
preoperatively and 6, 12, 24, and 48 hours postoperatively
Postoperative opioid consumption
Time Frame: at 48 hours
at 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nathanael Heckmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-22-00191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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