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NCT Number: NCT05278494

Dextromethorphan for 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Pui Yan, MS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextromethorphan hydrobromide

Drug

PO

Placebo

Drug

PO

Primary outcomes

  1. Post-op opioid use

    Time frame: 24 hours

Secondary outcomes

  1. Subjective pain

    Time frame: preoperatively and 6, 12, 24, and 48 hours postoperatively

    numeric rating scale (NRS) or visual analog scale (VAS)

  2. Postoperative opioid consumption

    Time frame: at 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Yan, MS

CONTACT

[email protected]

323-442-6984

Sponsors and collaborators

Lead sponsor

Nathanael Heckmann

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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