Dextromethorphan for Treatment of Postoperative Pain

Nathanael Heckmann

Status: Enrolling

Conditions: Post-operative Pain

Treatments: Drug: Placebo; Drug: Dextromethorphan Hydrobromide

Study type: Interventional

Funder types: Other

Identifiers

NCT05278494

HS-22-00191

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Dextromethorphan

Experimental group

Treatment:

Drug: Dextromethorphan Hydrobromide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo