Dextromethorphan for Treatment of Postoperative Pain

Sponsor

Nathanael Heckmann (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05278494

Collaborator

(none)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain	Drug: Dextromethorphan Hydrobromide Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Dextromethorphan

Drug: Dextromethorphan Hydrobromide

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Post-op opioid use [24 hours]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nathanael Heckmann

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nathanael Heckmann, Assistant Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT05278494

Other Study ID Numbers:

HS-22-00191

First Posted:

Mar 14, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Dextromethorphan

Study Results

No Results Posted as of Jun 6, 2022