NCT05278494

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

March 3, 2022

Last Update Submit

March 26, 2026

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post-op opioid use

    24 hours

Secondary Outcomes (2)

  • Subjective pain

    preoperatively and 6, 12, 24, and 48 hours postoperatively

  • Postoperative opioid consumption

    at 48 hours

Study Arms (2)

Dextromethorphan

EXPERIMENTAL
Drug: Dextromethorphan Hydrobromide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Dextromethorphan HydrobromideDRUG

PO

Dextromethorphan
PlaceboDRUG

PO

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients Age ≥18 planning to undergo total knee arthroplasty
  • ASA classes I - III

You may not qualify if:

  • BMI ≥ 35
  • History opioid abuse
  • History of intractable vomiting after previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (1)

  • Jones IA, Piple AS, Yan PY, Longjohn DB, Gilbert PK, Lieberman JR, Gucev GV, Oakes DA, Ratto CE, Christ AB, Heckmann ND. A double-blinded, placebo-controlled, randomized study to evaluate the efficacy of perioperative dextromethorphan compared to placebo for the treatment of postoperative pain: a study protocol. Trials. 2023 Mar 29;24(1):238. doi: 10.1186/s13063-023-07240-0.

    PMID: 36991450DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Pui Yan, MS

CONTACT

323-442-6984puiyan@med.usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

September 15, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)