Back to resultsDextromethorphan for Treatment of Postoperative Pain
Primary Purpose
Post-operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan Hydrobromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain
Eligibility 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
Sites / Locations
- Keck School of Medicine of USCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dextromethorphan
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Post-op opioid use
Secondary Outcome Measures
Subjective pain
numeric rating scale (NRS) or visual analog scale (VAS)
Postoperative opioid consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05278494
Brief Title
Dextromethorphan for Treatment of Postoperative Pain
Official Title
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nathanael Heckmann
4. Oversight
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
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dextromethorphan
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan Hydrobromide
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PO
Primary Outcome Measure Information:
Title
Post-op opioid use
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Subjective pain
Description
numeric rating scale (NRS) or visual analog scale (VAS)
Time Frame
preoperatively and 6, 12, 24, and 48 hours postoperatively
Title
Postoperative opioid consumption
Time Frame
at 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Yan, MS
Phone
323-442-6984
Email
puiyan@med.usc.edu
Facility Information:
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Yan, MS
Email
puiyan@med.usc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Dextromethorphan for Treatment of Postoperative Pain
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