Dextromethorphan for Treatment of Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dextromethorphan Hydrobromide, Placebo.
- Who it may be relevant to
- Registry conditions: Post-operative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain
Overview
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.
Interventions
- Drug Dextromethorphan Hydrobromide
PO - Drug Placebo
PO
Primary outcome measures
- Post-op opioid use [Time frame: 24 hours]
Secondary outcome measures (2)
- Subjective pain [Time frame: preoperatively and 6, 12, 24, and 48 hours postoperatively]
- Postoperative opioid consumption [Time frame: at 48 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Keck School of Medicine of USC — Los Angeles
Publications
- 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 36991450
Identifiers
NCT: NCT05278494 · HS-22-00191