Post-operative Pain
Conditions
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.
Interventions
DRUGPlacebo
PO
Sponsors
Nathanael Heckmann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-op opioid use | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Contacts
CONTACTPui Yan, MS
Outcome results
None listed