Evaluating Suzetrigine for Pain Control Following TKA
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Postoperative Pain Following Knee Arthroplasty
In brief
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. The main questions it aims to answer are: Does suzetrigine lower the amount of opioid pain medicine participants use after surgery? Does suzetrigine have any effect on postoperative patient-reported outcomes, including pain scores, range of motion, length of stay, and KOOS/PROMIS surveys? Researchers will compare suzetrigine to a placebo to see if suzetrigine works to treat pain after total knee replacement surgery. Participants will: Take suzetrigine or a placebo by mouth for 14 days after surgery Receive standard pain care, including opioid pain medicine only if needed Report their pain levels using short daily surveys Attend routine follow-up visits after surgery
Key facts
- Study ID
- NCT07357376
- Run by
- AdventHealth
- People needed
- 210
- Starts
- 2026-03-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Scheduled for elective, unilateral primary total knee arthroplasty
- Able to tolerate oral medications after surgery
You may not qualify if…
- Revision or bilateral total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification greater than 3
- Severe renal impairment (estimated glomerular filtration rate less than 15 mL/min/1.73 m²)
- Severe hepatic impairment (Child-Pugh Class C)
- Chronic opioid use of 30 morphine milligram equivalents per day or greater for more than 3 months
- Pregnancy or breastfeeding
- Seizure disorder or known hypersensitivity to suzetrigine
- Use of medications contraindicated with CYP3A metabolism
- Active gastrointestinal ulcer or bleeding
Full record on ClinicalTrials.gov
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