Evaluating Suzetrigine for Pain Control Following TKA
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
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
Eligibility criteria
Qualifiers
Age 18 years or older
Scheduled for elective, unilateral primary total knee arthroplasty
Able to tolerate oral medications after surgery
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Suzetrigine
- Placebo
Treatment groups
210 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
AdventHealth
Lead sponsor
American Association of Hip and Knee Surgeons
Collaborator
Source ClinicalTrials.gov