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Evaluating Suzetrigine for Pain Control Following TKA
Sponsor: AdventHealth
Summary
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
Official title: Evaluating a Non-Opioid Analgesic Strategy for Enhanced Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial of Suzetrigine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2026-03-01
Completion Date
2026-08-01
Last Updated
2026-01-22
Healthy Volunteers
No
Interventions
Suzetrigine
Suzetrigine is an oral, non-opioid pain medication that works by blocking specific sodium channels involved in pain signaling. In this study, participants assigned to the suzetrigine group will receive a 100 milligram oral dose in the preoperative area, immediately prior to undergoing the procedure, followed by 50 milligrams taken by mouth twice daily for 14 days after surgery. Suzetrigine will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.
Placebo
The placebo is an oral tablet designed to look like the suzetrigine tablet but contains no active drug. In this study, participants assigned to the placebo group will receive a tablet in the preoperative area immediately prior to the procedure, followed by placebo tablets taken by mouth twice daily for 14 days after surgery. The placebo will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.