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Evaluating Suzetrigine for Pain Control Following TKA

NCT07357376 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-01-22

No results posted yet for this study

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

Conditions

  • Postoperative Pain Following Knee Arthroplasty

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • American Association of Hip and Knee Surgeons

    collaborator OTHER

  • AdventHealth

    lead OTHER

Principal Investigators

  • Ramakanth Yakkanti, MD · Rothman Orthopaedics Florida at AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-07-01
Completion
2026-08-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357376 on ClinicalTrials.gov