Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery

NCT07796152 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB2026-0056
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if a person having an outpatient total knee replacement will have a difference in their pain and the amount of pain medication (opioids) used after discharge if they are given suzetrigine (a non-opioid pain medicine, also known as Journavx®) in addition to the standard pain medicines usually prescribed. Participants will complete a daily pain and medication diary and survey for up to 14 days post-operatively and on day 30.

Conditions

Knee Arthroplasty, Total; Post Operative Pain, Acute; Opioid Consumption, Postoperative

Keywords

suzetrigine; knee replacement; opioid; post-operative pain

Outcome Measures

Primary Outcomes (1)

• Pain score (Numeric Rating Scale - NRS)

  The Numeric Rating Scale (NRS) system is used to measure pain. It is a simple 11-point scale from 0 to 10 for quantifying subjective pain intensity. O means "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain" where 10 is the worst pain imaginable.

  Day 0-14 post-operatively and day 30

Secondary Outcomes (1)

• Cumulative opioid consumption (MME)

  Day 0-14 post-operatively and day 30

Study Arms (2)

Suzetrigine and standard care pain medicines

EXPERIMENTAL

In addition to the standard care pain medicines prescribed for an outpatient total knee arthroplasty, this group will receive a 100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days.

Drug: Suzetrigine; Drug: Opioid standard care pain medicine

Standard care pain medicines

ACTIVE COMPARATOR

Standard care pain medicines prescribed for an outpatient total knee arthroplasty typically include an opioid such as hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol (Ultram) for as needed post-operative pain relief. The exact opioid and dose prescribed will be up to the discretion of the surgeon and based on what is most appropriate for an individual patient.

Drug: Opioid standard care pain medicine

Interventions

Suzetrigine DRUG

100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days for post-operative total knee arthroplasty pain

Suzetrigine and standard care pain medicines

Opioid standard care pain medicine DRUG

Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol (Ultram) for as needed post-operative pain relief. The exact opioid and dose prescribed will be up to the discretion of the surgeon and based on what is most appropriate for an individual patient.

Standard care pain medicines; Suzetrigine and standard care pain medicines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal

You may not qualify if:

• Allergy to suzetrigine or any of its ingredients
• Contraindication to suzetrigine (eg moderate to severe hepatic impairment, severe renal impairment)
• Previous or current suzetrigine prescription
• Use of a concomitant medication that is a strong CYP3A inhibitor
• Patients unwilling to discontinue use of grapefruit or food and drink containing grapefruit while taking suzetrigine
• Pregnant or lactating women
• Women taking hormonal contraceptives containing progestins other than levonorgestrel and norethindrone must agree to use barrier contraception (eg condoms) or abstain from intercourse during the study or will be excluded from the study for safety reasons
• Pre-operative peripheral nerve stimulation (PNS) system in place
• Age \< 18
• Dementia or other mental issue that would interfere with accurate pain and medication reporting
• Those unable to consent in English

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health, Skokie Hospital

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Shanah Salter, MBBS CCRP

CONTACT

847-570-1572; ortho_research@endeavorhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)