What this study is
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.
What's being tested
- Suzetrigine
Intervention · 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
- Opioid standard care pain medicine
Intervention · 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.
Study details
- Official title
- Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
- Sponsor
- Endeavor Health
- Conditions
- Knee Arthroplasty, Total · Post Operative Pain, Acute · Opioid Consumption, Postoperative
- Enrolling
- 100 people
- Starts
- 2026-09
- Est. completion
- 2028-01
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openEndeavor Health, Skokie Hospital
Skokie, Illinois, United States
Study team
Sponsor
Endeavor Health
Study ID IRB2026-0056
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.