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NCT07796152
Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery
Conditions: Knee Arthroplasty, Total, Post Operative Pain, Acute, Opioid Consumption, Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: Endeavor Health
Location: Endeavor Health, Skokie Hospital Skokie Illinois
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.
Eligibility Criteria
Inclusion Criteria:
* outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07796152). StuddyBuddy aggregates publicly available trial information.