Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndeavor Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Suzetrigine
Drug100mg 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
DrugOpioid 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Suzetrigine and standard care pain medicinesExperimental treatment 2 interventions
Group B: Standard care pain medicinesActive comparator 1 intervention
Trial outcomes
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.
Time frame
Day 0-14 post-operatively and day 30Secondary outcomes
1
Cumulative opioid consumption (MME)
Cumulative opioid consumption will be calculated and expressed as morphine milligram equivalents (MME) using a standard opioid conversion table.
Time frame
Day 0-14 post-operatively and day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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