Knee Arthroplasty, TotalPhase 4NCT07796152
Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery
A Phase 4 study testing Suzetrigine in people with Knee Arthroplasty, Total and Post Operative Pain, Acute, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Post Operative Pain, Acute, Opioid Consumption, Postoperative
- What is being tested?
- Suzetrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Endeavor Health, Skokie Hospital
Skokie, Illinois, 60076
About this study
Official title: Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
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.
Read the detailed description
The investigators will be conducting a prospective, randomized, matched cohort study. This is an open-label study. 100 participants undergoing outpatient total knee arthroplasty (TKA) at Endeavor Health with orthopaedic surgeon Dr. Bashyal will be enrolled.
Participants will be introduced to the study during their pre-operative surgical visit and/or will receive a surgeon-signed information letter about the study in their pre-operative TKA take-home information packet. With approval from the surgeon, participants may also (or instead) be sent a signed recruitment letter via the Endeavor Health messaging system by the research team.
Research staff will call eligible participants and explain the study in more detail over the phone and answer any questions. Eligible participants who are still interested in participating will be sent an electronic consent using a dedicated RedCap database that will also be used for participant data collection. Eligible participants will be given time to review the consent and then asked to complete the consent form online should they wish to participate.
Enrolled participants will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician.
Participants will be notified of their treatment allocation prior to surgery and will be instructed to collect their filled suzetrigine and/or opioid prescription from Skokie Hospital outpatient pharmacy.
Participants will be provided with a pain medication diary to help track their pain score and medications throughout the day. They will then enter their diary responses into REDCap pain and medication surveys sent via email. Participants who miss surveys will be called by the research team and the information will be collected at that time.
Participant involvement will cease at day 30 post-operatively and any further information (for data up until 90 days postoperatively) will be taken from the medical record.
- Being tested
- Suzetrigine, Opioid standard care pain medicine
- Keywords
- suzetrigine, knee replacement, opioid, post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
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 medicineDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Opioid standard care pain medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0-14 post-operatively and day 30
Secondary 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.
Measured: Day 0-14 post-operatively and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Bashyal, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796152
- Sponsor's protocol ID
- IRB2026-0056
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No