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

August 31, 2026 updated by: Ravi Bashyal, Endeavor Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Endeavor Health, Skokie Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Suzetrigine and standard care pain medicines
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
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
Drug: Opioid standard care pain medicine
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.
Active Comparator: Standard care pain medicines
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain score (Numeric Rating Scale - NRS)
Time Frame: Day 0-14 post-operatively and day 30
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption (MME)
Time Frame: Day 0-14 post-operatively and day 30
Cumulative opioid consumption will be calculated and expressed as morphine milligram equivalents (MME) using a standard opioid conversion table.
Day 0-14 post-operatively and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endeavor Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2026-0056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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