Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery
Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
We will be conducting a prospective, randomized, matched cohort study. This is an open-label study. We plan to enroll 100 patients undergoing outpatient total knee arthroplasty (TKA) at Endeavor Health with orthopaedic surgeon Dr. Bashyal.
Subjects 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, subjects 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 patients and explain the study in more detail over the phone and answer any questions the patient may have. Patients who are still interested in participating will be sent an electronic consent using a dedicated RedCap database that will also be used for patient data collection. Patients will be given time to review the consent and then asked to complete the consent form online should they wish to participate.
Enrolled patients will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician.
Patients 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.
Patients 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. Patients who miss surveys will be called by the research team and the information will be collected at that time.
Patient 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
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Shanah Salter, MBBS CCRP
- Phone Number: 847-570-1572
- Email: ortho_research@endeavorhealth.org
Study Locations
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Illinois
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Skokie, Illinois, United States, 60076
- Endeavor Health, Skokie Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
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100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days in addition to standard care pain medicines for post-operative total knee arthroplasty pain
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score (NRS)
Time Frame: Day 0-14 post-operatively and day 30
|
Post-operative pain score measured using the Numeric Rating Scale (NRS) system
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Day 0-14 post-operatively and day 30
|
Secondary Outcome Measures
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.
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Day 0-14 post-operatively and day 30
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2026-0056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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