[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654194":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":38,"overallOfficials":17,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":17,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":17,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":17,"enrollmentInfo":81,"targetDuration":17,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":97,"whyStopped":17,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Endeavor Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Day 0-14 post-operatively and day 30",[14],{"measure":15,"description":16,"timeFrame":12},"Cumulative opioid consumption (MME)","Cumulative opioid consumption will be calculated and expressed as morphine milligram equivalents (MME) using a standard opioid conversion table.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","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.\n\nParticipants will be introduced to the study during their pre-operative surgical visit and\u002For 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.\n\nResearch 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.\n\nEnrolled participants will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician.\n\nParticipants will be notified of their treatment allocation prior to surgery and will be instructed to collect their filled suzetrigine and\u002For opioid prescription from Skokie Hospital outpatient pharmacy.\n\nParticipants 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.\n\nParticipant 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.",[26,33],{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31,32],"Drug: Suzetrigine","Drug: Opioid standard care pain medicine",{"label":34,"type":35,"description":36,"interventionNames":37},"Standard care pain medicines","ACTIVE_COMPARATOR","Standard care pain medicines prescribed for an outpatient total knee arthroplasty typically include an opioid such as hydrocodone\u002Facetaminophen (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.",[32],[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":17},"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",[27],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":17},"Opioid standard care pain medicine","Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone\u002Facetaminophen (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.",[34,27],[49],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},"Shanah Salter, MBBS CCRP","CONTACT","847-570-1572","ortho_research@endeavorhealth.org",[55],{"facility":56,"status":17,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":17},"Endeavor Health, Skokie Hospital","Skokie","Illinois","60076","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-87.73339,42.03336,{"lat":66,"lon":65},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Ravi Bashyal","Orthopaedic Surgeon","100654194","phase-4-suzetrigine-vs-standard-care-pain-relief-following-outpatient-knee-replacement-surgery-100654194",false,"NCT07796152","Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery","Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study","Inclusion Criteria:\n\n* outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal\n\nExclusion Criteria:\n\n* Allergy to suzetrigine or any of its ingredients\n* Contraindication to suzetrigine (eg moderate to severe hepatic impairment, severe renal impairment)\n* Previous or current suzetrigine prescription\n* Use of a concomitant medication that is a strong CYP3A inhibitor\n* Patients unwilling to discontinue use of grapefruit or food and drink containing grapefruit while taking suzetrigine\n* Pregnant or lactating women\n* 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\n* Pre-operative peripheral nerve stimulation (PNS) system in place\n* Age \\\u003C 18\n* Dementia or other mental issue that would interfere with accurate pain and medication reporting\n* Those unable to consent in English","ALL","18 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","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.",[89,90,91],"Knee Arthroplasty, Total","Post Operative Pain, Acute","Opioid Consumption, Postoperative",[93,94,95,96],"suzetrigine","knee replacement","opioid","post-operative pain","NOT_YET_RECRUITING","2026-08-31",{"date":100,"type":101},"2026-09-02","ACTUAL",{"date":103,"type":83},"2026-09",{"date":105,"type":83},"2028-01",{"name":5,"class":6},1]