[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620419":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":11,"responsibleParty":38,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":11},{"fullName":5,"class":6},"AdventHealth","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suzetrigine\u002FJournavx","EXPERIMENTAL",null,[13],"Drug: Suzetrigine",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Suzetrigine","Suzetrigine is an oral, non-opioid pain medication that works by blocking specific sodium channels involved in pain signaling. In this study, participants assigned to the suzetrigine group will receive a 100 milligram oral dose in the preoperative area, immediately prior to undergoing the procedure, followed by 50 milligrams taken by mouth twice daily for 14 days after surgery. Suzetrigine will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"The placebo is an oral tablet designed to look like the suzetrigine tablet but contains no active drug. In this study, participants assigned to the placebo group will receive a tablet in the preoperative area immediately prior to the procedure, followed by placebo tablets taken by mouth twice daily for 14 days after surgery. The placebo will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.",[15],[29],{"name":30,"affiliation":31,"role":32},"Ramakanth Yakkanti, MD","Rothman Orthopaedics Florida at AdventHealth","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","844-407-4070","ramakanth.yakkanti@rothmanortho.com",{"type":32,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Teja Yeramosu","Resident Physician",[42],{"name":43,"class":6},"American Association of Hip and Knee Surgeons","100620419","phase-3-evaluating-suzetrigine-for-pain-control-following-tka-100620419",false,"NCT07357376","Evaluating Suzetrigine for Pain Control Following TKA","Evaluating a Non-Opioid Analgesic Strategy for Enhanced Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial of Suzetrigine","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective, unilateral primary total knee arthroplasty\n* Able to tolerate oral medications after surgery\n\nExclusion Criteria:\n\n* Revision or bilateral total knee arthroplasty\n* American Society of Anesthesiologists (ASA) physical status classification greater than 3\n* Severe renal impairment (estimated glomerular filtration rate less than 15 mL\u002Fmin\u002F1.73 m²)\n* Severe hepatic impairment (Child-Pugh Class C)\n* Chronic opioid use of 30 morphine milligram equivalents per day or greater for more than 3 months\n* Pregnancy or breastfeeding\n* Seizure disorder or known hypersensitivity to suzetrigine\n* Use of medications contraindicated with CYP3A metabolism\n* Active gastrointestinal ulcer or bleeding","ALL","18 Years",{"count":54,"type":55},210,"ESTIMATED","INTERVENTIONAL",[58],"PHASE3","The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. The main questions it aims to answer are:\n\nDoes suzetrigine lower the amount of opioid pain medicine participants use after surgery?\n\nDoes suzetrigine have any effect on postoperative patient-reported outcomes, including pain scores, range of motion, length of stay, and KOOS\u002FPROMIS surveys?\n\nResearchers will compare suzetrigine to a placebo to see if suzetrigine works to treat pain after total knee replacement surgery.\n\nParticipants will:\n\nTake suzetrigine or a placebo by mouth for 14 days after surgery\n\nReceive standard pain care, including opioid pain medicine only if needed\n\nReport their pain levels using short daily surveys\n\nAttend routine follow-up visits after surgery",[61],"Postoperative Pain Following Knee Arthroplasty",[63,64,65,22,66,67],"Total Knee Arthroplasty","Postoperative Pain","Journavx","Opioid","Enhanced Recovery","NOT_YET_RECRUITING","2026-01-20",{"date":71,"type":72},"2026-01-22","ACTUAL",{"date":74,"type":55},"2026-03-01",{"date":76,"type":55},"2026-08-01",{"name":5,"class":6}]