[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659534":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":11,"studyPopulation":11,"armGroups":99,"interventions":110,"overallOfficials":119,"centralContacts":126,"locations":136,"responsibleParty":154,"collaborators":11,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":11,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":11,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":11,"overallStatus":139,"whyStopped":11,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative opioid consumption within the first 48 hours after TKA starting from post-anesthesia care unit entry (t=0), in oral morphine equivalents (OME)",null,"From entry into the post-anesthesia care unit (PACU) to 48 hours after THA surgery",[14,17,21,25,29,33,37,41,45,49,53,57,61,65,69,73,77,81,85],{"measure":15,"description":11,"timeFrame":16},"NRS (current at rest, with ambulation, worst & least in last 24 hours) Post-Operative Day (POD) 1-14","From admission to the Post Anesthesia Care Unit (PACU) through 14 days postoperatively (Post-Op Day 14)",{"measure":18,"description":19,"timeFrame":20},"Numeric Rating Scale - post-anesthesia care unit: average, least, worst","Numeric Rating Scale in Post-Anesthesia Care Unit (PACU) ranging from average to least to worst. Post operative pain using Numeric Rating Scale(current at rest, with ambulation, worst \\& least in last 24 hours). The Numeric Rating Scale is a simple, widely used tool for measuring pain intensity. It consists of a 0-10 point scale. This will be measured after surgery in the PACU.","From arrival in PACU until discharge criteria are met (expected duration up to 2 hours postoperatively).",{"measure":22,"description":23,"timeFrame":24},"Numeric Rating Scale @Post-Operative Day14, @week 6, @week 12 - average pain, worst & least: last 7 days; current","Numeric Rating Scale measured at 14 days following surgery, then at 6 weeks following surgery and then 12 weeks following surgery. Measurements will range from average pain to worst pain to least amount of pain over the last 7 days and current pain.","From 14 days following surgery, 6 weeks from surgery and 12 weeks from surgery.",{"measure":26,"description":27,"timeFrame":28},"Cumulative Opioid consumption (Oral morphine equivalents = OME): post-anesthesia care unit, 0-24hours, 0 to 168 hours (7 days postoperatively) 0-Post-Operative Day14","Cumulative Opioid consumption (Oral morphine equivalents = OME): Post anesthesia care unit (PACU) at 0 and 24hours, 168 hours, and 14 days (i.e. 7 days postoperatively). The primary outcome is cumulative consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU). This measure will be taken from EPIC via the MAR and documented in the study \"MUD\"; post-discharge, patient to report date\u002Ftime of opioid use # of pills, dose in diary and documented in study \"MUD\". Measurements will be taken in PACU, 0-24hrs, 0-48 hrs and 0-168hrs following surgery.","from first time in PACU to 24hours after, then 168hours after, and to 14 days after",{"measure":30,"description":31,"timeFrame":32},"Opioid-free patients through Post-Operative Day2 (0-48hrs), Post-Operative Day7 (0-168hrs), Post-Operative Day14 (0-day 14)","Patients that no longer require opioid medications at Postoperative day 2 (48hrs), 7 (168hrs) and 14","From start of trial to post operative day 2, 7 and 14",{"measure":34,"description":35,"timeFrame":36},"Currently taking opioids & Opioid refills (Y\u002FN, assessed @Post-Operative Day14, @6 week, @12 week)","If patient is currently taking opioids or getting Opioid prescription refills, answered as either yes or no and assessed on post operative day 14, at week 6 and week 12 following surgery.","From surgery to post operative day 14 week 6 and week 12",{"measure":38,"description":39,"timeFrame":40},"Non-opioid analgesic use (Post-Operative Day0-48 hrs, 0-168 hrs, 0-Post-Operative Day14)","Analgesics used other than opioids on day of surgery, postoperative day 2 (i.e. 48 hrs), day 7 (i.e. 168hrs), and day 14","From day of surgery to 48hours after,168hours after, and 14 days after",{"measure":42,"description":43,"timeFrame":44},"Study medication discontinuation (% of patients who stopped the placebo\u002FSuzetrigine day 0 through post-op day 14)","The percentage of patients who patients who stopped taking either the placebo drug or Suzetrigine within the first 14 days following surgery","From surgery to the 14th day post operatively",{"measure":46,"description":47,"timeFrame":48},"Request for Suzetrigine refill after randomization period","Number of patients that requested more or a refill of Suzetrigine after the randomization period was over","From date if surgery till until end of study up to 2 years after surgery",{"measure":50,"description":51,"timeFrame":52},"Patient satisfaction with pain management: @ Post-Operative Day2 and @Post-Operative Day7 and @Post-Operative Day14","Patients will communicate there satisfaction with how well their pain is controlled this will be assessed 2 days and 7 days and 14 days following surgery. Number on Scale out of 10 (where 0 is not satisfied, 10 is very satisfied).","From date of surgery to 2 days following surgery and then again 7 days following surgery and 14 days following surgery.",{"measure":54,"description":55,"timeFrame":56},"Pain Interference: @Post-Operative Day2 and @ Post-Operative Day7 and @Post-Operative Day14","Measuring how much since surgery Pain has interfered with normal day to day activities. This will be self reported using a number Scale (0-10, 0= no interference, 10= significant interference) on postoperative days 2 and 7 and 14. Patients will be asked; how much, since your surgery, has pain interfered with performing activities in bed such as turning, sitting up, and changing position? how much, since your surgery, has pain interfered with walking? how much, since your surgery, has pain interfered with your sleep? how much, since your surgery, has pain interfered with your mood?","From date of surgery to post operative day 2 and 7 and 14",{"measure":58,"description":59,"timeFrame":60},"KOOS, JR @ 6 weeks","Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a 0-100 scale that assesses hip pain and function, where a higher score indicates better hip health and a lower score indicates greater disability. This will be assessed preoperatively within 30 days of the surgery and then again 6 weeks post operatively. This measure will be extracted via EPIC or by a patient reported survey if not filled out in EPIC\u002Fmychart.","Up to 30 days preoperatively to 6 weeks following surgery",{"measure":62,"description":63,"timeFrame":64},"Sleep quality & @preop, Post-Operative Day7 and Post-Operative Day14 (questionnaire asks about sleep quality\u002Fduration over the past week)","Sleep quality will be assessed using patient-reported questionnaires that evaluate sleep patterns over the preceding week. Assessments will be completed preoperatively and on postoperative days 7 and 14. Outcomes will include overall sleep quality rating and average sleep duration in hours per night.","Pre-op and Post-Operative Day (POD)7 and Post-Operative Day (POD)14",{"measure":66,"description":67,"timeFrame":68},"Incidence of adverse invents (Post-Operative Day0-14)","Unexpected adverse events, that may occur to the patient after administration of Suzetrigine from the date the medication is given to the 14th day following surgery using Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0) grading system\n\nGrade 1 Mild; Grade 2 Moderate; Grade 3 Severe or medically significant; Grade 4 Life-threatening consequences; Grade 5 Death related to AE.\n\nfor Nausea, Vomiting, Constipation, Difficulty passing urine, Concentrating, Somnolence, Lightheaded\u002Fdizziness, Confusion, Fatigue, Pruritis, Headache, Dry mouth, Paresthesia, Muscle spasm, Rashes, Problems with sleep, Delirium, Abnormal lab values, Other Patient-reported adverse effects (diarrhea, changes to heart beat\u002Farrythmias, blurred vision, low blood pressure, difficulty breathing, hives, swelling of the face\u002Flips\u002Ftongue\u002Fextremities\u002Fthroat, other)","From the date the medication is given to the post operative day 14.",{"measure":70,"description":71,"timeFrame":72},"Patient expectation of Suzetrigine @preop","Patient expectations regarding the effectiveness of Suzetrigine for postoperative pain management will be assessed prior to surgery using a questionnaire. Patients will report their anticipated level of pain relief, improvement in function, reduction in opioid requirements, and overall confidence in the medication.","Pre-op",{"measure":74,"description":75,"timeFrame":76},"Block duration assessed @Post-Operative Day1, (or Post-Operative Day2 or until full resolution)","Duration of peripheral nerve block will be assessed from the time of block administration until complete resolution of sensory and motor blockade. Resolution will be determined through patient report and clinical assessment of return of normal sensation and motor function.","Postoperative day 1 or until complete resolution of sensory and motor blockade assessed for up to 14 days postoperatively",{"measure":78,"description":79,"timeFrame":80},"Range of Motion (ROM) @week 6","Knee range of motion (ROM) will be measured at 6 weeks following surgery using standard clinical assessment techniques. ROM will be recorded in degrees and include measurements of both knee flexion and extension. Higher flexion and lower extension deficits indicate improved postoperative joint function.","6 weeks post operative",{"measure":82,"description":83,"timeFrame":84},"Rate of manipulation under anesthesia (MUA) through 6 weeks and through 12 weeks","The rate of manipulation under anesthesia (MUA) performed for postoperative knee stiffness will be recorded through 6 weeks and 12 weeks after surgery. Incidence will be reported as the proportion of patients requiring MUA during the follow-up period.","Day of surgery to 12 weeks post-surgery",{"measure":86,"description":87,"timeFrame":88},"duration @preop, Post-Operative Day7 and Post-Operative Day14 (questionnaire asks about sleep quality\u002Fduration over the past week)","Sleep duration will be assessed using patient-reported questionnaires that evaluate sleep patterns over the preceding week. Assessments will be completed preoperatively and on postoperative days 7 and 14. Outcomes will include overall sleep quality rating and average sleep duration in hours per night.","Preop, Post-Operative Day (POD)7 and Post-Operative Day (POD) 14",{"allocation":90,"interventionModel":91,"interventionModelDescription":11,"primaryPurpose":92,"observationalModel":11,"timePerspective":11,"maskingInfo":93},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":94,"maskingDescription":11,"whoMasked":95},"TRIPLE",[96,97,98],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[100,105],{"label":101,"type":102,"description":11,"interventionNames":103},"Placebo arm","PLACEBO_COMPARATOR",[104],"Other: Placebo",{"label":106,"type":107,"description":11,"interventionNames":108},"Suzetrigine","EXPERIMENTAL",[109],"Drug: Suzetrigine",[111,115],{"type":6,"name":112,"description":113,"armGroupLabels":114,"otherNames":11},"Placebo","This will be a placebo drug.",[101],{"type":116,"name":106,"description":117,"armGroupLabels":118,"otherNames":11},"DRUG","Suzetrigine is a new novel peripherally acting non-opioid pain medication recently approved by the FDA that exerts its analgesic effects by binding to the peripherally located Nav1.8 Sodium channel receptors present on peripheral nerves.",[106],[120,124],{"name":121,"affiliation":122,"role":123},"Meghan Kirskey, MD","Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery","PRINCIPAL_INVESTIGATOR",{"name":125,"affiliation":122,"role":123},"Alexandra Sideris, PhD",[127,132],{"name":128,"role":129,"phone":130,"phoneExt":11,"email":131},"Curtis Weh, B.S.","CONTACT","917-260-3937","wehc@hss.edu",{"name":133,"role":129,"phone":134,"phoneExt":11,"email":135},"Hannah Gerner, MD","646-714-6509","Gernerha@hss.edu",[137],{"facility":138,"status":139,"city":140,"state":140,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":149,"contacts":150},"Hospital for Special Surgery","RECRUITING","New York","10021","United States","US",{"type":145,"coordinates":146},"Point",[147,148],-74.00597,40.71427,{"lat":148,"lon":147},[151],{"name":125,"role":129,"phone":152,"phoneExt":11,"email":153},"212-774-2602","siderisa@hss.edu",{"type":155,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659534","phase-3-suzetrigine-in-tka-100659534",false,"NCT07864896","Suzetrigine in TKA","A Randomized, Double-Blind, Placebo-Controlled Trial of Suzetrigine in Total Knee Arthroplasty","Inclusion Criteria:\n\n* Patients undergoing primary TKA with participating surgeons\n* Age 18 to 80 years old\n* Planned Discharge to home\n* Planned use of neuraxial anesthesia\n* American Society of Anesthesiologist (ASA) Physical Status 1 - 3\n* Patients undergoing primary unilateral TKA with participating surgeons\n\nExclusion Criteria:\n\n* ASA greater than 3\n* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)\n* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)\n* History of QT prolongation\n* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device\n* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse\n* Inability to comply with any component of the study protocol\n* Younger than 18 or greater than 80 years old at the time of enrollment\n* Patient already on Suzetrigine\n* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease\u002FChild Pugh B or C, use of strong CYP3 inhibitors or inducers)\n* Contraindications to neuraxial anesthesia or any other part of the study protocol\n* Participation in another investigational drug or device study\n* Pregnancy\n* Prior osteotomy of the operative knee\n* Baseline knee flexion \\\u003C60°\n* History of infection or septic arthritis of the operative knee",true,"ALL","18 Years","80 Years",{"count":168,"type":169},148,"ESTIMATED","INTERVENTIONAL",[172],"PHASE3","Total knee replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of suzetrigine's efficacy in total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 days), with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).",[175,176,177,178,179,180,106,181,182,183,184,185,186,187,188,189,190],"Total Knee Arthroplasty (TKA)","Total Knee Arthroplasty \\(TKA\\)","Total Knee Replacement","Total Knee Replacement Surgery","Total Knee Replacements","Total Knee Replacement Arthroplasty","Pain Management","Pain","Nav 1.8","JOURNAVX","Opioid Cessation","Opioid Consumption, Postoperative","Multimodal Analgesia","Randomized Controlled Trial","Randomized Controlled Study","Randomized Controlled Trials","2026-10-07",{"date":193,"type":194},"2026-10-08","ACTUAL",{"date":191,"type":194},{"date":197,"type":169},"2030-01",{"name":5,"class":6},1]