[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656836":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":49,"studyPopulation":40,"armGroups":50,"interventions":57,"overallOfficials":66,"centralContacts":70,"locations":40,"responsibleParty":75,"collaborators":40,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":40,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":40,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":40,"overallStatus":97,"whyStopped":40,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":40},{"fullName":5,"class":6},"Ohio State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Total Opioid Consumption During the First 48 Hours After Surgery","Total inpatient opioid consumption, expressed as morphine milligram equivalents (MME), during the first 48 hours following surgery. Opioid use among participants receiving suzetrigine will be compared with matched historical controls receiving standard multimodal analgesia.","48 hours postoperatively",[14,18,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"Daily Total Opioid Consumption","Daily opioid consumption, expressed as MME, during hospitalization.","Postoperative Days 1-7 (up to hospital discharge)",{"measure":19,"description":20,"timeFrame":17},"Daily Intravenous Opioid Consumption","Daily intravenous opioid use, expressed as MME, during hospitalization.",{"measure":22,"description":23,"timeFrame":24},"Postoperative Pain Burden","Time-weighted area under the curve (AUC) of postoperative pain intensity based on routinely collected pain scores.","24 and 48 hours postoperatively",{"measure":26,"description":27,"timeFrame":28},"Time to First Opioid Rescue Medication","Time from initial suzetrigine administration to first rescue opioid administration","Up to hospital discharge (average 3-7 days)",{"measure":30,"description":31,"timeFrame":32},"Incidence of Opioid-Related Adverse Events","Occurrence of opioid-related adverse events including nausea and vomiting, constipation, urinary retention, respiratory depression, sedation, delirium, and pruritus","Day 14 (±7 days) after surgery",{"measure":34,"description":35,"timeFrame":36},"Time to First Ambulation","Time from surgery to first ambulation of at least three steps with an assistive device.","At first ambulation, up to hospital discharge (average 3-7 days)",{"measure":38,"description":39,"timeFrame":32},"Discharge Opioid Utilization","Total opioid consumption and opioid prescribing during the 14-day postoperative treatment period.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"NA","SINGLE_GROUP","Single-arm prospective interventional study in which all enrolled participants receive suzetrigine in addition to standard multimodal analgesia. Outcomes will be compared with a matched historical control cohort derived from institutional data.","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":40},"NONE","This is an open-label study. All prospective participants receive suzetrigine in addition to standard multimodal analgesia. Participants, care providers, investigators, and outcome assessors are aware of treatment assignment. Study outcomes are compared with matched historical controls.","Postoperative pain management following spine surgery remains a significant clinical challenge. Patients undergoing lumbar decompression, fusion, and other major spine procedures frequently experience substantial postoperative pain, require high doses of opioid analgesics, and are at increased risk for opioid-related adverse events, including postoperative nausea and vomiting, ileus, urinary retention, oversedation, respiratory depression, delirium, and delayed mobilization. Although multimodal analgesia strategies are widely implemented, the use of nonsteroidal anti-inflammatory drugs may be limited in fusion procedures because of concerns regarding bone healing, and regional anesthesia techniques are not universally applicable. Consequently, opioids remain a primary component of perioperative pain management in many spine surgery patients.\n\nSuzetrigine (Journavx) is a first-in-class, selective NaV1.8 inhibitor that provides analgesia through peripheral inhibition of pain signaling without the central nervous system effects associated with opioids. Clinical studies in acute postoperative pain have demonstrated effective analgesia, reduced reliance on rescue medication, and a favorable safety profile. Given the high opioid requirements and substantial burden of opioid-related complications in spine surgery, this population represents an important setting in which to evaluate the potential opioid-sparing effects of suzetrigine.\n\nThis prospective, single-center study will evaluate postoperative outcomes among patients undergoing spine surgery who receive suzetrigine as part of perioperative pain management. Outcomes will be compared with matched historical controls treated with standard multimodal analgesia. The primary objective is to estimate the magnitude of opioid reduction during the first 48 hours after surgery. Secondary objectives include evaluation of inpatient and post-discharge opioid utilization, postoperative pain scores, opioid-related adverse events, hospital length of stay, discharge disposition, readmissions, and healthcare resource utilization.\n\nIn addition to assessing clinical outcomes, the study is intended to characterize variability in treatment response across patient and procedural subgroups and to identify the most informative efficacy, safety, clinical, and economic endpoints for future investigation. Findings from this study will generate real-world evidence regarding the use of suzetrigine in spine surgery and will inform the design, endpoint selection, and sample size considerations for a future multicenter randomized clinical trial.",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"Suzetrigine Plus Standard Multimodal Analgesia","EXPERIMENTAL","Participants undergoing elective posterior lumbar fusion surgery will receive suzetrigine (Journavx) in addition to standard multimodal analgesia. Suzetrigine will be administered as a 100 mg oral loading dose within 2 hours prior to surgery, followed by 50 mg orally every 12 hours for 14 days. Participants will also receive standard perioperative pain management according to the institutional Enhanced Surgical Recovery (ESR) spine surgery pathway, including acetaminophen, muscle relaxants, and opioid analgesics as clinically indicated. Outcomes will be compared with matched historical controls receiving standard multimodal analgesia without suzetrigine.",[56],"Drug: Suzetrigine (Journavx)",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Suzetrigine (Journavx)","Suzetrigine administered as a 100 mg oral loading dose preoperatively followed by 50 mg orally every 12 hours for 14 days.",[52],[64,65],"Journavx","VX-548",[67],{"name":68,"affiliation":5,"role":69},"Bryan Ladd, MD","PRINCIPAL_INVESTIGATOR",[71],{"name":68,"role":72,"phone":73,"phoneExt":40,"email":74},"CONTACT","614-688-9440","Bryan.Ladd@osumc.edu",{"type":76,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100656836","phase-4-suzetrigine-journavx-for-pain-management-after-spine-surgery-100656836",false,"NCT07829718","Suzetrigine (Journavx) for Pain Management After Spine Surgery","Prospective Evaluation of Suzetrigine (Journavx) in Spine Surgery: Signal Characterization and Trial-Design Optimization Using Historical Controls","Inclusion Criteria:\n\n* Adults aged 18 to 80 years. Scheduled to undergo elective posterior-only lumbar fusion involving 1 to 3 spinal levels.\n\nAnticipated postoperative inpatient admission. Eligible for the institutional Enhanced Surgical Recovery (ESR) spine surgery pathway.\n\nAble and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Known contraindication or hypersensitivity to suzetrigine. Chronic or daily opioid use prior to surgery. Clinically significant hepatic or renal dysfunction. Inability or unwillingness to comply with study procedures or follow-up assessments.\n\nPrisoner at the time of surgery or hospitalization. Known pregnancy at the time of surgery.","ALL","18 Years","80 Years",{"count":88,"type":89},110,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","This prospective, single-center interventional study will evaluate the effect of suzetrigine (Journavx), a selective NaV1.8 inhibitor, on postoperative opioid requirements in patients undergoing spine surgery. Participants receiving suzetrigine as part of standard perioperative care will be compared with matched historical controls treated with standard multimodal analgesia. The study aims to characterize the magnitude and variability of opioid-sparing effects during the immediate postoperative period, with primary assessment focused on inpatient opioid consumption during the first 48 hours after surgery.\n\nSecondary objectives include evaluation of postoperative pain scores, opioid-related adverse events, hospital length of stay, discharge disposition, post-discharge opioid prescribing patterns, and healthcare utilization. Findings from this study will provide real-world evidence regarding the potential role of suzetrigine in spine surgery and will inform the design and endpoint selection of a future multicenter randomized clinical trial.",[95,96],"Spine Fusion","Postoperative Pain","NOT_YET_RECRUITING","2026-09-18",{"date":100,"type":101},"2026-09-21","ACTUAL",{"date":103,"type":89},"2026-09-13",{"date":105,"type":89},"2030-12-30",{"name":5,"class":6}]