[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641229":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":51,"responsibleParty":65,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":27,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":27,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":99,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Suzetrigine-Based Regimen","EXPERIMENTAL","Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.",[13,14],"Drug: Suzetrigine","Drug: Scheduled Acetaminophen and Ibuprofen",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Opioid-Inclusive Analgesic Regimen","ACTIVE_COMPARATOR","Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.",[20,14],"Drug: Opioid Analgesics (Tramadol or Oxycodone)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Suzetrigine","Loading dose: 100 mg orally on the morning of surgery\n\nMaintenance dose: 50 mg orally every 12 hours for 7 days\n\nCo-administered medications: Scheduled acetaminophen and ibuprofen\n\nMechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons\n\nPurpose: Opioid-sparing postoperative analgesia",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Opioid Analgesics (Tramadol or Oxycodone)","Tramadol: 50 mg orally every 4-6 hours as needed OR\n\nOxycodone: 5 mg orally every 4-6 hours as needed\n\nCo-administered medications: Scheduled acetaminophen and ibuprofen\n\nPurpose: Standard postoperative analgesia per institutional protocol",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Scheduled Acetaminophen and Ibuprofen","Participants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery.",[16,9],[37],{"name":38,"affiliation":5,"role":39},"A Lenore Ackeman, MD, PhD","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"A Lenore Ackerman, MD, PhD","CONTACT","310-794-0206","aackerman@mednet.ucla.edu",{"name":47,"role":43,"phone":48,"phoneExt":49,"email":50},"Cindy Gu, MD","310-794-7700","35879","cgu@mednet.ucla.edu",[52],{"facility":53,"status":27,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":27},"University of California, Los Angeles (UCLA)","Los Angeles","California","90095","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-118.24368,34.05223,{"lat":63,"lon":62},{"type":39,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Anne Lenore Ackerman","Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA","100641229","phase-4-suzetrigine-for-opioid-sparing-postoperative-analgesia-following-transvaginal-pelvic-reconstructive-surgery-100641229",false,"NCT07600697","Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Chronic opioid use.\n* Liver failure.\n* End-stage renal disease (ESRD).\n* Chronic pain syndromes, including:\n\nFibromyalgia Interstitial cystitis Chronic pelvic pain\n\n* Contraindication to acetaminophen or ibuprofen.\n* Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.","FEMALE","18 Years",{"count":77,"type":78},120,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.",[84,85,86],"Pelvic Organ Prolapse (POP)","Stress Urinary Incontinence (SUI)","Postoperative Pain",[24,88,89,90,91,92,93,94,95,96,97,98],"NaV1.8 Inhibitor","Non-opioid analgesic","pelvic reconstructive surgery","transvaginal surgery","postoperative pain","opioid-sparing analgesia","multimodal pain management","pelvic organ prolapse","randomized clinical trial","stepped-wedge design","phase 4 trial","NOT_YET_RECRUITING","2026-05-29",{"date":102,"type":103},"2026-06-02","ACTUAL",{"date":105,"type":78},"2026-07-01",{"date":107,"type":78},"2028-07-01",{"name":5,"class":6},1]