[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657356":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":48,"studyPopulation":44,"armGroups":49,"interventions":60,"overallOfficials":68,"centralContacts":44,"locations":44,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":44,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":44,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":100,"whyStopped":44,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":44},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery","Number of participants needing any opioids","Up to 7 days after PACU discharge following surgery",[14,17,20,24,28,31],{"measure":15,"description":16,"timeFrame":12},"Total post-surgical opioid consumption after PACU discharge following surgery","Total opioid consumption in mg",{"measure":18,"description":19,"timeFrame":12},"Average pain score in the first week following PACU discharge after surgery","Average verbal rating pain score",{"measure":21,"description":22,"timeFrame":23},"Pain score on day 7","Verbal rating pain score (0=no pain, 10= worst possible pain)","Day 7 after surgery",{"measure":25,"description":26,"timeFrame":27},"Duration of PACU stay","Minutes of stay in PACU","PACU stay, up to approximately 3 hours",{"measure":29,"description":30,"timeFrame":27},"Need for opioids in PACU","Number of participants needing any opioids in PACU",{"measure":32,"description":33,"timeFrame":27},"Opioid consumption in PACU","Total opioid consumption in mg morphine equivalents",[35,38],{"measure":36,"description":37,"timeFrame":12},"Opioid related side effects in the suzetrigine group","Number of participants with nausea, vomiting, itching, constipation and ileus",{"measure":39,"description":40,"timeFrame":23},"Proportion of participants reporting good, very good, or excellent on a Patient Global Assessment (PGA) for pain control at 7 days after surgery.","Number of patients reporting good, very good, or excellent on a Patient Global Assessment (PGA) for pain control at 7 days after surgery (scale includes the following responses: poor, fair, good, very good, excellent).",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":44,"timePerspective":44,"maskingInfo":46},"NON_RANDOMIZED","SINGLE_GROUP",null,"TREATMENT",{"masking":47,"maskingDescription":44,"whoMasked":44},"NONE","This will be a matched cohort study with a prospective and a retrospective component. Women undergoing laparoscopic\u002Frobotic hysterectomy with our ERAS protocol will be approached to participate in the prospective open label component of the study. In the preoperative holding area, patients will be asked about their preoperative anxiety and expectations for postoperative pain. Preoperative patient-reported anxiety will be assessed by asking the question: \"On a scale from 1 to 100, how anxious are you regarding your upcoming surgery?\" Postoperative anticipated opioid need will be measured by asking, \"Do you anticipate requiring below average, average, or above average amount of pain medication following surgery?\". Preoperatively, patients will receive the first dose of suzetrigine (100 mg) approximately 1 hour prior to surgery. Midazolam can be used for anxiolysis as needed. Intraoperatively, patients will receive the usual intraoperative ERAS analgesic regimen used at Duke university typically incorporating intraoperative opioids (typically fentanyl and hydromorphone), intraoperative IV acetaminophen 1000 mg and IV ketorolac 15 mg. In PACU, IV fentanyl will be allowed for analgesia as per standard practice. Postoperative multimodal analgesia will incorporate scheduled acetaminophen, ibuprofen and suzetrigine (50 mg q12h, oral) around the clock. Oral oxycodone will be used for rescue as required. Patients will be encouraged to wait at least 60 minutes after taking a dose of acetaminophen and ibuprofen before use of the opioid rescue. Patients will be contacted daily to collect data about verbal rating pain scores (0= no pain, 10= worst possible pain), opioid consumption and any adverse events. In addition, on day 7, additional information will be collected about patient global assessment of pain control (poor, fair, good, very good, excellent).\n\nCases will be matched in a 1:2 ratio by age, race, insurance status, duration of surgery, preoperative anxiety and anticipated need for analgesia with historical controls who received postoperative analgesia using our current multimodal analgesic regimen. The historical controls will be identified from a database of patients who underwent minimally invasive hysterectomy with documented end points that the investigators are using in this study. Those patients also have information documented that was collected prospectively about anxiety and anticipated analgesic needs, factors that have been shown to be associated with postoperative opioid consumption.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Suzetrigine Group","EXPERIMENTAL","Suzetrigine added to standard multimodal analgesia",[55],"Drug: Suzetrigine",{"label":57,"type":58,"description":59,"interventionNames":44},"Control Group","NO_INTERVENTION","Standard Multimodal analgesia (historical cohort)",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"DRUG","Suzetrigine","Suzetrigine is an oral non-opioid pain medication used to treat moderate-to-severe acute pain in adults.",[51],[67],"Journavx",[69],{"name":70,"affiliation":5,"role":71},"Ashraf Habib","PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[75],{"name":76,"class":77},"Vertex Pharmaceuticals Incorporated","INDUSTRY","100657356","phase-4-suzetrigine-added-to-multimodal-analgesia-for-women-undergoing-minimally-invasive-hysterectomy-100657356",false,"NCT07836010","Suzetrigine Added to Multimodal Analgesia for Women Undergoing Minimally Invasive Hysterectomy","The Impact of Adding Suzetrigine to Multimodal Analgesia for Minimally Invasive Hysterectomy","Inclusion Criteria:\n\n* Patients ≥18 years presenting for a laparoscopic\u002Frobotic hysterectomy.\n* ASA Classification I-III.\n\nExclusion Criteria:\n\n* Chronic pain or chronic opioid therapy.\n* Allergy or contraindication to any component of the multimodal analgesic regimen.\n* Need to convert to an open procedure.\n* Subjects with severe hepatic or renal impairment and those receiving CYP3A inhibitors.\n* Inability to communicate pain scores or need for analgesics.\n* Suspected or known addiction to or abuse of illicit drugs, prescription medicine(s) or alcohol within the past 2 years.\n* Psychiatric disorders that, in the opinion of the investigator, may interfere with study assessments or compliance.\n* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.\n* Pregnancy.","FEMALE","18 Years","90 Years",{"count":89,"type":90},123,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","This study will assess the analgesic efficacy of suzetrigine as part of a multimodal analgesic regimen in women undergoing laparoscopic or robotic hysterectomy. Outcomes will be compared with matched historical controls receiving the current ERAS regimen without suzetrigine.",[96],"Postoperative Pain",[63,98,99],"Hysterectomy","Multimodal Analgesia","NOT_YET_RECRUITING","2026-09-17",{"date":103,"type":104},"2026-09-23","ACTUAL",{"date":106,"type":90},"2026-11",{"date":108,"type":90},"2028-02",{"name":5,"class":6}]