[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556487":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":74,"collaborators":34,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":34,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":34,"maxAge":34,"enrollmentInfo":85,"targetDuration":34,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":34,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (methadone)","EXPERIMENTAL","Patients receive methadone IV during induction of general anesthesia for SOC surgery.",[13,14],"Drug: Methadone","Other: Questionnaire Administration",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm II (hydromorphone)","Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.",[19,14],"Drug: Hydromorphone",[21,30,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Hydromorphone","Given IT",[16],[27,28,29],"(-)-Hydromorphone","Dihydromorphinone","Hydromorphon",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Methadone","Given IV",[9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Questionnaire Administration","Ancillary studies",[9,16],[40],{"name":41,"affiliation":42,"role":43},"Sean C. Dowdy, M.D.","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":51,"role":47,"phone":52,"phoneExt":34,"email":53},"Karen Ishitani, R.N.","507-538-5355","Ishitani.Karen@mayo.edu",[55],{"facility":42,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-92.4699,44.02163,{"lat":66,"lon":65},[69,70,72],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},{"name":71,"role":47,"phone":52,"phoneExt":34,"email":53},"Karen Ishitani, RN",{"name":73,"role":43,"phone":34,"phoneExt":34,"email":34},"Sean C. Dowdy, MD.",{"type":43,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Sean C Dowdy, MD","Principal Investigator","100556487","phase-4-methadone-versus-intrathecal-hydromorphone-for-postoperative-pain-relief-in-gynecologic-cancer-undergoing-surgery-100556487",false,"NCT06525740","Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery","Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine","Inclusion Criteria:\n\n* Undergoing surgery with a laparotomy for gynecologic malignancy\n* Planned inpatient admission greater than 24 hours\n\nExclusion Criteria:\n\n* Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient\n* Prolonged corrected QT interval (QTc) \\> 500ms\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \\\u003C 30 milliliters per minute (mL\u002Fmin)\n* Documented cirrhosis\n* Preoperative platelets (PLT) \\\u003C 100\n* Preoperative international normalized ratio (INR) \\> 1.1\n* Inappropriate cessation of anticoagulation medications prior to surgery\n* Intolerance to hydromorphone or methadone\n* Contraindication to administration of liposomal bupivacaine\n* Subsequent surgeries after index surgery","FEMALE",{"count":86,"type":87},140,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.",[93],"Malignant Female Reproductive System Neoplasm","2026-03-02",{"date":96,"type":97},"2026-03-04","ACTUAL",{"date":99,"type":97},"2024-09-03",{"date":101,"type":87},"2029-09-01",{"name":5,"class":6},1]