[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587189":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":59,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Tennessee","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo group","PLACEBO_COMPARATOR","Placebo group TAP (Transversus Abdominis Plane) block syringe will include 30mL normal saline.",[13],"Drug: Placebo arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","ACTIVE_COMPARATOR","TAP (Transversus Abdominis Plane) blocks will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine.",[19],"Drug: Bupivicaine intervention arm",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivicaine intervention arm","TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo arm","Placebo group TAP block syringe will include 30mL normal saline",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Michael VanDillen Fellow physician, PI of study, MD","CONTACT","314-619-1046","mvandill@uthsc.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Regional One Health","RECRUITING","Memphis","Tennessee","38103","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-90.04898,35.14953,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":35,"phoneExt":26,"email":36},"Michael Vandillen, MD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Michael B VanDillen MD","Principal Investigator",[60],{"name":39,"class":6},"100587189","phase-4-comfort-trial-complex-obstetric-management-with-focused-regional-transversus-abdominis-plane-block-100587189",false,"NCT06925152","COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block","COMFORT","Inclusion criteria:\n\nPatient has a history of a least one of the following:\n\n* Prior exploratory laparotomy\n* History of non-obstetric open intra-abdominal surgery\n* History of three or more prior cesarean deliveries\n* History of intra-abdominal or pelvic adhesive disease\n* History of abdominoplasty\n* History of abdominal re-exploration surgery\n\nExclusion Criteria:\n\n* Received general anesthesia\n* History of less than 3 cesarean deliveries if do not meet other inclusion criteria\n* History of chronic opioid use\n* History of substance abuse (i.e. alcohol, methamphetamine\u002Famphetamine, abuse of prescription opioid medication, or heroin use)\n* History of chronic kidney disease\n* Allergies to bupivacaine or oral analgesics\n* Patient preference\n* Cesarean hysterectomy\n* Administration of ≥4mg morphine to epidural\n* Loss to follow-up","FEMALE","18 Years","50 Years",{"count":72,"type":73},120,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).",[79,80,81,82],"Complex Obstetric Surgery","Perioperative Pain Management","Cesarean Delivery","Postoperative Pain Control",[84,85,86,87],"Complex obstetric surgery","Perioperative pain management","cesarean delivery","postoperative pain control","2026-03-08",{"date":90,"type":91},"2026-03-11","ACTUAL",{"date":93,"type":91},"2025-07-15",{"date":95,"type":73},"2028-05",{"name":5,"class":6},1]