[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657422":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":73,"overallOfficials":44,"centralContacts":136,"locations":142,"responsibleParty":159,"collaborators":44,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":165,"sex":171,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":44,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":145,"whyStopped":44,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Northwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Curve (AUC) of Postoperative Pain Scores","Postoperative pain will be measured using the Numeric Rating Scale (NRS, 0-10) at standardized 6-hour intervals over the first four postoperative days. The area under the curve of these serial measurements will be calculated to reflect cumulative postoperative pain burden.","Postoperative Day 1 through Postoperative Day 4",[14,18,21,24,27,31,35,38,41],{"measure":15,"description":16,"timeFrame":17},"Total Postoperative Opioid Consumption","Total opioid consumption during hospitalization, measured in oral morphine milligram equivalents (MME). For patients receiving epidural analgesia, neuraxial opioid use will be quantified and reported separately from oral\u002Fintravenous MME.","Through hospital discharge, an average of 5 days",{"measure":19,"description":20,"timeFrame":17},"Length of Hospital Stay","Total number of days from surgery to hospital discharge.",{"measure":22,"description":23,"timeFrame":17},"Incidence of Postoperative Ileus","Postoperative ileus, defined as the requirement for nasogastric tube decompression.",{"measure":25,"description":26,"timeFrame":17},"Incidence of Epidural-Related Complications","Hypotension (defined as a drop in systolic blood pressure or mean arterial pressure of more than 20% from baseline) and urinary retention requiring Foley catheter reinsertion.",{"measure":28,"description":29,"timeFrame":30},"Patient Satisfaction with Pain Management (Binary)","Patient satisfaction with postoperative pain management, assessed prior to discharge using a binary (yes\u002Fno) question.","At hospital discharge",{"measure":32,"description":33,"timeFrame":34},"30-Day Postoperative Complications","Incidence of wound complications, respiratory complications, hospital readmission, reoperation, and hernia recurrence, assessed as part of standard of care data collection.","30 days (± 15 days) postoperatively",{"measure":36,"description":37,"timeFrame":34},"30-Day Postoperative Opioid Prescribing and Consumption","Number and dose of opioids prescribed, and total opioids consumed, in the 30 days following surgery",{"measure":39,"description":40,"timeFrame":30},"Patient Satisfaction with Pain Management (Numeric Scale)","Patient satisfaction with postoperative pain management, assessed prior to discharge using a 1-10 numeric satisfaction scale, with higher scores indicating greater satisfaction.",{"measure":42,"description":43,"timeFrame":12},"Daily Average Numeric Rating Scale Pain Score","Average Numeric Rating Scale (NRS) pain score calculated for each of the first four postoperative days, on a scale of 1-10, with 0 meaning no pain and 10 being the worst pain imaginable",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52,61],{"label":53,"type":54,"description":55,"interventionNames":56},"Epidural Analgesia","ACTIVE_COMPARATOR","Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine\u002Ffentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.",[57,58,59,60],"Drug: Bupivicaine","Drug: Fentanyl","Device: Thoracic epidural analgesia","Drug: Hydromorphone",{"label":62,"type":63,"description":64,"interventionNames":65},"Opioid-Sparing Multimodal Analgesia","EXPERIMENTAL","Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.",[60,66,67,68,69,70,71,72],"Drug: Acetaminophen","Drug: Ketorolac","Drug: magnesium sulfate","Drug: Tramadol","Drug: Gabapentin","Drug: Cyclobenzaprine","Procedure: transversus abdominis plane block",[74,79,83,90,96,103,109,113,119,123,129],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":44},"DRUG","Bupivicaine","Local anesthetic administered via thoracic epidural catheter, both as an intraoperative bolus and as part of a standardized postoperative continuous infusion combined with fentanyl, discontinued on postoperative day 3.",[53],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":44},"Fentanyl","Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.",[53],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"DEVICE","Thoracic epidural analgesia","Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.",[53],[89],"Epidural catheter",{"type":75,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"Hydromorphone","Opioid administered intravenously via patient-controlled analgesia (PCA) as rescue therapy for participants in either study arm who have inadequate pain control with their assigned analgesia protocol.",[53,62],[95],"dilaudid",{"type":75,"name":97,"description":98,"armGroupLabels":99,"otherNames":100},"Acetaminophen","Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.",[62],[101,102],"tylenol","Paracetamol",{"type":75,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"Ketorolac","Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.",[62],[108],"toradol",{"type":75,"name":110,"description":111,"armGroupLabels":112,"otherNames":44},"magnesium sulfate","Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.",[62],{"type":75,"name":114,"description":115,"armGroupLabels":116,"otherNames":117},"Tramadol","Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.",[62],[118],"ultram",{"type":75,"name":120,"description":121,"armGroupLabels":122,"otherNames":44},"Gabapentin","Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.",[62],{"type":75,"name":124,"description":125,"armGroupLabels":126,"otherNames":127},"Cyclobenzaprine","Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.",[62],[128],"Flexeril",{"type":130,"name":131,"description":132,"armGroupLabels":133,"otherNames":134},"PROCEDURE","transversus abdominis plane block","Regional anesthetic technique performed intraoperatively by the surgeon, injecting local anesthetic into the transversus abdominis plane of the abdominal wall, as part of the opioid-sparing multimodal analgesia protocol.",[62],[135],"TAP block",[137],{"name":138,"role":139,"phone":140,"phoneExt":44,"email":141},"Nancy Ly, MD","CONTACT","3126956868","nancy.ly@nm.org",[143],{"facility":144,"status":145,"city":146,"state":147,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":156,"contacts":157},"Northwestern Memorial Hospital","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":152,"coordinates":153},"Point",[154,155],-87.65005,41.85003,{"lat":155,"lon":154},[158],{"name":138,"role":139,"phone":140,"phoneExt":44,"email":141},{"type":160,"investigatorFullName":161,"investigatorTitle":162,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Megan Melland-Smith","Assistant Professor","100657422","phase-4-epidural-analgesia-versus-opioid-sparing-analgesia-for-open-ventral-hernia-repair-with-transversus-abdominis-release-100657422",false,"NCT07840183","Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release","Epidural Analgesia verSus Opioid-sparing analgEsia Protocol for Pain Control Following Open Ventral Hernia Repair With Transversus Abdominis Release: A Randomized Controlled Trial","EASE-TAR","Inclusion Criteria:\n\n* Male or female patients ≥18 years old\n* Symptomatic incisional ventral or parastomal hernias\n* Planned transversus abdominis release\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Contraindications to epidural placement\n* Chronic pre-operative opioid use, defined as daily opioid use for 30-days prior to surgery\n* Allergy or intolerance to study medications\n* Age greater than 80 years\n* Impaired renal function - defined as creatinine clearance or estimated GFR of \\\u003C60ml\u002Fmin\n* Planned ICU admissions with post-operative intubation\n* Urgent or emergent presentations\n* Adults unable to consent\n* Pregnant patients","ALL","18 Years","80 Years",{"count":175,"type":176},40,"ESTIMATED","INTERVENTIONAL",[179],"PHASE4","This study is comparing two ways to manage pain after a major hernia repair surgery called \"transversus abdominis release.\" One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. The other method avoids the epidural and instead uses a combination of non-opioid pain medicines, along with an injection of numbing medicine into the abdominal wall during surgery. Patients who still have pain that is hard to control with either method will be given rescue pain medicine through an intravenous (IV) pump.\n\nResearchers want to learn which method controls pain better and results in patients using fewer opioid pain medicines after surgery. Participants will be randomly assigned (like a coin flip) to one of the two pain control methods. Pain levels and medication use will be tracked during the hospital stay, and participants will be contacted 30 days after surgery to check on recovery and any side effects.",[182,183,184],"Ventral Hernia","Ventral Hernia Repair","Postoperative Pain",[186,187,188,189],"ventral hernia","complex abdominal wall hernia","ventral hernia repair","postoperative pain control","2026-10-06",{"date":192,"type":193},"2026-10-07","ACTUAL",{"date":195,"type":193},"2026-09-25",{"date":197,"type":176},"2027-11",{"name":5,"class":6},1]