[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07518238":3,"trial-entities:NCT07518238":97,"trial-summary:NCT07518238":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":76,"locations":79,"central_contacts":89,"overall_officials":90,"references":95,"see_also_links":96},"NCT07518238","025-448","Hernia Abd Wall Recons - BDE vs Exparel","Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction","ENROLLING_BY_INVITATION","2029-11-12","2026-03","2026-04-08","2026-01-13","Baylor Research Institute","OTHER",false,"This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.","This will be a prospective randomized controlled trial comparing the outcomes of hernia patients receiving BDE versus Exparel before abdominal wall reconstruction. The study will utilize the pain numeric rating scale (PNRS) validated questionnaire to assess pain levels. Patients will be asked to report their worst pain imaginable.",[19,20],"BDE for Hernia Patients","Exparel for Hernia Patients",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},128,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","BDE Injectable Drug","Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction",[35],"BDE for hernia patients",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Exparel Injectable Drug","Exparel for hernia patients receiving abdominal wall reconstruction",[40],"Exparel for hernia patients",[42,46,50],{"measure":43,"description":44,"timeFrame":45},"Morphine Milligram Equivalent","To evaluate the difference in medication usage\u002F Morphine Milligram Equivalent (MME) between the two groups","Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)",{"measure":47,"description":48,"timeFrame":49},"Pain control","Compre efficacy in pain control by using the PNRS Questionniare","Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)",{"measure":51,"description":52,"timeFrame":53},"Hospital Stay","To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel.","30-45 days after hospital discharge",[55,58],{"measure":56,"description":57,"timeFrame":53},"Bowel Function","To assess the time to return of bowel function in both groups.",{"measure":59,"description":60,"timeFrame":53},"Total Cost","To compare the total cost between the two groups.","ALL","18 Years",null,{"inclusion":65,"exclusion":68,"raw_text":75},[66,67],"Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study","Patients 18 years and above",[69,70,71,72,73,74],"Patients not undergoing abdominal wall reconstruction surgery","Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.","Patients less than 18 years old","Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.","Patients undergoing additional planned surgical procedures during the same admission","History of chronic pain or chronic opioid use Known allergy to BDE or Exparel or to drugs included as part of multimodal regimen { acetaminophen, gabapentin or Lyrica (pregabalin)}.","Inclusion Criteria:\n\n* Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study\n* Patients 18 years and above\n\nExclusion Criteria:\n\n* Patients not undergoing abdominal wall reconstruction surgery\n* Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.\n* Patients less than 18 years old\n* Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.\n* Patients undergoing additional planned surgical procedures during the same admission\n* History of chronic pain or chronic opioid use Known allergy to BDE or Exparel or to drugs included as part of multimodal regimen { acetaminophen, gabapentin or Lyrica (pregabalin)}.",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Baylor University Medical Center","Dallas","Texas","75246","United States",{"lat":87,"lon":88},32.78306,-96.80667,[],[91],{"name":92,"affiliation":93,"role":94},"Bola Aladegbami, MD","Baylor Scott and White Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Hernia",[],{"nct_id":4,"found":15,"summary":63,"prompt_version":63}]