Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal wall reconstruction population using an intraoperative local anesthetic infusion. A prospective randomized double blind study of patients undergoing component separation will be performed in order to assess the following outcomes:

1. Length of Stay (LOS)

2. Return of bowel function

3. Narcotic pain medication requirements

4. Nausea and emesis

5. Pain scores


Clinical Trial Description

One group will be the control group (group A) and the other will be the study group (group B). Neither patient nor physician will know which group they have been assigned. Informed consent will be obtained during pre-operative evaluation in the clinic prior to the day of surgery as stated above. Relevant medical history will be entered into a secure database. Information collected will include patient demographics, medical co-morbidities, history of prior procedures, preoperative pain scores, postoperative nausea, emesis, pain scores, dermatomal anesthesia, adjuvant narcotic usage, return of bowel function and length of stay (LOS).

Patients will be randomly separated into 2 groups at the time of surgery through the randomization log of the investigational drug service (IDS) pharmacy. At the request of the attending surgeon a solution will be prepared and delivered to the operating room in a blinded fashion concealed within a shielded vial.

During the abdominal component separation, dissection of the tissue planes housing the sensory fibers will be exposed to allow insertion of a large spinal needle under direct visualization on each side of the abdominal wall. Depending on the study group, the attending surgeon will inject an unknown solution (solution A or B) of either 30ml of Exparel ((bupivacaine liposome injectable suspension) 1.3% ( 13.3mg/ml)). The final test solution will be prepared in the IDS pharmacy by adding a 20 mL Exparel vial and 40cc of normal saline for a total of 60cc with a bupivacaine concentration of 0.44%. This will then be split into two 30cc solutions to be injected into each side of the transverse abdominal plane. A patient in the placebo group will be injected with 30cc of Normal Saline into the TAP region on each side of the abdomen.

All patients, independent of their study group will be provided with Patient Controlled Analgesics (PCA) using Hydromorphone or orally dosed narcotic/acetaminophen combo analgesics to ensure adequate post-operative pain control. The pain scores, dermatomal level of anesthesia, nausea, emesis, return of bowel function and length of stay will be logged into the electronic medical record. Once data collection is complete the groups will be revealed and all of the data will undergo statistical analysis. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02274077
Study type Interventional
Source University of Rochester
Contact
Status Withdrawn
Phase Phase 4
Start date January 2016
Completion date June 2017

See also
  Status Clinical Trial Phase
Recruiting NCT06051578 - Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
Recruiting NCT04098380 - Small Versus Large Bite Closure of Emergency Midline Laparotomy N/A
Completed NCT02616718 - Incisional Hernia Progression Over Time N/A
Completed NCT06034652 - T-GENVIH-003 LTFU (Long Term Follow Up) Study
Completed NCT04222517 - The Use of Local Hemostatic in Patients With Large Incisional Hernias N/A
Completed NCT00749268 - AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair Phase 4
Not yet recruiting NCT05467124 - Enhanced Recovery After Abdominal Wall Reconstruction
Completed NCT00472537 - ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment N/A
Active, not recruiting NCT02365194 - Modifying Risk in Ventral Hernia Patients N/A
Recruiting NCT04718168 - GORE® ENFORM Biomaterial Product Study N/A
Completed NCT02594241 - PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial N/A
Active, not recruiting NCT02363790 - Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial N/A
Completed NCT02398565 - Pregnancy Subsequent to Ventral Hernia Repair N/A
Terminated NCT02041494 - Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh N/A
Completed NCT00532870 - Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair N/A
Completed NCT05320055 - Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair
Completed NCT04229940 - Peritoneal in Laparoscopic Ventral Hernia Repair 2 Phase 2
Completed NCT05446675 - Endoscopic eTEP Versus Open Rives-Stoppa
Completed NCT05912868 - Endoscopic Mini/Less Open Sublay(EMILOS) Repair
Not yet recruiting NCT06449378 - Transorbâ„¢ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia N/A