Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Post-operative Opioid Use
Study Overview
Brief Summary
The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.
Detailed Description
Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 18 and older
- •elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital
Exclusion Criteria
- •age younger than 18
- •allergic reaction to bupivacaine
- •allergic reaction to opioids
- •opioid substance abuse
Arms & Interventions
Transabdominal Plane Block
Receiving Transabdominal Plane Block with 0.25% bupivacaine
Intervention: Transabdominal Plane Block (Drug)
Non Transabdominal Plane Block
Receiving placebo saline injection
Intervention: Non Transabdominal Plane Block (Drug)
Outcomes
Primary Outcomes
Post-operative Opioid Use
Time Frame: up to 24 hours
Amount of opioids used by patients at certain time points.
Secondary Outcomes
- Operating Procedure Time(Procedure begin time to procedure end time)
- Pain Score(24 hours postoperatively)
Investigators
Celia M. Divino
Professor
Icahn School of Medicine at Mount Sinai