Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

Phase 2

Completed

• Conditions: Incisional Hernia; Pain, Postoperative; Ventral Hernia; Umbilical Hernia; Postoperative Complications
• Interventions: Drug: Transabdominal Plane Block; Drug: Non Transabdominal Plane Block

• Registration Number: NCT02007096
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2017-04-03
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Results First Posted: 2018-01-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transabdominal Plane Block	Transabdominal Plane Block	Receiving Transabdominal Plane Block with 0.25% bupivacaine
Non Transabdominal Plane Block	Non Transabdominal Plane Block	Receiving placebo saline injection

Primary Outcome Measures

Name	Time	Method
Post-operative Opioid Use	up to 24 hours	Amount of opioids used by patients at certain time points.

Secondary Outcome Measures

Name	Time	Method
Operating Procedure Time	Procedure begin time to procedure end time	Total number of minutes for the procedure, not including anesthesia time.
Pain Score	24 hours postoperatively	Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States