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

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Completed
Phase 2

Conditions

Postoperative Complications
Incisional Hernia
Umbilical Hernia
Ventral Hernia
Pain, Postoperative

Treatments

Drug: Non Transabdominal Plane Block
Drug: Transabdominal Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT02007096
GCO 12-0960

Details and patient eligibility

About

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.

Full 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.

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

127 participants in 2 patient groups, including a placebo group

Transabdominal Plane Block
Experimental group
Description:
Receiving Transabdominal Plane Block with 0.25% bupivacaine
Treatment:
Drug: Transabdominal Plane Block
Non Transabdominal Plane Block
Placebo Comparator group
Description:
Receiving placebo saline injection
Treatment:
Drug: Non Transabdominal Plane Block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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