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

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

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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