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

NCT ID: NCT02007096

Last Updated: 2018-01-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Ventral Hernia Umbilical Hernia Incisional Hernia Postoperative Complications Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transabdominal Plane Block

Receiving Transabdominal Plane Block with 0.25% bupivacaine

Group Type EXPERIMENTAL

Transabdominal Plane Block

Intervention Type DRUG

0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total

Non Transabdominal Plane Block

Receiving placebo saline injection

Group Type PLACEBO_COMPARATOR

Non Transabdominal Plane Block

Intervention Type DRUG

Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml

Interventions

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Transabdominal Plane Block

0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total

Intervention Type DRUG

Non Transabdominal Plane Block

Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml

Intervention Type DRUG

Other Intervention Names

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Bupivacaine Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Celia M. Divino

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celia M Divino, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

References

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Fields AC, Gonzalez DO, Chin EH, Nguyen SQ, Zhang LP, Divino CM. Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. J Am Coll Surg. 2015 Aug;221(2):462-9. doi: 10.1016/j.jamcollsurg.2015.04.007. Epub 2015 Apr 22.

Reference Type DERIVED
PMID: 26206644 (View on PubMed)

Other Identifiers

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GCO 12-0960

Identifier Type: -

Identifier Source: org_study_id

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