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

Primary Purpose

Ventral Hernia, Umbilical Hernia, Incisional Hernia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transabdominal Plane Block
Non Transabdominal Plane Block
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventral Hernia focused on measuring Transabdominal plane block, ventral hernia, umbilical hernia, incisional hernia, hernia repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transabdominal Plane Block

Non Transabdominal Plane Block

Arm Description

Receiving Transabdominal Plane Block with 0.25% bupivacaine

Receiving placebo saline injection

Outcomes

Primary Outcome Measures

Post-operative Opioid Use
Amount of opioids used by patients at certain time points.

Secondary Outcome Measures

Pain Score
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."
Operating Procedure Time
Total number of minutes for the procedure, not including anesthesia time.
Pain Score
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."

Full Information

First Posted
December 5, 2013
Last Updated
January 17, 2018
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02007096
Brief Title
Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?
Official Title
Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Umbilical Hernia, Incisional Hernia, Postoperative Complications, Pain, Postoperative
Keywords
Transabdominal plane block, ventral hernia, umbilical hernia, incisional hernia, hernia repair

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transabdominal Plane Block
Arm Type
Experimental
Arm Description
Receiving Transabdominal Plane Block with 0.25% bupivacaine
Arm Title
Non Transabdominal Plane Block
Arm Type
Placebo Comparator
Arm Description
Receiving placebo saline injection
Intervention Type
Drug
Intervention Name(s)
Transabdominal Plane Block
Other Intervention Name(s)
Bupivacaine
Intervention Description
0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total
Intervention Type
Drug
Intervention Name(s)
Non Transabdominal Plane Block
Other Intervention Name(s)
Saline
Intervention Description
Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml
Primary Outcome Measure Information:
Title
Post-operative Opioid Use
Description
Amount of opioids used by patients at certain time points.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Pain Score
Description
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."
Time Frame
1 hour postoperatively
Title
Operating Procedure Time
Description
Total number of minutes for the procedure, not including anesthesia time.
Time Frame
Procedure begin time to procedure end time
Title
Pain Score
Description
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."
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia M Divino, MD, FACS
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26206644
Citation
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.
Results Reference
derived

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

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