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Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Laparoscopic ventral hernia repair with TAP block
Laparoscopic ventral hernia repair without TAP block
Sponsored by
GEM Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring TAP block, laparoscopic IPOM, post operative pain

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing laparoscopic ventral hernia repair during the study period

Exclusion Criteria:

  • Age <15 or greater than 75 years
  • ASA > 3
  • Obstructed , recurrent or strangulated hernia
  • Lap assisted open hernia repair
  • Patients undergoing component separation
  • Parastomal hernia, spigelian hernia, lumbar hernia
  • Patients with Chronic kidney disease, bronchial asthma
  • Patients allergic to bupivacaine or NSAIDs
  • Not willing to participate

Sites / Locations

  • Gem hospital and research centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block

No TAP block

Arm Description

Patients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance

Patients undergoing laparoscopic ventral hernia repair without TAP block

Outcomes

Primary Outcome Measures

Post operative cumulative analgesic requirement
The amount of analgesic required by the patient during hospital stay

Secondary Outcome Measures

Post-operative hospital stay
The time taken to get discharged from the hospital

Full Information

First Posted
September 29, 2017
Last Updated
February 13, 2019
Sponsor
GEM Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03342040
Brief Title
Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair
Official Title
Randomized Clinical Trial: Transverse Abdominis Plane Block Versus no Block in Laparoscopic Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GEM Hospital & Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.
Detailed Description
Patients meeting inclusion criteria would be randomised after admission. Those patients in experimental arm shall receive the TAP block under USG guidance while those in control arm do not receive any block. Surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. The total amount of analgesic required by the patient is measured. Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow up review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
TAP block, laparoscopic IPOM, post operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective double blinded balanced allocation, randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participant and assessors are masked
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance
Arm Title
No TAP block
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic ventral hernia repair without TAP block
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral hernia repair with TAP block
Other Intervention Name(s)
Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection
Intervention Description
Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral hernia repair without TAP block
Intervention Description
No block administered during Laparoscopic ventral hernia surgery
Primary Outcome Measure Information:
Title
Post operative cumulative analgesic requirement
Description
The amount of analgesic required by the patient during hospital stay
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Post-operative hospital stay
Description
The time taken to get discharged from the hospital
Time Frame
7 days from primary surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing laparoscopic ventral hernia repair during the study period Exclusion Criteria: Age <15 or greater than 75 years ASA > 3 Obstructed , recurrent or strangulated hernia Lap assisted open hernia repair Patients undergoing component separation Parastomal hernia, spigelian hernia, lumbar hernia Patients with Chronic kidney disease, bronchial asthma Patients allergic to bupivacaine or NSAIDs Not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C C Palanivelu, MS, MCh
Organizational Affiliation
Gem Hospital and research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gem hospital and research centre
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641015
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

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