Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

February 13, 2019 updated by: GEM Hospital & Research Center

Randomized Clinical Trial: Transverse Abdominis Plane Block Versus no Block in Laparoscopic Ventral Hernia Repair

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641015
        • Gem Hospital and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP block
Patients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance
Procedure: Laparoscopic ventral hernia repair with TAP block
Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery
Other Names:
  • Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection
Active Comparator: No TAP block
Patients undergoing laparoscopic ventral hernia repair without TAP block
Procedure: Laparoscopic ventral hernia repair without TAP block
No block administered during Laparoscopic ventral hernia surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative cumulative analgesic requirement
Time Frame: 24 hours after surgery
The amount of analgesic required by the patient during hospital stay
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative hospital stay
Time Frame: 7 days from primary surgery
The time taken to get discharged from the hospital
7 days from primary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GEM Hospital & Research Center

Investigators

  • Principal Investigator: C C Palanivelu, MS, MCh, Gem Hospital and research center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GemHRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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