Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

NCT ID: NCT03342040

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2019-02-01

Brief Summary

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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

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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.

Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective double blinded balanced allocation, randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and assessors are masked

Study Groups

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TAP block

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

Group Type EXPERIMENTAL

Laparoscopic ventral hernia repair with TAP block

Intervention Type PROCEDURE

Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery

No TAP block

Patients undergoing laparoscopic ventral hernia repair without TAP block

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral hernia repair without TAP block

Intervention Type PROCEDURE

No block administered during Laparoscopic ventral hernia surgery

Interventions

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Laparoscopic ventral hernia repair with TAP block

Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery

Intervention Type PROCEDURE

Laparoscopic ventral hernia repair without TAP block

No block administered during Laparoscopic ventral hernia surgery

Intervention Type PROCEDURE

Other Intervention Names

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Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEM Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C C Palanivelu, MS, MCh

Role: PRINCIPAL_INVESTIGATOR

Gem Hospital and research center

Locations

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Gem hospital and research centre

Coimbatore, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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GemHRC

Identifier Type: -

Identifier Source: org_study_id

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