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Clinical Trials/NCT03342040
NCT03342040CompletedNot Applicable

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

GEM Hospital & Research Center2 sites in 1 country90 target enrollmentStarted: October 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Post operative cumulative analgesic requirement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participant and assessors are masked

Eligibility Criteria

Ages
15 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Age <15 or greater than 75 years
  • 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

Arms & Interventions

TAP block

Experimental

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

Intervention: Laparoscopic ventral hernia repair with TAP block (Procedure)

No TAP block

Active Comparator

Patients undergoing laparoscopic ventral hernia repair without TAP block

Intervention: Laparoscopic ventral hernia repair without TAP block (Procedure)

Outcomes

Primary Outcomes

Post operative cumulative analgesic requirement

Time Frame: 24 hours after surgery

The amount of analgesic required by the patient during hospital stay

Secondary Outcomes

  • Post-operative hospital stay(7 days from primary surgery)

Investigators

Sponsor
GEM Hospital & Research Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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