Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Procedure: Laparoscopic ventral hernia repair with TAP block; Procedure: Laparoscopic ventral hernia repair without TAP block

• Registration Number: NCT03342040
• Lead Sponsor: GEM Hospital & Research Center

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 Timeline

• Study First Submitted: 2017-09-29
• Study Start: 2017-10-15
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-14
• Primary Completion: 2019-01-01
• Status Verified: 2019-02
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block	Laparoscopic ventral hernia repair with TAP block	Patients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance
No TAP block	Laparoscopic ventral hernia repair without TAP block	Patients undergoing laparoscopic ventral hernia repair without TAP block

Primary Outcome Measures

Name	Time	Method
Post operative cumulative analgesic requirement	24 hours after surgery	The amount of analgesic required by the patient during hospital stay

Secondary Outcome Measures

Name	Time	Method
Post-operative hospital stay	7 days from primary surgery	The time taken to get discharged from the hospital

Trial Locations

Locations (1)

Gem hospital and research centre; 🇮🇳 Coimbatore, Tamil Nadu, India