Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

NCT03342040 | Completed DMC

• 1 other identifier: GemHRC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

TAP block; laparoscopic IPOM; post operative pain

Outcome Measures

Primary Outcomes (1)

• Post operative cumulative analgesic requirement

  The amount of analgesic required by the patient during hospital stay

  24 hours after surgery

Secondary Outcomes (1)

• Post-operative hospital stay

  7 days from primary surgery

Study Arms (2)

TAP block

EXPERIMENTAL

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

Procedure: Laparoscopic ventral hernia repair with TAP block

No TAP block

ACTIVE COMPARATOR

Patients undergoing laparoscopic ventral hernia repair without TAP block

Procedure: Laparoscopic ventral hernia repair without TAP block

Interventions

Laparoscopic ventral hernia repair with TAP block PROCEDURE

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

Also known as: Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection

TAP block

Laparoscopic ventral hernia repair without TAP block PROCEDURE

No block administered during Laparoscopic ventral hernia surgery

No TAP block

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GEM Hospital & Research Center: lead

Study Sites (1)

Gem hospital and research centre

Coimbatore, Tamil Nadu, 641015, India

Location

MeSH Terms

Conditions

Hernia, Ventral; Pain, Postoperative

Interventions

Bupivacaine; Ropivacaine; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• C C Palanivelu, MS, MCh

  Gem Hospital and research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and assessors are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective double blinded balanced allocation, randomized clinical trial

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 14, 2017
• Study Start: October 15, 2017
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)