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Completed

NCT Number: NCT03342040

Transverse Abdominis Plane 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.

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Key information

Conditions

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

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gem hospital and research centre

Coimbatore, Tamil Nadu, 641015, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic ventral hernia repair with TAP block

Procedure

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

Laparoscopic ventral hernia repair without TAP block

Procedure

No block administered during Laparoscopic ventral hernia surgery

Primary outcomes

  1. Post operative cumulative analgesic requirement

    Time frame: 24 hours after surgery

    The amount of analgesic required by the patient during hospital stay

Secondary outcomes

  1. Post-operative hospital stay

    Time frame: 7 days from primary surgery

    The time taken to get discharged from the hospital

Sponsors and collaborators

Lead sponsor

GEM Hospital & Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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