Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342040
• Other study ID #: GemHRC
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: GEM Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Laparoscopic ventral hernia repair with TAP block
Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery
• Laparoscopic ventral hernia repair without TAP block
No block administered during Laparoscopic ventral hernia surgery

Locations

Country	Name	City	State
India	Gem hospital and research centre	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative cumulative analgesic requirement	The amount of analgesic required by the patient during hospital stay	24 hours after surgery
Secondary	Post-operative hospital stay	The time taken to get discharged from the hospital	7 days from primary surgery