Lap TAP Block for Laparoscopic TEP Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial

NCT02632136 | Unknown Phase 3 DMC

• 1 other identifier: MGHIreland
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

A newly developed technique of TAP block solely performed by surgeons will be used for postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the periportal wound infiltration in controlling the postoperative pain.

Conditions

Laparoscopic TAP Block in TEP Inguinal Hernia Repair.

Keywords

Laparoscopic; TAP Block; Total extra peritoneal Inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Numerical Analogue score for pain will be recorded at 1, 3, 6 and 24 hours post surgery

  Within 24 hours post surgery

Secondary Outcomes (2)

• Total opioid usage

  within 24 hours perioperative period

• Post operative nausea or vomiting

  24 hours post operative period

Study Arms (2)

TAP block group

ACTIVE COMPARATOR

This group will receive 30 ml of 0.25% Bupivacine given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine. They will also receive normal saline injections at port sites, which will be injected before the ports are inserted. 15 ml of normal saline will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports.

Drug: TAP Block Group

Peri-Portal block Group

PLACEBO COMPARATOR

They will receive 0.5% Bupivacaine injections at port sites, which will be injected before the ports are inserted. 15 ml of 0.5% Bupivacaine will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports. This group will also receive 30 ml of Normal Saline Injection given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine.

Drug: Peri-Portal Block Group

Interventions

TAP Block Group DRUG

Transversus Abdominus Plane (TAP) block: Bupivacaine (30 ml of 0.25%)is injected between internal oblique and transveralis facia. The location of needle and the bleb that is formed after the injection is inspected under diect laparoscopic vision.

Also known as: 0.25% Bupivacaine

TAP block group

Peri-Portal Block Group DRUG

15 ml of 0.5% Bupivacaine is injected in the skin and subcutaneous tissue before inserting the ports. 7 ml out of it is injected at sub-umblical port and 4 ml each a the site of other two ports.

Also known as: 0.5% Bupivacaine

Peri-Portal block Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive ASA grade I-II- III patients undergoing elective unilateral laparoscopic total extra peritoneal (TEP) Inguinal hernia repair
• Age 18 - 80 yrs, including those who are having recurrent inguinal hernia repair.

You may not qualify if:

• ASA grade IV, V
• Bilateral inguinal hernia repair
• BMI \> 40 kg/m2
• Converted to open procedures.
• Conversion to Transabdominal preperitoneal (TAPP) repair
• Coagulopathy.
• Allergy to Bupivacaine.
• Diagnosis of "chronic pain syndrome".
• Known alcohol or substance abuse within the last 6 months.
• Daily Opioid intake.

Sponsors & Collaborators

• Mayo General Hospital, Ireland: lead

Study Sites (1)

Mayo University Hospital

Castlebar, Mayo, F23 EH39, Ireland

RECRUITING

Related Publications (3)

• Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.

  PMID: 25899736 BACKGROUND

• Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.

  PMID: 21401554 RESULT

• Kim MG, Kim SI, Ok SY, Kim SH, Lee SJ, Park SY, Yoo JH, Cho A, Hur KY, Kim MJ. Is transverse abdominis plane block effective following local anesthetic infiltration in laparoscopic totally extraperitoneal hernia repair? Korean J Anesthesiol. 2014 Dec;67(6):398-403. doi: 10.4097/kjae.2014.67.6.398. Epub 2014 Dec 29.

  PMID: 25558340 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Asif Khan, MBBS, MRCSI

  Mayo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asif Khan, MBBS, MRCSI

CONTACT

00353894171595; asif_21khan@yahoo.com

Iqbal Z Khan, MRCSI, FRCSI

CONTACT

00353868214999; iqbalzkhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar, General Surgery

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 16, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 16, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

IE (1)