The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Procedure: Saline; Procedure: Local infiltration; Procedure: Transversus abdominis plane block

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Department of Anaesthesiology, Glostrup University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-75 years old
• groin hernia repair
• written consent
• ASA 1-3
• BMI 18-35

Exclusion Criteria:

• unable to communicate in Danish
• relevant drug allergy
• pain medication in the last 24 hours
• pregnancy
• alcohol or/and drug abuse
• daily opioid intake
• infection at injection site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.	Procedure: Saline; UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose; Other Names: postoperative pain.
Active Comparator: Local infiltration; Ilioinguinal block with 10 ml of ropivacaine 0,375% Local infiltration with 40 ml of ropivacaine 0,375% Tap block with 25 ml of saline	Procedure: Local infiltration; Ilioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose; Other Names: Local wound infiltration
Experimental: Transversus abdominis plane block; 25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.	Procedure: Transversus abdominis plane block; UL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline; Other Names: postoperative pain, UL-guided block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores by coughing between TAP block group and placebo group	Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative	0,2,4,6,8,19 and 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.	Area under the curve (AUC)-pain during cough based on measurements 0,2,4,6,8,19,24 hours postoperative.	0,2,4,6,8,19 and 24 hours postoperative
Total opioid consumption	Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.	0-24 hours postoperative
Postoperative nausea and vomiting	Levels of nausea (0-3)at 0,2,4,6,8,19,24 hours postoperative Number of vomits 0-2, 2-4, 4-6, 6-8, 8-19 og 19-24 hours postoperative.	0,2,4,6,8,19,24 hours postoperative
Sedation	Levels of sedation (0-3)at 0,2,4,6,8,19,24 hours postoperative.	0,2,4,6,8,19,24 hours postoperative
Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo	Area under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative	0,2,4,6,8,19,24 hours postoperative

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Pernille L Petersen, MD, Glostrup University Hospital

Publications and helpful links

General Publications

• Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Transversus abdominis plane block
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: SM1-plp-10; 2010-018403-29 (EudraCT Number)