The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

Phase 4

Completed

• Conditions: Hernia
• Interventions: Procedure: Saline; Procedure: Local infiltration; Procedure: Transversus abdominis plane block

• Registration Number: NCT01052285
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Study Start: 2010-06
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-17
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.
Local infiltration	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
Transversus abdominis plane block	Transversus abdominis plane block	25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesiology, Glostrup university hospital; 🇩🇰 Glostrup, Denmark