The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Hernia

Intervention / Treatment
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* Procedure: Transversus abdominis plane block
* Procedure: Saline
* Procedure: Local infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline. | Procedure: Saline<br>* 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<br>* Other names: postoperative pain.;|
| Active Comparator: Local infiltration<br>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<br>* 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<br>* Other names: Local wound infiltration;|
| Experimental: Transversus abdominis plane block<br>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<br>* 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<br>* Other names: postoperative pain, UL-guided block;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus abdominis plane block