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

Glostrup University Hospital, Copenhagen1 site in 1 country90 target enrollmentJune 2010

ConditionsHernia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hernia
Sponsor: Glostrup University Hospital, Copenhagen
Enrollment: 90
Locations: 1
Primary Endpoint: Pain scores by coughing between TAP block group and placebo group
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glostrup University Hospital, Copenhagen

Responsible Party

Principal Investigator

Pernille Lykke Petersen

Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

•18-75 years old
•groin hernia repair
•written consent
•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

Outcomes

Primary Outcomes

Pain scores by coughing between TAP block group and placebo group

Time Frame: 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 Outcomes

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)
Total opioid consumption(0-24 hours postoperative)
Postoperative nausea and vomiting(0,2,4,6,8,19,24 hours postoperative)
Sedation(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)