The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052285
• Other study ID #: SM1-plp-10
• Secondary ID: 2010-018403-29
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: November 17, 2011
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology, Glostrup university hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Total opioid consumption	Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.	0-24 hours postoperative	No
Secondary	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	No
Secondary	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	No
Secondary	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	No