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The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

Primary Purpose

Hernia

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Transversus abdominis plane block
Saline
Local infiltration
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Transversus abdominis plane block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anaesthesiology, Glostrup university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Local infiltration

Transversus abdominis plane block

Arm Description

TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.

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

25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Total opioid consumption
Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 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.
Sedation
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
Area under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative

Full Information

First Posted
January 19, 2010
Last Updated
November 17, 2011
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01052285
Brief Title
The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair
Official Title
The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Transversus abdominis plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.
Arm Title
Local infiltration
Arm Type
Active Comparator
Arm Description
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
Arm Title
Transversus abdominis plane block
Arm Type
Experimental
Arm Description
25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Other Intervention Name(s)
postoperative pain, UL-guided block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Saline
Other Intervention Name(s)
postoperative pain.
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Local infiltration
Other Intervention Name(s)
Local wound infiltration
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain scores by coughing between TAP block group and placebo group
Description
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative
Time Frame
0,2,4,6,8,19 and 24 hours postoperative
Secondary Outcome Measure Information:
Title
Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.
Description
Area under the curve (AUC)-pain during cough based on measurements 0,2,4,6,8,19,24 hours postoperative.
Time Frame
0,2,4,6,8,19 and 24 hours postoperative
Title
Total opioid consumption
Description
Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.
Time Frame
0-24 hours postoperative
Title
Postoperative nausea and vomiting
Description
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.
Time Frame
0,2,4,6,8,19,24 hours postoperative
Title
Sedation
Description
Levels of sedation (0-3)at 0,2,4,6,8,19,24 hours postoperative.
Time Frame
0,2,4,6,8,19,24 hours postoperative
Title
Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo
Description
Area under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative
Time Frame
0,2,4,6,8,19,24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille L Petersen, MD
Organizational Affiliation
Glostrup University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesiology, Glostrup university hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23549122
Citation
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.
Results Reference
derived

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The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

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