Text Size

The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01052285
First received: January 19, 2010
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hernia
 Procedure: Transversus abdominis plane block
Procedure: Saline
Procedure: Local infiltration
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Pain scores by coughing between TAP block group and placebo group [ Time Frame: 0,2,4,6,8,19 and 24 hours postoperative ] [ Designated as safety issue: No ]
    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. [ Time Frame: 0,2,4,6,8,19 and 24 hours postoperative ] [ Designated as safety issue: No ]
    Area under the curve (AUC)-pain during cough based on measurements 0,2,4,6,8,19,24 hours postoperative.

  • Total opioid consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.

  • Postoperative nausea and vomiting [ Time Frame: 0,2,4,6,8,19,24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0,2,4,6,8,19,24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0,2,4,6,8,19,24 hours postoperative ] [ Designated as safety issue: No ]
    Area under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative


Enrollment: 90
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.
 Procedure: 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
Other Name: postoperative pain.
Active Comparator: 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
 Procedure: 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
Other Name: Local wound infiltration
Experimental: Transversus abdominis plane block
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
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
Other Name: postoperative pain, UL-guided block

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052285

Locations
Denmark
Department of Anaesthesiology, Glostrup university hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Pernille L Petersen, MD Glostrup University Hospital
  More Information

No publications provided

Responsible Party: Pernille Lykke Petersen, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01052285     History of Changes
Other Study ID Numbers: SM1-plp-10, 2010-018403-29
Study First Received: January 19, 2010
Last Updated: November 17, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Glostrup University Hospital, Copenhagen:
Transversus abdominis plane block

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013