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The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052285
First Posted: January 20, 2010
Last Update Posted: November 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Pernille Lykke Petersen, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Submitted: January 19, 2010
First Posted: January 20, 2010
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Pernille Lykke Petersen, 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
Sensory System Agents
Peripheral Nervous System Agents