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Completed

NCT Number: NCT01052285

The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

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.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology, Glostrup university hospital

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversus abdominis plane block

Procedure

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 names: postoperative pain, UL-guided block

Saline

Procedure

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 names: postoperative pain.

local infiltration

Procedure

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 names: Local wound infiltration

Primary outcomes

  1. 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

  1. 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.

  2. Total opioid consumption

    Time frame: 0-24 hours postoperative

    Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2010
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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