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The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01052285
Enrollment
90
Registered
2010-01-20
Start date
2010-06-30
Completion date
2011-11-30
Last updated
2011-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia

Keywords

Transversus abdominis plane block

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.

Interventions

PROCEDURETransversus 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

PROCEDURESaline

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

PROCEDURELocal 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

Sponsors

Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scores by coughing between TAP block group and placebo group0,2,4,6,8,19 and 24 hours postoperativeArea under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative

Secondary

MeasureTime frameDescription
Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.0,2,4,6,8,19 and 24 hours postoperativeArea under the curve (AUC)-pain during cough based on measurements 0,2,4,6,8,19,24 hours postoperative.
Total opioid consumption0-24 hours postoperativeTotal morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.
Postoperative nausea and vomiting0,2,4,6,8,19,24 hours postoperativeLevels 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.
Sedation0,2,4,6,8,19,24 hours postoperativeLevels 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 placebo0,2,4,6,8,19,24 hours postoperativeArea under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026