The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

NCT ID: NCT01052285

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia

Keywords

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Transversus abdominis plane block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Local infiltration

Intervention Type 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

Transversus abdominis plane block

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

Group Type EXPERIMENTAL

Transversus abdominis plane block

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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postoperative pain, UL-guided block postoperative pain. Local wound infiltration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Pernille Lykke Petersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernille L Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital

Locations

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Department of Anaesthesiology, Glostrup university hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23549122 (View on PubMed)

Other Identifiers

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2010-018403-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM1-plp-10

Identifier Type: -

Identifier Source: org_study_id