TAP-Block in Abdominal Aortic Surgery

NCT ID: NCT03657979

Last Updated: 2018-09-05

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-05

Study Completion Date

2012-08-29

Brief Summary

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The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal

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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Ropivacaine

Conventional PCA morphine +TAP-block ropivacaine 0.2%

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

TAP-block Ropivacaine 0.2% during 48 hours

TAP-block with placebo

Conventional PCA morphine treatment with TAP-block with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TAP-block with placebo

Interventions

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Ropivacaine

TAP-block Ropivacaine 0.2% during 48 hours

Intervention Type DRUG

Placebo

TAP-block with placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
* Person who has given his written consent

Exclusion Criteria

* Emergency surgery
* Patient with infection
* Use of opioids in the long term
* History of chronic pain
* Higher functions incompatible with the functioning of the PCA
* Patients under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Eric STEINMETZ

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claude GIRARD, Professor

Role: PRINCIPAL_INVESTIGATOR

Anesthesia unit

Eric STEINMETZ, Professor

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular and thoracic surgery unit

Locations

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Cardiovascular and thoracic surgery unit, CHU Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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2011-002355-34

Identifier Type: -

Identifier Source: org_study_id

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