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Transversus Abdominis Plane Block During Kidney Transplant Surgery

NCT ID: NCT02080728

Last Updated: 2018-12-21

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

2013-07-23

Study Completion Date

2014-07-09

Brief Summary

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The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.

This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.

This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.

Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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TAP-Bloc

Group Type EXPERIMENTAL

Ropivacaine 500mg/100ml Naropeine

Intervention Type DRUG

Control

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride BAXTER

Intervention Type DRUG

Interventions

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Ropivacaine 500mg/100ml Naropeine

Intervention Type DRUG

0.9% sodium chloride BAXTER

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient opéré for kidney transplant
* Patients who have provided written informed consent
* Patients with national health insurance cover
* Patients aged 18 years and above

Exclusion Criteria

* Pregnant or breast-feeding women
* allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
* patients under guardianship or ward of court
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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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Jazayeri-Steinmetz AOI 2012

Identifier Type: -

Identifier Source: org_study_id