The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine

NCT ID: NCT02055664

Last Updated: 2019-05-06

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-23

Brief Summary

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This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.

Detailed Description

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Conditions

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Elective Surgery of the Spine by Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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treatment

Group Type EXPERIMENTAL

Chlorure de sodium 0.9%

Intervention Type DRUG

control

Group Type PLACEBO_COMPARATOR

Ropivacaine 0.2%

Intervention Type DRUG

Interventions

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Ropivacaine 0.2%

Intervention Type DRUG

Chlorure de sodium 0.9%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 yo who have provided written informed consent
* Patients with an indication for elective spinal surgery using laparotomy
* Patients with national health insurance cover

Exclusion Criteria

* Adults under guardianship
* Pregnant or breast-feeding women
* allergies or contra-indication for paracetamol, morphine-based drugs
* Contra-indication for ropivacaine
* Contra-indication for sodium chloride
* inability to understand PCA (patient-controlled anaesthesia)
* Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
* Hypovolemia
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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MIREK 2013

Identifier Type: -

Identifier Source: org_study_id

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