The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine (TAPBloc Rachis)

May 3, 2019 updated by: Centre Hospitalier Universitaire Dijon

THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Drug: Chlorure de sodium 0.9%
Placebo Comparator: control
Drug: Ropivacaine 0.2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of morphine in mg
Time Frame: First 48 hours following the surgery
First 48 hours following the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain
Time Frame: First 48 hours following the surgery
First 48 hours following the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2014

Primary Completion (Actual)

August 12, 2015

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIREK 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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