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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055664
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Elective Surgery of the Spine by Laparotomy Drug: Ropivacaine 0.2% Drug: Chlorure de sodium 0.9% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: 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
Actual Study Start Date : January 23, 2014
Actual Primary Completion Date : August 12, 2015

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



Primary Outcome Measures :
  1. Consumption of morphine in mg [ Time Frame: First 48 hours following the surgery ]

Secondary Outcome Measures :
  1. Intensity of pain [ Time Frame: First 48 hours following the surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055664


Locations
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France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02055664    
Other Study ID Numbers: MIREK 2013
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents