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

U

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed
Phase 4

Conditions

Elective Surgery of the Spine by Laparotomy

Treatments

Drug: Ropivacaine 0.2%
Drug: Chlorure de sodium 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT02055664
MIREK 2013

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups, including a placebo group

treatment
Experimental group
Treatment:
Drug: Chlorure de sodium 0.9%
control
Placebo Comparator group
Treatment:
Drug: Ropivacaine 0.2%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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