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OpenTrials
Completed

NCT Number: NCT02055664

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

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.

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Key information

Conditions

Elective Surgery of the Spine by Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.2%

Drug

Chlorure de sodium 0.9%

Drug

Primary outcomes

  1. Consumption of morphine in mg

    Time frame: First 48 hours following the surgery

Secondary outcomes

  1. Intensity of pain

    Time frame: First 48 hours following the surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: TAPBloc Rachis

Important dates

Study start
2014
Primary completion
2015
First posted
Feb 5, 2014
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.