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Your journey
1What's a trial
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3Review
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More info
You can access this
clinical trial
if you have
Lumbar Spine Surgery or Thoracic Spine Surgery
and you are
over 18
years old
2
3
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
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The purpose

Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery. Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".

Provided treatments

  • Drug: Ropivacaine
  • Drug: Saline solution 0.9%

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01743794. The sponsor of the trial is University Hospital, Grenoble and it is looking for 60 volunteers for the current phase.
Official trial title:
Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study