NCT01743794

Continuous Wound Infusion in Lumbar or Thoracic Surgery

Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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".

Conditions

• Lumbar Spine Surgery
• Thoracic Spine Surgery

Interventions

Type	Name	Description
DRUG	Ropivacaine	wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
DRUG	Saline solution 0.9%	wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-01-01
• Completion: 2012-07-01
• First posted: 2012-12-06
• Last updated: 2012-12-06

Locations

1 site across 1 country: France