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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
University Hospital, Departement of Anesthesia and Intensive Care
Grenoble, Auvergne-Rhône-Alpes, France
morphine consumption
Time frame: 48 hours after surgery
number of patients in need of morphine in post surgery monitoring room
Time frame: 1 hour after surgery
morphine consumption in post surgery monitoring room
Time frame: 1 hour post surgery
consumption of morphine
Time frame: 72 hours after surgery
global self appreciation of pain management
Time frame: at 72 hours
Time required for post surgery functional recovery
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Adverse effects of morphine
Time frame: 72 hours after surgery
hospitalization delay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
asked bolus divided by delivered bolus
Time frame: until 72 hours after surgery
Score for pain intensity
Time frame: until 72 hours after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.