Continuous Wound Infusion in Lumbar or Thoracic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Lumbar Spine Surgery, Thoracic Spine Surgery

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline solution 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults > 18 years Physical status score I, II or III (American Society of Anesthesiologists) lumbar or thoracic spine surgery with arthrodesis through posterior only approach signed informed consent beneficiary of social security Exclusion Criteria: vulnerable persons according to law scoliosis surgery local anesthetic allergia contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol long term anti platelet aggregants inability to comply to protocol requirements psychiatric disorders or cognitive disabilities chronic pain or long term opioids consumption diabetes obesity (BMI > 30) pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine 0.2%, wound infusion<br> | Drug: Ropivacaine<br>* wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion<br>|
| Placebo Comparator: saline solution 0.9%, wound infusion<br> | Drug: Saline solution 0.9%<br>* wound infusion, 0.9%, bolus 10mL followed by 8 mL/h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption |  | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients in need of morphine in post surgery monitoring room |  | 1 hour after surgery | 
| morphine consumption in post surgery monitoring room |  | 1 hour post surgery | 
| consumption of morphine |  | 72 hours after surgery | 
| global self appreciation of pain management |  | at 72 hours | 
| Time required for post surgery functional recovery |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| Adverse effects of morphine |  | 72 hours after surgery | 
| hospitalization delay |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| asked bolus divided by delivered bolus |  | until 72 hours after surgery | 
| Score for pain intensity |  | until 72 hours after surgery |