Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

Study Overview
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Brief Summary
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Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.

Official Title
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Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)

Conditions
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Pain, Thoracotomy

Intervention / Treatment
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* Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
* Drug: Placebo
* Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for thoracotomy who presented with contraindications to TEA. Contraindications to TEA are : Patient's refusal after informations about advantages and risks of the technique Anti platelets treatment that can't be discontinued Anticoagulants at a curative dosage haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75% Systemic or local infection of the puncture point 2 and 3 grade atrio-ventricular heart block without pacing Severe aortic valve stenosis Kyphoscoliosis certain neurological disorders Exclusion Criteria: Patient's refusal to participate in the study Psychiatric disorder (impossibility to collect the informed consent) Patient under juridical protection On going an other study Pregnancy, breastfeeding Non balanced epilepsy 3 grade auriculo-ventricular heart block without pacing Severe hepatocellular insufficiency Anti arrhythmic treatment : class III of the Vaughan William's classification Skin infection of the puncture point Allergy to aminoamides local anaesthetic Surgical difficulties to insert paravertebral catheter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br> | Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)<br>* The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.<br>Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)<br>* The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intravenous morphine consumption (mg) |  | the first 48 hours after surgery |