Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

Study Overview
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Brief Summary
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osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is usually considered as the gold standard for postoperative thoracic analgesia. Unfortunately, it's not always possible to realize it because of contraindications or because of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it provides an unilateral sensitive and sympathetic block using a catheter.In our study, the catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under direct vision, to insure maximal security also on patients on antiplatelets agents, anticoagulants or with haemostasis disorders (the placement of the catheter by the anaesthetist with the loss of resistance technique is contraindicated in these cases).Patients will be randomized to receive either a continuous 48-hours infusion of ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic scale (VAS) at rest and on movement, total morphine consumption and side effects will be recorded during the first 48 hours after surgery. The aim of this study is to prove a decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation, bradypnea, urinary retention).

Official Title
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Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia : Paravertebral Analgesia With a Catheter Associated With Intravenous Morphine Patient-controlled-analgesia (Pca)

Conditions
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Pain

Intervention / Treatment
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* Drug: ropivacaine
* Other: nacl 0,9%


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 auriculae-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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ropivacaine 0.5% 0.1 ml/kg per hour | Drug: ropivacaine<br>* Ropivacaine 0.5% 0.1 ml/kg per hour<br>|
| Placebo Comparator: 2<br> | Other: nacl 0,9%<br>* saline 0.9% 0.1 ml/kg per hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | first 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| · Total dosis of morphine consumption, side effects nausea, vomiting,pruritus,Urinary retention, respiratory rate and sedation, · heart rate, blood pressure and peripheral saturation |  | first 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, Contraindications, Paravertebral nerve block analgesia, ropivacaine, Visual analogical scale, Morphine, Side effects, Pain and thoracotomy