Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.

Study Overview
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Brief Summary
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The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.

Official Title
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Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine + Sufentanil
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for planned video-assisted thoracic surgery Patient that consent to participate Planned placement of paravertebral catheter Patient having a medical insurance Exclusion Criteria: Patient less than 18 years Refusal to participate Known pregnancy Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material Intolerance to sufentanil and/or morphine Chronic consumption of opiates Preoperative chronic pain syndrome Patient having a contraindication to placement of paravertebrtal catheter

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 |
| --- | --- |
| Active Comparator: Continuous paravertebral block with ropivacaine<br> | Drug: Ropivacaine<br>* Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours<br>|
| Experimental: Continuous paravertebral block with ropivacaine and sufentanil<br> | Drug: Ropivacaine + Sufentanil<br>* Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption during the first 48 hours |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute pain | using the Visual Analogue Scale (VAS) score | 48 hours | 
| Biological measurements | Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate | 48 hours | 
| Patient satisfaction |  | 48 hours | 
| Chronic pain | assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire. | 3 and 6 monthes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paravertebral Block, Regional Anesthesia, Anesthetics Local, Ropivacaine, Sufentanil, Pain Postoperative, Chronic Pain, Thoracic Surgery Video-Assisted.