Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study (BSBP)

Study Overview
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Brief Summary
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Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.

Official Title
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Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Serratus anesthesia technique
* Procedure: Paravertebral anesthesia technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patient who has given their free, informed and signed consent Social security affiliation; Exclusion Criteria: pregnant woman guardianship / curatorship / private patient under public law surgery to be performed urgently (less than 24 hours) surgery redux thoracotomy surgery sternotomy surgery pleurectomy patient participating simultaneously in another research that may interfere with results of the study severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%). Prior use of morphine; chronic pain/chest neuropathies sepsis patients with insulin-dependent diabetes and/or diabetic neuropathy. severe kidney or liver failure.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, comparative, monocentric, randomized non-inferiority interventional study, in double-blind.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus Block<br> | Procedure: Serratus anesthesia technique<br>* locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml<br>|
| Other: Paravertebral Block<br> | Procedure: Paravertebral anesthesia technique<br>* Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation | Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10) | 48 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking test | Improvement of walking distance during the test at 6 min post-operative | 24 hours after the surgery | 
| Post operative morphine dose Post operative administrated morphin dose | Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg). | 48 hours after the surgery | 
| Morphine side effect quantification | Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression) | 48 hours after the surgery | 
| Length of hospitalisation duration | Number of hospitalisation days | 1 year |