Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study (BSBP)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Serratus Block
|
Procedure: Serratus anesthesia technique
locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml
|
| Other: Paravertebral Block
|
Procedure: Paravertebral anesthesia technique
Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine
|
Outcome Measures
Primary Outcome Measures
- Pain evaluation [48 hours after the surgery]
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)
Secondary Outcome Measures
- Walking test [24 hours after the surgery]
Improvement of walking distance during the test at 6 min post-operative
- Post operative morphine dose Post operative administrated morphin dose [48 hours after the surgery]
Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg).
- Morphine side effect quantification [48 hours after the surgery]
Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression)
- Length of hospitalisation duration [1 year]
Number of hospitalisation days
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18 years
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Patient who has given their free, informed and signed consent
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Social security affiliation;
Exclusion Criteria:
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pregnant woman
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guardianship / curatorship / private patient under public law
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surgery to be performed urgently (less than 24 hours)
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surgery redux
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thoracotomy surgery
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sternotomy surgery
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pleurectomy
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patient participating simultaneously in another research that may interfere with results of the study
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severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%).
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Prior use of morphine;
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chronic pain/chest neuropathies
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sepsis
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patients with insulin-dependent diabetes and/or diabetic neuropathy.
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severe kidney or liver failure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de NICE | Nice | Toutes | France | 06000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-AOI-04