Clinical trial NCT04983836: Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study (BSBP)
Official title: Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, comparative, monocentric, randomized non-inferiority interventional study, in double-blind.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain evaluation
timeFrame: 48 hours after the surgery
Secondary outcomes:
measure: Walking test
timeFrame: 24 hours after the surgery
measure: Post operative morphine dose Post operative administrated morphin dose
timeFrame: 48 hours after the surgery
measure: Morphine side effect quantification
timeFrame: 48 hours after the surgery
measure: Length of hospitalisation duration
timeFrame: 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
state: Toutes
Study officials:
References: