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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Paravertebral anesthesia technique; Procedure: Serratus anesthesia technique

• Registration Number: NCT04983836
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-30
• Study Start: 2021-12-05
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral Block	Paravertebral anesthesia technique	-
Serratus Block	Serratus anesthesia technique	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Walking test	24 hours after the surgery	Improvement of walking distance during the test at 6 min post-operative

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, Toutes, France