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

NCT ID: NCT04983836

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-05
• Study Completion Date: 2022-12-15

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Serratus Block

Group Type: EXPERIMENTAL

Serratus anesthesia technique

Intervention Type: PROCEDURE

locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml

Paravertebral Block

Group Type: OTHER

Paravertebral anesthesia technique

Intervention Type: PROCEDURE

Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine

Interventions

Serratus anesthesia technique

locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml

Intervention Type: PROCEDURE

Paravertebral anesthesia technique

Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de NICE

Nice, Toutes, France

Countries

France

Other Identifiers

19-AOI-04

Identifier Type: -

Identifier Source: org_study_id