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

NCT04983836 | Completed

• 1 other identifier: 19-AOI-04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Walking test

  24 hours after the surgery

• Post operative morphine dose Post operative administrated morphin dose

  48 hours after the surgery

• Morphine side effect quantification

  48 hours after the surgery

• Length of hospitalisation duration

  1 year

Study Arms (2)

Serratus Block

EXPERIMENTAL

Procedure: Serratus anesthesia technique

Paravertebral Block

OTHER

Procedure: Paravertebral anesthesia technique

Interventions

Serratus anesthesia technique PROCEDURE

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

Serratus Block

Paravertebral anesthesia technique PROCEDURE

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

Paravertebral Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patient who has given their free, informed and signed consent
• Social security affiliation;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, Toutes, 06000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, comparative, monocentric, randomized non-inferiority interventional study, in double-blind.

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 30, 2021
• Study Start: December 5, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)