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

Anesthesia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983836
• Other study ID #: 19-AOI-04
• Status: Completed
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Serratus anesthesia technique
locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml
• Paravertebral anesthesia technique
Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine

Locations

Country	Name	City	State
France	CHU de NICE	Nice	Toutes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Walking test	Improvement of walking distance during the test at 6 min post-operative	24 hours after the surgery
Secondary	Post operative morphine dose Post operative administrated morphin dose	Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg).	48 hours after the surgery
Secondary	Morphine side effect quantification	Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression)	48 hours after the surgery
Secondary	Length of hospitalisation duration	Number of hospitalisation days	1 year