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Interscalene Block and Dysfunction Diaphragmatic — NUMEROBIS  

Diaphragmatic Paralysis Clinical Trial

Official title:
Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial

Clinical Trial Summary

The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.

Clinical Trial Description

It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind. the study concerns patients undergoing arthroscopic shoulder surgery with ISB. The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB. Randomization in one of the two arms: - Experimental group: <8ml ropivacaine 0.1%. - Control group: <8mL of ropivacaine 0.5%. Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB. Performing the surgical procedure under general anesthesia assessment of postoperative analgesia and patient satisfaction during the following 48 hours. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04173364
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase Phase 3
Start date October 29, 2019
Completion date September 21, 2020
View Details
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