A Diaphragm-Sparing Nerve Block for Arthroscopic Shoulder Surgery?
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|ClinicalTrials.gov Identifier: NCT03195426|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Regional Anesthesia Morbidity||Procedure: distal nerves blocks group Procedure: Diaphragmatic function assessment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study aims at assessing the effectiveness of combined SSNB, ICB and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective was to test the hypothesis that SSNB-ICB-SCNB combination could spare phrenic nerve.|
|Masking:||None (Open Label)|
|Official Title:||Is There a Real Diaphragm-Sparing Nerve Block for Arthroscopic Shoulder Surgery?|
|Actual Study Start Date :||June 20, 2017|
|Actual Primary Completion Date :||June 22, 2017|
|Actual Study Completion Date :||July 10, 2017|
Experimental: distal nerves blocks group
This study aims at assessing the effectiveness of combined supra scapular nerve block, infraclavicular block and supraclavicular nerve block as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery.
These blocks are performed for decades in routine care. The originality of this study is to analyze the combination of these different blocks for post-operative pain relief in arthroscopic shoulder surgery. This combination can be considered as an alternative to interscalene block well known to be associated with diaphragmatic paralysis.
Local anesthetics used in this study are used for many years in routine care: Ropivacaine 0.375%. A single injection will be performed under ultrasounds. No continuous injection will be performed.
Procedure: distal nerves blocks group
Procedure: Diaphragmatic function assessment
Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
This a pain free and safe procedure, that we usually perform in patients at risk of respiratory failure.
- success of regional anesthesia procedure (no requirement of intraoperative general anethesia) [ Time Frame: 12 hours ]
The primary outcome is the success rate of regional anesthesia (i.e. intraoperative conversion to general anesthesia was considered as a regional anesthesia failure).
General anesthesia was defined as requirement of intraoperative invasive ventilation.
- diaphragmatic paralysis [ Time Frame: 12 hours ]The secondary outcomes is the analysis of diaphragmatic paralysis. Complete hemi diaphragmatic paralysis was defined as a greater than 75% reduction in diaphragmatic excursion measured in the Voluntary Sniff test. Partial paralysis was defined as a 25% to 75% reduction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195426
|Clinique Medipole Garonne|
|Toulouse, France, 31036|