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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
Sponsor:
Information provided by (Responsible Party):
Dr Marty Philippe, Clinique Medipole Garonne

Brief Summary:
This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB), infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic nerve.

Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Procedure: distal nerves blocks group Procedure: Diaphragmatic function assessment Not Applicable

  Show Detailed Description

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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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
  • ICB: US probe will be placed just below clavicle inferior to site of needle entry. Following identification of axillary artery and cords, the needle will be advanced posterior to axillary artery. 20 cc of Ropivacaine 0.375% will then be deposited in a U-shaped distribution posterior and to each side of the axillary artery.
  • SSNB will be performed by locating the brachial plexus and the departure of the suprascapular nerve from the superior trunk under the inferior belly of the omohyoid muscle by sliding the transducer distally and then injecting 5 mL of ropivacaine 0.375%.
  • SCNB will be performed injecting 5 mL of ropivacaine 0.375% in the intermuscular plane between the sternocleidomastoid and scalene muscles using a lateral to medial in-plane technique.

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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Exclusion Criteria:

  • Exclusion criteria are: age <18 years, brachial plexus neuropathies, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medication of the study protocol and diabetes.

Information from the National Library of Medicine

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


Locations
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France
Clinique Medipole Garonne
Toulouse, France, 31036
Sponsors and Collaborators
Clinique Medipole Garonne

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Responsible Party: Dr Marty Philippe, Clinique Medipole Garonne
ClinicalTrials.gov Identifier: NCT03195426     History of Changes
Other Study ID Numbers: 2016-202
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents