Clinical Trial: Diagnosis of Diaphragmatic Paralysis After Interscalene Block: Feasibility and Impact Observed

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Diagnosis of Diaphragmatic Paralysis After Interscalene Block by Measuring the Inspiratory Diaphragmatic Thickening: Feasibility and Impact Observed

Brief Summary:

1. INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact is mostly absent and paralysis regresses after the block lifted. When it is suspected, it can be diagnosed by a chest radio, showing an elevation of the dome.

   The objective of this study is to evaluate the incidence of diaphragmatic paralysis by measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for the block under ultrasound scan.

2. STUDY TYPE Prospective, single-center clinical study routine care involving 50 consecutive patients scheduled to undergo surgical procedures in the area of the shoulder or arm for which locoregional analgesia inter-block type scalénique or supraclavicular ultrasound scan is indicated below.
3. START OF THE STUDY February 2014 with an expected duration of six months.

Detailed Summary:

1. TITLE OF STUDY

   Diagnosis of diaphragmatic paralysis after interscalene block by measuring the inspiratory diaphragmatic thickening incidence and observed clinical consequences.

2. OBJECTIVES OF THE STUDY

   2.1 Primary Objective: To evaluate the incidence and clinical impact of diaphragmatic paralysis after interscalene block under ultrasound.

   To evaluate the clinical consequences of this paralysis. Quantify diaphragmatic paralysis: paralysis if present is it always complete.

   2.2 Secondary objective: Assess the feasibility of measuring the diaphragmatic thickening as a means simple diagnostics, rapid, non-invasive and non-irradiating bedside by the anesthetist in charge of the patient with the conventional ultrasound equipment available in the operating room without staff intervention Outdoor (radio manipulator, radiologist).

3. STUDY TYPE

   Single-center prospective study in routine care involving 50 consecutive patients conducted from February 2014 for 6 months.

4. LOCATION OF THE STUDY

   The study will take place in recovery and in the operating theater of the hospital Saint Joseph 185 Rue Raymond Losserand 75014 Paris.

   The information and the collection of patient consent will be held in pre-anesthetic visit.

5. RUNNING
   Sponsor: Groupe Hospitalier Paris Saint Joseph
   

   Current Primary Outcome: Diaphragmatic thickening on deep inspiration and expiration in supine position. The fraction is estimated by percentage [ Time Frame: The measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes. ]
   
   

   Original Primary Outcome: Same as current
   
   

   Current Secondary Outcome:
   
   

   Original Secondary Outcome:
   
   Information By: Groupe Hospitalier Paris Saint Joseph
   

   Dates:
   Date Received: August 26, 2015
   Date Started: June 1, 2014
   Date Completion:
   Last Updated: March 6, 2017
   Last Verified: August 2015