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

NCT02539173 | Completed DMC

• 1 other identifier: FONCTION DIAPHRAGMATIQUE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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. 3.START OF THE STUDY February 2014 with an expected duration of six months.

Conditions

Shoulder Fractures; Arm Fractures

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic thickening on deep inspiration and expiration in supine position. The fraction is estimated by percentage

  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.

Study Arms (1)

Experimental

EXPERIMENTAL

Ultrasound scan of diaphragm is made preoperatively during the pre-anesthetic visit, patients are informed of the purpose of the study. Written consent is collected after oral and written information.

Other: Ultrasound scan

Interventions

Ultrasound scan OTHER

Non-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach. It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients

You may not qualify if:

• Minor patients

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Belaid BOUHEMAD, Dr

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 2, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 7, 2017

Record last verified: 2015-08

Locations

FR (1)