Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

NCT ID: NCT03192865

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-01

Study Completion Date

2015-10-30

Brief Summary

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This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².

Detailed Description

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This prospective observational study will screen patients with body mass index (BMI) ≥30 kg/m² undergoing acromioplasty or supraspinatus tendon repair. Occurrence of post-operative hemidiaphragmatic paralysis will be observed using M-mode ultrasonography and its consequences on patient ventilation: arterial oxygen saturation, dyspnea, success of ambulatory procedure. Causes of diaphragmatic paralysis will be analyzed.

Conditions

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Dyspnea Hypoxia Analgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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diaphragmatic paralysis/paresis group

Diaphragmatic paralysis can be associated with regional anesthesia procedure in arthroscopic shoulder surgery as phrenic nerve is close to the brachial plexus.

Diaphragmatic paralysis will be defined using ultrasounds.

diaphragmatic assessment using ultrasounds.

Intervention Type PROCEDURE

A diaphragmatic assessment will be performed using ultrasound. This is a pain free assessment. This assessment is commun in our unit after arthroscopic shoulder surgery.

No diaphragmatic paralysis/paresis group

Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis.

diaphragmatic assessment using ultrasounds.

Intervention Type PROCEDURE

A diaphragmatic assessment will be performed using ultrasound. This is a pain free assessment. This assessment is commun in our unit after arthroscopic shoulder surgery.

Interventions

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diaphragmatic assessment using ultrasounds.

A diaphragmatic assessment will be performed using ultrasound. This is a pain free assessment. This assessment is commun in our unit after arthroscopic shoulder surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Exclusion Criteria

age \<18 years, brachial plexus neuropathies, severe bronchopulmonary disease, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medications of the study protocol and diabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Medipole Garonne

OTHER

Sponsor Role lead

Responsible Party

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Dr Marty Philippe

Dr Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique Medipole Garonne

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2014-202

Identifier Type: -

Identifier Source: org_study_id

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