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Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03192865
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Marty Philippe, Clinique Medipole Garonne

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

Condition or disease Intervention/treatment
Dyspnea Hypoxia Analgesia Procedure: diaphragmatic assessment using ultrasounds.

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : October 2, 2014
Actual Study Completion Date : October 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Group/Cohort Intervention/treatment
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.

Procedure: 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.

No diaphragmatic paralysis/paresis group
Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis.
Procedure: 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.




Primary Outcome Measures :
  1. Failure of outpatient arthroscopic shoulder surgery strategy [ Time Frame: the first 6 hours ]
    failure of outpatient arthroscopic shoulder surgery strategy is communly associated with dyspnea or hypoxia due to diaphragmatic paralysis


Secondary Outcome Measures :
  1. Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis [ Time Frame: the first 2 hours ]

    Different strategies of peripheral nerve block can be proposed for post-operative pain relief in arthroscopic shoulder surgery.

    All strategies were grouped in 3 parts:

    • Interscalene block with high volume of local anesthetics
    • Interscalene block with low volume of local anesthetics
    • distal block



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
Criteria

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.


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): NCT03192865


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, Dr Anesthesiologist, Clinique Medipole Garonne
ClinicalTrials.gov Identifier: NCT03192865     History of Changes
Other Study ID Numbers: 2014-202
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Dyspnea
Respiratory Paralysis
Paralysis
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Respiratory Insufficiency