- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03192865
Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery
Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31036
- Clinique Médipôle Garonne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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. |
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
the first 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
the first 2 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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