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NCT03192865 Clinical Trial

Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

Analgesia Clinical Trial

Official title:
Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03192865
Other study ID # 2014-202
Secondary ID
Status Completed
Phase N/A
First received June 16, 2017
Last updated July 10, 2017
Start date October 1, 2014
Est. completion date October 30, 2015

Study information
Verified date July 2017
Source Clinique Medipole Garonne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 30, 2015
Est. primary completion date October 2, 2014
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Clinique Medipole Garonne Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Clinique Medipole Garonne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure of outpatient arthroscopic shoulder surgery strategy failure of outpatient arthroscopic shoulder surgery strategy is communly associated with dyspnea or hypoxia due to diaphragmatic paralysis the first 6 hours
Secondary Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis 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		 the first 2 hours
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