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Completed

NCT Number: NCT03192865

Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

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

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Key information

Conditions

Dyspnea Agnosia Analgesia Hypoxia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Medipole Garonne

Toulouse, 31036, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diaphragmatic assessment using ultrasounds.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinique Medipole Garonne

Other

Registry information

Official study title

Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2017
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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