Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

Completed

• Conditions: Analgesia; Dyspnea; Hypoxia
• Interventions: Procedure: diaphragmatic assessment using ultrasounds.

• Registration Number: NCT03192865
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-10-01
• Primary Completion: 2014-10-02
• Study Completion: 2015-10-30
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diaphragmatic paralysis/paresis group	diaphragmatic assessment using ultrasounds.	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.
No diaphragmatic paralysis/paresis group	diaphragmatic assessment using ultrasounds.	Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis.

Primary Outcome Measures

Name	Time	Method
Failure of outpatient arthroscopic shoulder surgery strategy	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

Name	Time	Method
Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis	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

Trial Locations

Locations (1)

Clinique Medipole Garonne; 🇫🇷 Toulouse, France