Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

July 10, 2017 updated by: Dr Marty Philippe, Clinique Medipole Garonne

Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31036
        • Clinique Médipôle Garonne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Interscalene block with high volume of local anesthetics
  • Interscalene block with low volume of local anesthetics
  • distal block
the first 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 2, 2014

Study Completion (Actual)

October 30, 2015

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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