- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842423
Brachial Plexus Block in Children and Adolescents
February 13, 2019 updated by: Thomas Haider, Medical University of Vienna
Brachial Plexus Block in Children and Adolescents Requiring Surgery Following Trauma
This study involves a retrospective evaluation of brachial plexus anaesthesia in children and adolescents (patients under the age of 18) undergoing surgical procedures of the upper extremity following trauma.
The investigators plan to recruit patients from our hospital patient database meeting our inclusion criteria.
Observational period was defined between 1st of January 2002 and 31st of October 2018.
Necessity to convert to general anaesthesia was defined as primary endpoint.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2760
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
-
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Vienna, Austria, 1210
- Medical University of Vienna
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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
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients under the age of 18 who sustained an injury of the upper extremity requiring surgery and received brachial plexus anaesthesia.
Description
Inclusion Criteria:
- Brachial plexus anaesthesia for surgical intervention of upper extremity injuries
Exclusion Criteria:
- age above 18
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 |
---|---|
Study Group
All patients under the age of 18 who were treated for upper extremity injuries between 2002 and 2018 and receiving brachial plexus anaesthesia.
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Regional anaesthesia for treatment of upper extremity injuries.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion to general anaesthesia
Time Frame: intraoperatively
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The necessity to convert to general anaesthesia will be obtained from surgery and anaesthesiology protocols and serves as primary outcome to evaluate efficacy of the investigated method of anaesthesia.
All patients who received plexus brachialis anaesthesia but had to be converted to general anaesthesia during or prior the surgical intervention will assigned to this outcome measurement.
Number of patients who required conversion will be given as percentage of total patient collective.
Possible variables: e.g.
0=no conversion, 1=conversion.
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intraoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
January 1, 2002
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
February 13, 2019
First Submitted That Met QC Criteria
February 13, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2090/2018
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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