NCT03842423

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
16.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

16.8 years

First QC Date

February 13, 2019

Last Update Submit

February 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Conversion to general anaesthesia

    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.

    intraoperatively

Study Arms (1)

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.

Procedure: Brachial Plexus Anaesthesia

Interventions

Regional anaesthesia for treatment of upper extremity injuries.

Study Group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Brachial plexus anaesthesia for surgical intervention of upper extremity injuries

You may not qualify if:

  • age above 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1210, Austria

Location

Related Publications (1)

  • Zadrazil M, Opfermann P, Marhofer P, Westerlund AI, Haider T. Brachial plexus block with ultrasound guidance for upper-limb trauma surgery in children: a retrospective cohort study of 565 cases. Br J Anaesth. 2020 Jul;125(1):104-109. doi: 10.1016/j.bja.2020.03.012. Epub 2020 Apr 24.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 15, 2019

Study Start

January 1, 2002

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations