Upper Extremity FractureNCT03842423
Brachial Plexus Block in Children and Adolescents
An observational study of Upper Extremity Fracture, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Upper Extremity Fracture
- What is being tested?
- Brachial Plexus Anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 2,760 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2002to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under the age of 18 who sustained an injury of the upper extremity requiring surgery and received brachial plexus anaesthesia.
Who may be able to join
- Brachial plexus anaesthesia for surgical intervention of upper extremity injuries
Who cannot join
- age above 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Upper Extremity Fracture
- Being tested
- Brachial Plexus Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial Plexus AnaesthesiaProcedure or surgery
Regional anaesthesia for treatment of upper extremity injuries.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Brachial Plexus Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2002
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity FractureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Haider, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842423
- Sponsor's protocol ID
- 2090/2018
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32340734
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachial Plexus Block in Children and Adolescents Requiring Surgery Following Trauma
- ClinicalTrials.gov ID
- NCT03842423
- Acronym / sponsor ID
- 2090/2018
- Conditions
- Upper Extremity Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,760 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: Brachial Plexus AnaesthesiaAll patients under the age of 18 who were treated for upper extremity injuries between 2002 and 2018 and receiving brachial plexus anaesthesia. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under the age of 18 who sustained an injury of the upper extremity requiring surgery and received brachial plexus anaesthesia.
Key inclusion criteria (1 listed)
- Brachial plexus anaesthesia for surgical intervention of upper extremity injuries
Key exclusion criteria (1 listed)
- age above 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachial Plexus AnaesthesiaRegional anaesthesia for treatment of upper extremity injuries. | Procedure or surgery | Study Group |
Primary outcome
Conversion to general anaesthesia
Time frame: intraoperatively
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32340734Zadrazil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Fracture, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to general anaesthesia (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.