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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12605000750684
Ethics application status
Approved
Date submitted
9/11/2005
Date registered
17/11/2005
Date last updated
17/11/2005
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled observer blinded trial comparing a standard technique with an ultrasound technique for axillary blockade in teaching hospitals
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Scientific title
A randomised controlled observer blinded trial comparing a standard technique with an ultrasound technique for axillary blockade in teaching hospitals
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Universal Trial Number (UTN)
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Trial acronym
ULTRA1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SURGICAL
904
0
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Condition category
Condition code
Surgery
971
971
0
0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Ultrasound guided technique for regional anaesthesia
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Intervention code [1]
754
0
Treatment: Devices
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
1291
0
Success rate of regional anaesthesia technique.
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Assessment method [1]
1291
0
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Timepoint [1]
1291
0
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Secondary outcome [1]
2318
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Onset time
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Assessment method [1]
2318
0
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Timepoint [1]
2318
0
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Secondary outcome [2]
2319
0
Efficiency
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Assessment method [2]
2319
0
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Timepoint [2]
2319
0
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Secondary outcome [3]
2320
0
Complications
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Assessment method [3]
2320
0
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Timepoint [3]
2320
0
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Eligibility
Key inclusion criteria
Having surgery for which the regional anaesthesia technique is appropriate.
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Minimum age
18
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient refusal to participate in study or receive regional anaesthesia technique.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation sequence concealed until study intervention assigned, central randomisation by phone/email
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/04/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1068
0
Self funded/Unfunded
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Name [1]
1068
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Address [1]
1068
0
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Country [1]
1068
0
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Primary sponsor type
Hospital
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Name
St Vincents Hospital, Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
930
0
None
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Name [1]
930
0
None
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Address [1]
930
0
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Country [1]
930
0
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
To study if a regional anaesthesia technique (axillary blockade) success rate is improved with an ultrasound guided technique compared to a conventional technique in a teaching hospital
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35940
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Address
35940
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Country
35940
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Phone
35940
0
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Fax
35940
0
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Email
35940
0
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Contact person for public queries
Name
9943
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Dr Michael Barrington
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Address
9943
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Department of Anaesthesia
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
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Country
9943
0
Australia
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Phone
9943
0
+61 3 92882211
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Fax
9943
0
+61 3 92884255
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Email
9943
0
[email protected]
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Contact person for scientific queries
Name
871
0
Dr Michael Barrington
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Address
871
0
Department of Anaesthesia
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
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Country
871
0
Australia
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Phone
871
0
+61 3 92882211
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Fax
871
0
+61 3 92884255
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Email
871
0
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A Randomized Controlled Trial of Ultrasound Versus Nerve Stimulator Guidance for Axillary Brachial Plexus Block.
2016
https://dx.doi.org/10.1097/AAP.0000000000000486
N.B. These documents automatically identified may not have been verified by the study sponsor.
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