Trial Review

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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
Scientific title
A randomised controlled observer blinded trial comparing a standard technique with an ultrasound technique for axillary blockade in teaching hospitals
Universal Trial Number (UTN)
Trial acronym
ULTRA1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SURGICAL 904 0
Condition category
Condition code
Surgery 971 971 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided technique for regional anaesthesia
Intervention code [1] 754 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1291 0
Success rate of regional anaesthesia technique.
Timepoint [1] 1291 0
Secondary outcome [1] 2318 0
Onset time
Timepoint [1] 2318 0
Secondary outcome [2] 2319 0
Efficiency
Timepoint [2] 2319 0
Secondary outcome [3] 2320 0
Complications
Timepoint [3] 2320 0

Eligibility
Key inclusion criteria
Having surgery for which the regional anaesthesia technique is appropriate.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal to participate in study or receive regional anaesthesia technique.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation sequence concealed until study intervention assigned, central randomisation by phone/email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1068 0
Self funded/Unfunded
Name [1] 1068 0
Country [1] 1068 0
Primary sponsor type
Hospital
Name
St Vincents Hospital, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 930 0
None
Name [1] 930 0
None
Address [1] 930 0
Country [1] 930 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35940 0
Address 35940 0
Country 35940 0
Phone 35940 0
Fax 35940 0
Email 35940 0
Contact person for public queries
Name 9943 0
Dr Michael Barrington
Address 9943 0
Department of Anaesthesia
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
Country 9943 0
Australia
Phone 9943 0
+61 3 92882211
Fax 9943 0
+61 3 92884255
Email 9943 0
michael.barrington@svhm.org.au
Contact person for scientific queries
Name 871 0
Dr Michael Barrington
Address 871 0
Department of Anaesthesia
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
Country 871 0
Australia
Phone 871 0
+61 3 92882211
Fax 871 0
+61 3 92884255
Email 871 0
michael.barrington@svhm.org.au

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
SourceTitleYear of PublicationDOI
EmbaseA Randomized Controlled Trial of Ultrasound Versus Nerve Stimulator Guidance for Axillary Brachial Plexus Block.2016https://dx.doi.org/10.1097/AAP.0000000000000486
N.B. These documents automatically identified may not have been verified by the study sponsor.