Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000366358
Ethics application status
Approved
Date submitted
21/07/2008
Date registered
29/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of arm block injection above and below the collar bone for hand surgery
Scientific title
Speed of Onset of Ultrasound Guided Supraclavicular and Infraclavicular Brachial Plexus Block for Ambulatory Hand Surgery
Secondary ID [1] 635 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand surgery requiring anaesthesia 3429 0
Condition category
Condition code
Anaesthesiology 3584 3584 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infraclavicular block
Infraclavicular (IB) Group
The needle will be advanced just posterior to the axillary artery. Following standard intravascular injection precautions, 30mL of 2% lignocaine will then be injected.

Supraclavicular(SB) Group
The needle will be advanced superficially in a medial direction to just inferior to the brachial plexus cords just lateral to the subclavian artery. Following standard intravascular injection precautions, 30mL of 2% lignocaine will then be injected.

The duration of each procedure is approximately 15 minutes, and the overall intervention approximately 30 minutes.
Intervention code [1] 3159 0
Treatment: Devices
Intervention code [2] 3161 0
Treatment: Surgery
Comparator / control treatment
Infraclavicular block
Control group
Active

Outcomes
Primary outcome [1] 4486 0
Onset time of regional arm block
Timepoint [1] 4486 0
0-30 minutes, after the procedure is completed.
Secondary outcome [1] 7593 0
Success rate for surgical anaesthesia
Timepoint [1] 7593 0
30 minutes, after the procedure is completed.

Eligibility
Key inclusion criteria
Patients requiring anaesthesia for elective minor hand surgery under the care of the principal investigator
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent
2. Allergy amide LA drugs
3. Existing neurological disorders, neuropathy of the operative extremity
4. Infection at site of needle puncture

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)
Subjects for the study will be recruited from/by:
1. surgeon in his rooms
2. from the operating list
3. by phone call during the week prior to surgery
4. by Participant Information Sheet mailed during the week prior to surgery
Allocation of treatment will be made by randomised number generator to assign the patient to one of the 2 groups. The allocation is concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1046 0
New Zealand
State/province [1] 1046 0
Auckland

Funding & Sponsors
Funding source category [1] 3616 0
Hospital
Name [1] 3616 0
Anaesthesia Research Trust
Country [1] 3616 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 3247 0
None
Name [1] 3247 0
Address [1] 3247 0
Country [1] 3247 0
Secondary sponsor category [2] 3248 0
None
Name [2] 3248 0
Address [2] 3248 0
Country [2] 3248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5663 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5663 0
Private Bag 92 522
Wellesley Street
Auckland
Ethics committee country [1] 5663 0
New Zealand
Date submitted for ethics approval [1] 5663 0
Approval date [1] 5663 0
16/06/2008
Ethics approval number [1] 5663 0
NTX/08/04/025

Summary
Brief summary
To determine whether ultrasound guided supraclavicular block provides more rapid onset of surgical analgesia than infraclavicular block.
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of the supraclavicular block for hand surgery. Increased exposure of the techniques may promote their uptake in this setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28766 0
Address 28766 0
Country 28766 0
Phone 28766 0
Fax 28766 0
Email 28766 0
Contact person for public queries
Name 11923 0
Dr Michael Fredrickson
Address 11923 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11923 0
New Zealand
Phone 11923 0
0064 9 522 1117
Fax 11923 0
0064 9 522 1127
Email 11923 0
aiservice@xtra.co.nz
Contact person for scientific queries
Name 2851 0
Dr Michael Fredrickson
Address 2851 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 2851 0
New Zealand
Phone 2851 0
0064 9 522 1117
Fax 2851 0
0064 9 522 1127
Email 2851 0
aiservice@xtra.co.nz

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
No additional documents have been identified.