Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000318280
Ethics application status
Approved
Date submitted
29/03/2009
Date registered
21/05/2009
Date last updated
13/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the success of Single vs Triple Injection for Ultrasound Guided Infraclavicular Block in patients undergoing wrist and forearm surgery
Scientific title
Optimising Ultrasound Guided Infraclavicular Brachial Plexus Block for Ambulatory Hand Surgery: single vs. triple point injection
Secondary ID [1] 259924 0
Hand09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical anaesthesia during minor wrist and hand surgery 4533 0
Condition category
Condition code
Anaesthesiology 4821 4821 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single point injection (deep to axillary artery) for ultrasound guided infraclavicular block with 30 mL lignicaine 2%, one-off treatment lasting 10 minutes, used in conjunction with ultrasound machine and transducer.
Intervention code [1] 4292 0
Treatment: Drugs
Comparator / control treatment
Triple point injection (around the 3 cords of the brachial plexus) for ultrasound guided infraclavicular block (30 mL lignocaine 2%, one-off treatment lasting 10 minutes, used in conjunction with Ultrasound machine and transducer
Control group
Active

Outcomes
Primary outcome [1] 5681 0
Block effectiveness after ultrasound guided infraclavicular block assessed by pin-prick sensation in the 4 distal nerve territories
Timepoint [1] 5681 0
Immediately prior to and immediately following block placement and at 10 minute intervals until block complete
Secondary outcome [1] 241580 0
Block placement time
Timepoint [1] 241580 0
During block placement
Secondary outcome [2] 241981 0
Surgical Anaesthesia: adequacy of anesthesia to conduct the surgical procedure. It will be assessed by the surgeon based on whether the anaesthesia is satisfactory or not.
Timepoint [2] 241981 0
1-2 hour post procedure
Secondary outcome [3] 241982 0
Procedural pain assessed by direct patient interrogation
Timepoint [3] 241982 0
At 10 minutes after injection

Eligibility
Key inclusion criteria
Patients requiring surgical anaesthesia for minor hand or wrist surgery under the care of the two investigators
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal for brachial plexus block. 2. Known neuropathy involving the arm undergoing surgery. 3. Known allergy to amide local anaesthetic drugs.

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)
Initial invitation to participate in the study will occur in the surgeon's rooms. Approximately one week prior to surgery, patients will be contacted by a research assistant to provide further informed consent. Written informed consent will be obtained from all patients. Assignment of the patient to single point or triple point injection will be delivered in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be used to assign the patient to one of the 2 groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
27/01/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1701 0
New Zealand
State/province [1] 1701 0
Auckland

Funding & Sponsors
Funding source category [1] 4723 0
Self funded/Unfunded
Name [1] 4723 0
Dr Michael Fredrickson
Country [1] 4723 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] 4268 0
None
Name [1] 4268 0
Address [1] 4268 0
Country [1] 4268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6766 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6766 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 6766 0
New Zealand
Date submitted for ethics approval [1] 6766 0
09/03/2009
Approval date [1] 6766 0
21/05/2009
Ethics approval number [1] 6766 0
NTY/09/03/028

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of a single point injection for infraclavicular block. Increased exposure of the techniques may promote their uptake in this setting.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 29441 0
Dr Michael Fredrickson
Address 29441 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 29441 0
New Zealand
Phone 29441 0
+6495221117
Fax 29441 0
Email 29441 0
anaesthesiainstitute@yahoo.com
Contact person for public queries
Name 12688 0
Dr Dr Michael Fredrickson
Address 12688 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 12688 0
New Zealand
Phone 12688 0
+64 9 522 1117
Fax 12688 0
+64 9 522 1127
Email 12688 0
anaesthesiainstitute@yahoo.com
Contact person for scientific queries
Name 3616 0
Dr Dr Michael Fredrickson
Address 3616 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3616 0
New Zealand
Phone 3616 0
+64 9 522 1117
Fax 3616 0
+64 9 522 1127
Email 3616 0
anaesthesiainstitute@yahoo.com

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.