Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000155099
Ethics application status
Approved
Date submitted
15/02/2010
Date registered
16/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of routine administration of distal peripheral nerve blockade for wrist and hand surgery
Scientific title
The effectiveness of routine administration of distal peripheral nerve blockade for wrist and hand surgery
Secondary ID [1] 1406 0
Nil
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 256810 0
Condition category
Condition code
Anaesthesiology 256960 256960 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided combined peripheral/infraclavicular (perineural) block with 30mL lignocaine 1.5%, followed immediately by an additional ultrasound guided block of median, radial and ulnar nerves at the level of the forearm using 12mL of a mixture of lignocaine 1.5%/ropivacaine 0.75%.
Block duration approx 5 min.
Intervention code [1] 256019 0
Treatment: Drugs
Comparator / control treatment
Ultrasound guided infraclavicular (perineural) block with 42ml of 1.5% lignocaine followed immediately after the 15 min block assessment by an additional ultrasound guided block of the median, radial and ulnar nerves at the level of the forearm using a total of 12mL of ropivacaine 0.375%. Block duration approx 5 min.
Control group
Active

Outcomes
Primary outcome [1] 257845 0
Block effectiveness as assessed by sensory (pin prick) and motor block (simple 4 point motor block scale) in the 4 distal nerve territories.
Timepoint [1] 257845 0
15 min after block placement
Secondary outcome [1] 263273 0
Block placement time
Timepoint [1] 263273 0
During block placement
Secondary outcome [2] 263274 0
Surgical Anaesthesia success: adequacy of anaesthesia to conduct the surgical procedure. It will be assessed by the surgeon based on whether the anaesthesia is satisfactory or not.
Timepoint [2] 263274 0
1-2 hours post procedure

Eligibility
Key inclusion criteria
Patients requiring surgical anaesthesia for minor hand or wrist surgery under the care of the principal investigator.
Minimum age
16 Years
Maximum age
80 Years
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 or combined block 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
10/02/2010
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] 2495 0
New Zealand
State/province [1] 2495 0

Funding & Sponsors
Funding source category [1] 256516 0
Self funded/Unfunded
Name [1] 256516 0
Dr Michael Fredrickson
Country [1] 256516 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] 255825 0
None
Name [1] 255825 0
Address [1] 255825 0
Country [1] 255825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258562 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 258562 0
P O Box 1031,
Hamilton,
Waikato Mail Centre 3240.
Ethics committee country [1] 258562 0
New Zealand
Date submitted for ethics approval [1] 258562 0
Approval date [1] 258562 0
10/02/2010
Ethics approval number [1] 258562 0
NTY/10/EXP/008

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of a combined peripheral/infraclavicular block for minor hand or wrist surgery. Increased exposure of this technique may promote uptake in this setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30841 0
Address 30841 0
Country 30841 0
Phone 30841 0
Fax 30841 0
Email 30841 0
Contact person for public queries
Name 14088 0
Dr Michael Fredrickson
Address 14088 0
Anaesthesia Institute,
P O Box 109 199,
Newmarket,
Auckland 1149.
Country 14088 0
New Zealand
Phone 14088 0
+64 9 522 1117
Fax 14088 0
+64 9 522 1127
Email 14088 0
[email protected]
Contact person for scientific queries
Name 5016 0
Dr Michael Fredrickson
Address 5016 0
Anaesthesia Institute,
P O Box 109 199,
Newmarket,
Auckland 1149.
Country 5016 0
New Zealand
Phone 5016 0
+64 9 522 1117
Fax 5016 0
+64 9 522 1127
Email 5016 0
[email protected]

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.