Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000749000
Ethics application status
Approved
Date submitted
6/09/2010
Date registered
8/09/2010
Date last updated
14/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Injection Infraclavicular vs. Distal Peripheral Nerve Block for Wrist and Hand Surgery
Scientific title
Single Injection Infraclavicular vs. Distal Peripheral Nerve Block for Wrist and Hand Surgery to Compare Patient Satisfaction
Secondary ID [1] 252652 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia after wrist and hand surgery 258132 0
Condition category
Condition code
Anaesthesiology 258309 258309 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Distal Peripheral Nerve Block Group: A preoperative (30 mins prior to surgery) one-off ultrasound guided block of the radial (at distal humerus), median and ulnar nerves (at the forearm level) will be performed using 3x 6 ml of ropivacaine 0.5%.Patients will also receive an ultrasound-guided infraclavicular injection of lignocaine 1.5% 30 ml with adrenaline 1/200,000 40 mins prior to surgery to cover torniquet pain.
Intervention code [1] 257148 0
Treatment: Drugs
Intervention code [2] 257161 0
Treatment: Surgery
Comparator / control treatment
Infraclavicular Group:

A preoperative one-off ultrasound guided block of the infraclavicular brachial plexus will be performed: following standard intravascular injection precautions, 30 ml 20:10 ropivacaine 0.75%: lignocaine 2% with adrenaline 1/200,000 will be injected posterior to the axillary artery.
The duration/frequency of this treatment is the same as the intervention arm with the only difference being the site where the block is administered.
Control group
Active

Outcomes
Primary outcome [1] 259161 0
Patient satisfaction as assessed by patient questionnaire using a simple 11-point numerical rating satisfaction scale.
Timepoint [1] 259161 0
24 hours postoperatively.
Secondary outcome [1] 265493 0
Postoperative pain as assessed by patient questionnaire and 11-point numerical rating pain scale.
Timepoint [1] 265493 0
24-hrs post operatively
Secondary outcome [2] 265525 0
Arm numbness/weakness as assessed by questionnaire and 11-point numerical rating numbness/weakness scale.
Timepoint [2] 265525 0
24-hrs postoperatively
Secondary outcome [3] 265526 0
Surgical anaesthesia success as assessed by the primary surgeon (patient interrogation)
Timepoint [3] 265526 0
1-2 hrs after block placement
Secondary outcome [4] 265527 0
Procedural pain using simple 11-point numerical rating pain scale.
Timepoint [4] 265527 0
At the time of block placement (patient interrogation)

Eligibility
Key inclusion criteria
Patients requiring surgical anaesthesia for hand or wrist surgery under the care of the principal and co-investigators.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include patient refusal for brachial plexus block, known neuropathy involving the arm undergoing surgery and 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 one week prior to surgery, where patients will be contacted by a research assistant and invited to participate. Written informed consent will be obtained from all patients. Assignment of the patient to one of the 2 groups will be delivered in sealed opaque envelopes.
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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 2852 0
New Zealand
State/province [1] 2852 0
Auckland

Funding & Sponsors
Funding source category [1] 257601 0
Government body
Name [1] 257601 0
NZ Lottery Grants Board
Country [1] 257601 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] 256827 0
None
Name [1] 256827 0
Address [1] 256827 0
Country [1] 256827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259621 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 259621 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 259621 0
New Zealand
Date submitted for ethics approval [1] 259621 0
Approval date [1] 259621 0
08/07/2010
Ethics approval number [1] 259621 0
NTY/10/EXP/056

Summary
Brief summary
Brachial plexus block is a commonly performed anaesthetic/analgesic technique for elective wrist and hand surgery. Traditionally, long acting local anaesthetic is used which provides 12-15 hours potent postoperative analgesia; however, some patients experience dissatisfaction from the inevitable proximal limb paralysis. The recent availability in the operating room of portable ultrasound equipment has made it very feasible to block, at the level of the forearm, the individual nerves supplying the wrist and hand. This enables the provision of potent analgesia but without proximal extremity motor weakness. A potential disadvantage of this approach, however, is that the duration of blockade may be shorter.
The 2 approaches are to be compared in a prospective randomised manner with patient satisfaction as the primary outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31609 0
Address 31609 0
Country 31609 0
Phone 31609 0
Fax 31609 0
Email 31609 0
Contact person for public queries
Name 14856 0
Dr Michael Fredrickson
Address 14856 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 14856 0
New Zealand
Phone 14856 0
+64 9 522 1117
Fax 14856 0
+64 9 522 1127
Email 14856 0
[email protected]
Contact person for scientific queries
Name 5784 0
Dr Michael Fredrickson
Address 5784 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 5784 0
New Zealand
Phone 5784 0
+64 9 522 1117
Fax 5784 0
+64 9 522 1127
Email 5784 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.