Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000646448
Ethics application status
Not yet submitted
Date submitted
29/11/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of a new needle used to deliver local anaesthetic solution onto peripheral nerves, thus enabling painless surgery to be performed. The visibility of these new needles under guided ultrasound will be assessed.
Scientific title
Examination of a newly developed needle which is more echo-genic than standard needles for use in peripheral nerve blockade. The outcome of this trial will be an assessment of the performance of these new needles when being used for a sciatic nerve block.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visibility of needles use in ultrsound 2596 0
Condition category
Condition code
Anaesthesiology 2708 2708 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compare two needles in sciatic nerve blockade. A standard 22g stimuplex needle (Standard needle for control) and a new modified 22g needle which has a textured tip (the new intervention being assessed). The needle will be inserted prior to surgery in the conscious patient. The trial is six months and the period of observation will be throughout the duration of surgery and at a 24 hour and 6 week follow up.
Intervention code [1] 2329 0
Treatment: Devices
Comparator / control treatment
The control needles are Stimulpex 22g needles. The new needles are modified 22g St Vincent Needle. Both needles will be inserted into the patient, one after the other, in a random order and their ultrasound visibility will be assessed. The local anaesthetic solution will be injected though the second needle onto the peripheral nerve. Nothing will be injected down the first needle.
Control group
Active

Outcomes
Primary outcome [1] 3632 0
Comparitive ultra-sonic vibibility of both needles.
Timepoint [1] 3632 0
During local nerve block procedure
Secondary outcome [1] 6043 0
Success of peripheral nerve block
Timepoint [1] 6043 0
30 minutes
Secondary outcome [2] 6084 0
Pain and discomfort on needle insertion
Timepoint [2] 6084 0
During local nerve block procedure

Eligibility
Key inclusion criteria
Patients having sciatic nerve blockade for lower limb surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient not giving concent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable patients will be asked to participate from a normal operating list, if they fulfill the inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a one to one comparison. The comparative assessment of the echo-genicity will be made off line using recorded images. The image assessor will not know which of the needles each image comes from. The comparative needles’ performance will then be assessed by the clinical trial’s co-ordinator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2886 0
Hospital
Name [1] 2886 0
St Vincent's Hospital
Country [1] 2886 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
1 Princess Street
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 2605 0
University
Name [1] 2605 0
Swinburne University of Technology
Address [1] 2605 0
1 John Street
Hawthorn VIC 3122
Country [1] 2605 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4802 0
St Vincent's Hospital
Ethics committee address [1] 4802 0
1 Princess Street
Fitzroy VIC 3065
Ethics committee country [1] 4802 0
Australia
Date submitted for ethics approval [1] 4802 0
27/11/2006
Approval date [1] 4802 0
Ethics approval number [1] 4802 0
Ethics committee name [2] 4824 0
St. Vincent's Hospital
Ethics committee address [2] 4824 0
1 Princess Street
Fitzroy VIC 3065
Ethics committee country [2] 4824 0
Australia
Date submitted for ethics approval [2] 4824 0
12/12/2007
Approval date [2] 4824 0
Ethics approval number [2] 4824 0
HREC-D #151/07

Summary
Brief summary
In order to perform peripheral nerve blockage a local anaesthetic has to be injected though a needle onto the selected nerve. Ultrasound guidance will help to accurately guide the needle to the selected site of the nerve. Unfortunately the needle is difficult to see especially when it is introduced at acute angles to the ultrasound beam. Our new needle is hoped to be more echogenic, thus improving the efficacy and safety of peripheral nerve blockade.
Trial website
Trial related presentations / publications
R K Deam, R Kluger, M J Barrington & C A McCutcheon, Anaesthesia & Intensive Care, 2007, Vol 35, PP 582-586
Public notes

Contacts
Principal investigator
Name 28220 0
Address 28220 0
Country 28220 0
Phone 28220 0
Fax 28220 0
Email 28220 0
Contact person for public queries
Name 11377 0
Roberta Deam
Address 11377 0
St Vincent's Hospital
1 Princess Street
Fitzroy VIC 3065
Country 11377 0
Australia
Phone 11377 0
+61 3 92882211
Fax 11377 0
Email 11377 0
[email protected]
Contact person for scientific queries
Name 2305 0
Roberta Deam
Address 2305 0
St Vincent's Hospital
1 Princess Street
Fitzroy VIC 3065
Country 2305 0
Australia
Phone 2305 0
+61 3 9288 2211
Fax 2305 0
Email 2305 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.