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Trial registered on ANZCTR


Registration number
ACTRN12610000153011
Ethics application status
Not yet submitted
Date submitted
14/02/2010
Date registered
16/02/2010
Date last updated
16/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sonoplex needle: is it easier to see than our standard needle when performing ultrasound-guided local anaesthetic nerve blocks?
Scientific title
Ultrasound visibility of the Sonoplex needle: a randomised control trial in patients undergoing femoral and/or sciatic nerve block.
Secondary ID [1] 1407 0
Nil
Universal Trial Number (UTN)
U1111-1113-6023
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Needle visibility during ultrasound-guided local anaesthetic nerve block. 256814 0
Condition category
Condition code
Anaesthesiology 256966 256966 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Sonoplex' nerve block needle. This is a modification of the 'Nanoline' needle, with indentations in the shaft aimed at making it more visible under ultrasound. It has already proven effective in laboratory studies. The nerve block procedures themselves will be performed in accordance with our standard practice. This involves siting an intravenous drip, giving sedation/pain relief, sterile skin preparation and drapes and local anaesthetic injection into the skin. The nerve block needle is then passed through this anaesthetised skin to reach the desired nerve and local anaesthetic is injected around the nerve. The whole procedure is visualised using an ultrasound scanner and lasts less than 5 minutes.
Intervention code [1] 256022 0
Treatment: Devices
Comparator / control treatment
As above but using our standard 'Nanoline' nerve block needle
Control group
Active

Outcomes
Primary outcome [1] 257849 0
Anaesthetists estimate (verbal rating scale 1-4) of the time that the needle tip was visible on the ultrasound image as a proportion of the procedure time as a whole.
Timepoint [1] 257849 0
At the end of the nerve block procedure
Primary outcome [2] 257850 0
Objective measurement of the time that the needle tip is visible on the ultrasound image as a proportion of the procedure time as a whole.
Timepoint [2] 257850 0
Objective time measurements from the DVD recordings of each block.
Secondary outcome [1] 263294 0
Angle of needle insertion immediately prior to local anaesthetic injection
Timepoint [1] 263294 0
Taken from a still image on the DVD recording.
Secondary outcome [2] 263295 0
Time to perform nerve block
Timepoint [2] 263295 0
From DVD recording of block.

Eligibility
Key inclusion criteria
Patients due to have a femoral and/or a sciatic nerve block as part of their routine anaesthetic management
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent.
Ultrasound imaging not being used to guide nerve block procedure.

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)
Patient identified by anaesthetist during pre-op assessment as needing femoral and/or sciatic nerve blockade as part of their routine management.

Patient given written and verbal information regarding trial. All questions answered by study team or anaesthetist involved in care.

Informed consent obtained.

Study team randomise individual block procedures to either Nanoline or Sonoplex needles by computer-generated block randomisation using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation in blocks.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256520 0
Hospital
Name [1] 256520 0
Sir Charles Gairdner Hospital
Country [1] 256520 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 255831 0
None
Name [1] 255831 0
Address [1] 255831 0
Country [1] 255831 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258568 0
Human Research Ethics Committee
Ethics committee address [1] 258568 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6001
Ethics committee country [1] 258568 0
Australia
Date submitted for ethics approval [1] 258568 0
23/02/2010
Approval date [1] 258568 0
Ethics approval number [1] 258568 0

Summary
Brief summary
We intend to demonstrate whether the new Sonoplex needle is easier to see under ultrasound scanning than our standard Nanopline needle during routine anaesthetic nerve block procedures. This has already been shown in laboratory studies but not in live patients. We routimely use ultrasound to guide the passage of the nerve block needle and observe the spread of local anaesthetic around the nerve when performing nerve blocks for pain relief. We intend to recruit patients who are having nerve blocks as part of their routine anaesthetic and to randomise them (like flipping a coin) to having each block performed with either the Sonoplex or the Nanoline needle. We will record the ultrasound pictures anonomously for analysis. We will ask the anaesthetist performing the block to score how well they could see the needle tip and we will also assess this on the video data.
Trial website
None. May present ultrasound images (anonomised) on academic website in due course.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30836 0
Address 30836 0
Country 30836 0
Phone 30836 0
Fax 30836 0
Email 30836 0
Contact person for public queries
Name 14083 0
Dr Simon Hebard
Address 14083 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 14083 0
Australia
Phone 14083 0
+61 8 93463011
Fax 14083 0
Email 14083 0
[email protected]
Contact person for scientific queries
Name 5011 0
Dr Simon Hebard
Address 5011 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 5011 0
Australia
Phone 5011 0
+61 8 93463011
Fax 5011 0
Email 5011 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.