Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001073998p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2020
Date registered
19/10/2020
Date last updated
19/10/2020
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sensory innervation of the forearm detected by ultrasound-guided local anaesthetic block
Scientific title
Distribution pattern and area of sensory overlap of the posterior antebrachial, medial antebrachial and lateral antebrachial cutaneous nerves of the forearm detected by ultrasound guided local anaesthetic nerve block in healthy volunteers.
Secondary ID [1] 301750 0
Nil
Universal Trial Number (UTN)
U1111-1255-1752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensory innervation of skin of forearm and hand 318209 0
Condition category
Condition code
Neurological 316216 316216 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to precisely map the distribution pattern, area of sensory overlap and any proximal extension into the hand of the three antebrachial cutaneous nerves of the forearm. This has not been previously reported. The posterior ante-brachial cutaneous nerve (PABCN) medial ante-brachial cutaneous nerve (MABCN) and lateral ante-brachial cutaneous nerve (LABCN) will be located with ultrasound and separately blocked with local anaesthetic (lidocaine). The total cutaneous sensory block area (CSBA) for each individual nerve will be mapped.
Sensation will be tested using a Neuropen. This device is used in the screening of peripheral neuropathy.
Overlapping areas of innervation in the forearm and hand will be reported as a percentage of the total CSBA. Areas of the forearm that remain unblocked will be reported as a percentage of the total CSBA.
Sensory mapping will be done for all three nerves on separate occasions. The time to complete mapping will be less than 15 minutes.
The total duration of the study will be approximately one hour on 3 separate days. On the fourth day the study time will be less than 5 minutes. Mapping will be done by the PI.
The PI is a senior anaesthetist with 20 years experience in regional anaesthesia.
There will be no movement required of the participants for mapping.
The local anaesthetic drug lidocaine will be used to anaesthetise the nerves using a small needle introduced through the skin.
The purpose of the study is to mapping the sensory distribution of the cutaneous nerves of the forearm.
Intervention code [1] 318047 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324402 0
The CSBA for each individual nerve will be mapped by testing for loss of sharp touch sensation with a peripheral neuropathy screening device (Neuropen)
The total CSBA (cm2) for each individual nerve will then be calculated from photographs of a paper transparency using the software SketchAndCalc. This software can be used to draw a perimeter around a shape to calculate an area.
Timepoint [1] 324402 0
Individual nerves will be assessed on days 1, 2 and 3 post-enrolment.
Primary outcome [2] 324403 0
Areas of sensory overlap will be determined by examining the tracings of the CSBA of individual nerves. Areas that overlap will be marked on the transparency and the software SketchAndCalc used to determine this area.
The SketchAndCalc software can be used to draw a perimeter around a shape to calculate an area.
Timepoint [2] 324403 0
Individual nerves will be assessed on days 1,2 and 3 post-enrolment.
Secondary outcome [1] 384563 0
If sensory block in the hand occurs the area will be mapped and reported according to which nerve was mapped i.e the PABCN, LABCN or MABCN
The area of sensory block in the hand will be reported as a percentage for each nerve using the software SketchAndCalc. This software can be used to draw a perimeter around a shape to calculate an area.
Timepoint [1] 384563 0
Individual nerves will be assessed on Days 1, 2 and 3 post-enrolment,
Secondary outcome [2] 384564 0
Areas that remain unblocked will be outlined on the transparency and reported as a percentage of the total CSBA for all nerves. The application SketchAndCalc will be used. This software can be used to draw a perimeter around a shape to calculate an area.
Timepoint [2] 384564 0
Days 1, 2 and 3 post-enrolment,

Eligibility
Key inclusion criteria
Healthy volunteers, male and female aged 18-65, BMI 18-35 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known allergy to local anaesthetic drugs; injury, deformity or previous surgery to the right arm or cutaneous nerves of the forearm; pain or pre-exiting neurological deficit of the right arm; identifying features on the arm such as tattoos, moles, scars or birthmarks.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be using a sample size of 12. This is consistent with prior studies which have explored cutaneous innervation and sensation in the hand and forearm. Gender, age and body mass index (BMI) of volunteers will be reported. These variables ensure that the volunteers are representative of the study population. The total cutaneous sensory block area (CSBA) for each individual nerve will be mapped.
Overlapping areas of innervation in the forearm and hand will be reported as a percentage of the total CSBA. Areas of the forearm that remain unblocked will be reported as a percentage of the total CSBA. Any failed block will be reported. The area of sensory cutaneous loss and overlap will be depicted in diagrams and photographs. Any adverse events will be documented and reported. Statistical data will be reported as median and range

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
21/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30725 0
2137 - Concord

Funding & Sponsors
Funding source category [1] 306183 0
Hospital
Name [1] 306183 0
Concord Repatriation General Hospital
Country [1] 306183 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Road
Concord
NSW 2137
Country
Australia
Secondary sponsor category [1] 306656 0
None
Name [1] 306656 0
Address [1] 306656 0
Country [1] 306656 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306395 0
Sydney Local Area Human Research Ethics Committee-Concord Repatriation General Hospital
Ethics committee address [1] 306395 0
Ethics committee country [1] 306395 0
Australia
Date submitted for ethics approval [1] 306395 0
01/08/2020
Approval date [1] 306395 0
Ethics approval number [1] 306395 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103734 0
Dr Philip John Corke
Address 103734 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Hospital Road
Concord
NSW 2137
Country 103734 0
Australia
Phone 103734 0
+61 297676450
Fax 103734 0
Email 103734 0
[email protected]
Contact person for public queries
Name 103735 0
Philip John Corke
Address 103735 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Hospital Road
Concord
NSW 2137
Country 103735 0
Australia
Phone 103735 0
+61 297676450
Fax 103735 0
Email 103735 0
[email protected]
Contact person for scientific queries
Name 103736 0
Philip John Corke
Address 103736 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Hospital Road
Concord
NSW 2137
Country 103736 0
Australia
Phone 103736 0
+61 297676450
Fax 103736 0
Email 103736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8472Study protocol  [email protected] 380169-(Uploaded-07-08-2020-15-11-12)-Study-related document.docx



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.