Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001274965
Ethics application status
Not yet submitted
Date submitted
5/12/2011
Date registered
12/12/2011
Date last updated
12/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Pattern of skin anaesthesia with ultrasound-guided lateral femoral cutaneous nerve of thigh blockade linked to the usual location of surgical incision for hip surgery.
Scientific title
Pattern of skin anaesthesia in healthy volunteers with ultrasound-guided lateral femoral cutaneous nerve of thigh blockade linked to the usual location of surgical incision for hip surgery.
Secondary ID [1] 273539 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative analgesia for hip surgery 279341 0
Condition category
Condition code
Anaesthesiology 279525 279525 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided lateral femoral cutaneous nerve block using 1-5ml of 1% lignocaine. 5ml will be the maximum used. More commonly 1-2ml will be required.

The exact amount will be determined by the operator performing the block who can visualise when the nerve is surrounded by local anaesthetic solution.

The entire process (from start to adequate nerve block with area of numbness mapped out and incision sites drawn on) will take between 10 minutes and 30 minutes. This will depend upon the technical difficulty of the nerve blockade itself and how long it takes for the nerve block to work.
Intervention code [1] 283850 0
Treatment: Other
Intervention code [2] 283869 0
Treatment: Drugs
Comparator / control treatment
No control. All participants will have a nerve block performed, the anaesthesia of the skin will be mapped out and the usual site of skin incision will be marked out. The distribution of the numbness will be compared with the usual site of incision (in all volulnteers).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286092 0
Distribution of skin anaesthesia after nerve blockade assessed using ice to check sensation and marked with non-permanent marker pen.
Timepoint [1] 286092 0
15 minutes after intervention.
Secondary outcome [1] 295116 0
Nil.
Timepoint [1] 295116 0
Not applicable.

Eligibility
Key inclusion criteria
Healthy volunteers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known lateral femoral cutaneous nerve palsy.
Previous reaction to local anaesthetic drugs.
Previous surgery to the hip joint.
Pregnancy.

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)
Healthy volunteer anaesthetists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
5/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284326 0
Hospital
Name [1] 284326 0
Department of Anaesthesia, Fremantle Hospital
Country [1] 284326 0
Australia
Primary sponsor type
Individual
Name
Adam Crossley
Address
Department of Anaesthesia
Fremantle Hospital
PO Box 80
Fremantle
WA. 6959.
Country
Australia
Secondary sponsor category [1] 283272 0
Individual
Name [1] 283272 0
Edmond O'Loughlin
Address [1] 283272 0
Department of Anaesthesia
Fremantle Hospital
PO Box 80
Fremantle
WA. 6959.
Country [1] 283272 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286290 0
Ethics committee address [1] 286290 0
Ethics committee country [1] 286290 0
Date submitted for ethics approval [1] 286290 0
27/11/2011
Approval date [1] 286290 0
Ethics approval number [1] 286290 0

Summary
Brief summary
Surgery on the hip joint is common but the provision of pain relief during and after the operation is challenging, especially since the patients are often frail and elderly.

Injection of a local anaesthetic drug near to the nerves that supply the hip (a ‘nerve block’) can be very effective but a number of different nerves supply the skin over the hip joint and blocking the whole of the surgical wound is difficult.

We plan a pilot study to map out the distribution of achievable pain relief when the lateral femoral cutaneous nerve (LFCN) is blocked under ultrasound guidance and relate this to the usual site of surgical incision for a variety of hip operations. This will indicate whether the block could provide reliable and effective pain relief to a predictable area of the hip.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33500 0
Address 33500 0
Country 33500 0
Phone 33500 0
Fax 33500 0
Email 33500 0
Contact person for public queries
Name 16747 0
Edmond O'Loughlin
Address 16747 0
Department of Anaesthesia
Fremantle Hospital
PO Box 480
Fremantle
WA. 6959.
Country 16747 0
Australia
Phone 16747 0
+61 8 9431 2551
Fax 16747 0
Email 16747 0
edmond.o'[email protected]
Contact person for scientific queries
Name 7675 0
Edmond O'Loughlin
Address 7675 0
Department of Anaesthesia
Fremantle Hospital
PO Box 480
Fremantle
WA. 6959
Country 7675 0
Australia
Phone 7675 0
+61 8 9431 2551
Fax 7675 0
Email 7675 0
edmond.o'[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.