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Trial registered on ANZCTR


Registration number
ACTRN12610000531011
Ethics application status
Not yet submitted
Date submitted
25/06/2010
Date registered
30/06/2010
Date last updated
30/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of local anaesthetic type on injection-related pain levels intra and post operatively
Scientific title
In patients undergoing bilateral hallux blocks for partial nail avulsion, is mepivacaine a more effective local anaesthetic than lignocaine for reducing injection-related pain levels.
Secondary ID [1] 252104 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial Nail Avulsion 257657 0
Condition category
Condition code
Anaesthesiology 257835 257835 0 0
Anaesthetics
Neurological 257836 257836 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 2ml of 3% mepivacaine plain will be injected in the hallux (with 5ml syringe and a .25 gauge, 25mm in length) prior to the partial nail avulsion procedure. The subject will receive 1ml of mepivacaine into the soft tissue on the lateral (1st injection) and medial (2nd injection) aspects of the proximal phalanx. The partial nail avulsion will only be performed once the anaesthetic has taken effect. If anaesthesia has not been achieved then a top up injection will be performed.

The allocation of which hallux, right or left that receives lignocaine or mepivacaine will be randomised.

Immediately after the injections into the medal and lateral aspects of the toe the subject will complete a visual analogue pain scale, if further injections are required then the visual analogue scale will be completed after the first (lateral aspect) and second injection (medial aspect). Crossover will be achieved by the randomly selected hallux will receive lignocaine or mepivacaine and the opposite hallux will be injected immediately after the subject has completed the visual analogue scale.
Intervention code [1] 256728 0
Treatment: Drugs
Comparator / control treatment
A total of 2ml of 2% lignocaine plain will be injected in the hallux (with 5ml syringe and a .25 gauge, 25mm in length) prior to the partial nail avulsion procedure. The subject will receive 1ml of lignocaine into the soft tissue on the lateral (1st injection) and medial (2nd injection) aspects of the proximal phalanx. The partial nail avulsion will only be performed once the anaesthetic has taken effect. If anaesthesia has not been achieved then a top up injection will be performed.

The allocation of which hallux, right or left that receives lignocaine or mepivacaine will be randomised.

Immediately after the injections the subject will complete a visual analogue pain scale.
Control group
Active

Outcomes
Primary outcome [1] 258695 0
Pain measured by Visual Analogue Scale
Timepoint [1] 258695 0
Immediately after each toe has been injected
Secondary outcome [1] 264722 0
Pain measured by Visual Analogue Scale
Timepoint [1] 264722 0
24 hours after the time of the injections

Eligibility
Key inclusion criteria
Patients eligible for and undergoing bilateral hallux partial nail avultion surgery (in accordance with the University of Newcastle Podiatry criteria)

Minimum weight of 70kg

Able to safely receive the local anaesthetic agents used (in accordance with the University of Newcastle Podiatry criteria)

Over 18 yrs of age

Proficient in English to give Informed Consent and follow post-operative care instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Proficient in English to give Informed Consent and follow post-operative care instructions

Patients not meeting the inclusion criteria

Patients with medical conditions which contraindicate local anaesthetic use

Patients on medications which contraindicate local anaesthetic use

Patients with a known allergy to amide-type local anaesthetics

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)
A convenience sample will be identified by student practitioners and supervisors working at the podiaty clinic, suitably identified participants will then be assessed by Ms Eleanor Turvey for their inclusion in the study.

This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. The blinding will occur through use of equal amounts of both anaesthetics (2ml’s) and the administration of the local anaesthetic in needles and syringes of the same size (.25 gauge and 5ml respectively). Each syringe will be labeled A or B, according to its contents, by the data collector who will be independent of the practitioner to track which anaesthetic is used for each toe and which VAS refers to which anaesthetic type.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of which toe left or right will recieve lignocaine or mepivacaine.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2010
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] 257206 0
University
Name [1] 257206 0
University of Newcastle
Country [1] 257206 0
Australia
Primary sponsor type
Individual
Name
Mr Priten Solanki
Address
Podiatry
Faculty of Health
School of Health Sciences
PO Box 127
Ourimbah
New South Wales 2258
Country
Australia
Secondary sponsor category [1] 256460 0
Individual
Name [1] 256460 0
Dr Vivienne Chuter
Address [1] 256460 0
Podiatry
Faculty of Health
School of Health Sciences
PO Box 127
Ourimbah
New South Wales 2258
Country [1] 256460 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259235 0
Ethics committee address [1] 259235 0
Ethics committee country [1] 259235 0
Date submitted for ethics approval [1] 259235 0
12/07/2010
Approval date [1] 259235 0
Ethics approval number [1] 259235 0

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

Contacts
Principal investigator
Name 31341 0
Address 31341 0
Country 31341 0
Phone 31341 0
Fax 31341 0
Email 31341 0
Contact person for public queries
Name 14588 0
Mr Priten Solanki
Address 14588 0
University of Newcastle
Faculty of Health
School of Health Sciences
PO Box 127
Ourimbah
New South Wales 2258
Country 14588 0
Australia
Phone 14588 0
+61 2 4349 4655
Fax 14588 0
+61 2 4349 4538
Email 14588 0
priten.solanki@newcastle.edu.au
Contact person for scientific queries
Name 5516 0
Mr Priten Solanki
Address 5516 0
University of Newcastle
Faculty of Health
School of Health Sciences
PO Box 127
Ourimbah
New South Wales 2258
Country 5516 0
Australia
Phone 5516 0
+61 2 4349 4655
Fax 5516 0
+61 2 4349 4538
Email 5516 0
priten.solanki@newcastle.edu.au

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.