A comparative study of two digital anaesthetic techniques

ISRCTN	ISRCTN17828634
DOI	https://doi.org/10.1186/ISRCTN17828634
Protocol serial number	N0082164453
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Hounslow Primary Care Trust (UK), NHS R&D Support Funding (UK)

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 13/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Bruce Whiteley
Scientific

Senior Podiatrist
Therapy Centre
'O' Block, West Middlesex University Hospital
Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does the administration of local anaesthetic in two stages rather than one stage reduce the length of time the patient experience pain and/or the degree of pain?
Ethics approval(s)	Ethics approval received from the Hounslow and Hillingdon Research Ethics Committee in May 2005 (ref: 05Q0407/32).
Health condition(s) or problem(s) studied	Surgery: Nails
Intervention	Two different methods of local anaesthesia for nail surgery under local anaesthetic will be carried out on a population attending a therapy centre at a district hospital. Recruitment will be consecutive and patients will be randomly assigned a number which will indicate to the clinician which technique to administer to which side of the great toe. The decision to use method 1 or 2 will be random/alternated medially and laterally to eliminate any bias. The patient will not know which is the standard and which the variant technique. Therefore, the study is single blinded. During the administration of local anaesthetic, patients will be given a stopwatch and asked to time the period they feel pain/discomfort. The watch is stopped when there is a cessation of pain. The watch will be stopped if running, when the needle is withdrawn from the toe at the end of delivery. In order to numb the patients toe, an injection must be given to either side of the toe. This is typically a very small amount of fluid per injection e.g. between 1 and 2 millilitres. We will inject one side of the toe using method 1 and the other side using method 2. 1. Method 1 involves giving the injection in one go 2. Method 2 involves giving the injection in two stages. A small amount is given initially and the needle is withdrawn. After waiting two minutes a further injection is given into the same site using the remainder of the cartridge. During each injection, the patient will be given a stopwatch and asked to start it when they experience discomfort and stop the watch when this goes away. Some people may wish to start and stop the watch a number of times. After each injection the patient will be asked to indicate the level of pain on a 10 cm visual analogue scale and register their preferences for method 1, method 2, or neither.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	An assessment of which method of local anaesthesia is experienced as least painful by patients entered into the study: length of time pain is experienced and intensity of pain experienced for the two methods being compared.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	Fifty patients will be recruited into the study. Each patient will act as his or her own control. Inclusion criteria are: 1. Patient is suitable for digital local anaesthesia for nail surgery 2. Requires partial nail avulasion - medial, lateral or both.
Key exclusion criteria	1. Patients who have mental health problems/learning disabilities 2. Needle phobia 3. Known psychosomatic reaction to injections 4. Being under 16 years old 5. Inability to use a stopwatch (to stop and start when pain is felt/stops being felt) 6. Patients who have peripheral neuropathy
Date of first enrolment	11/12/2004
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Senior Podiatrist

Isleworth
TW7 6AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010		Yes	No