Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0082164453
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Hounslow and Hillingdon Research Ethics Committee in May 2005 (ref: 05Q0407/32).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 The watch will be stopped if running, when the needle is withdrawn from the toe at the end of delivery.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 A small amount is given initially and the needle is withdrawn.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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/12/2004
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
11/12/2004
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Senior Podiatrist
Isleworth
TW7 6AF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hounslow Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20188280
Publication citations
-
Results
Whiteley B, Rees S, A randomized controlled trial to compare two techniques for partial digital local anesthetic blocks., J Foot Ankle Surg, 49, 2, 143-146, doi: 10.1053/j.jfas.2009.12.004.