A comparative study of two digital anaesthetic techniques
| ISRCTN | ISRCTN17828634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17828634 |
| Secondary identifying numbers | N0082164453 |
- 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
Scientific
Senior Podiatrist
Therapy Centre
'O' Block, West Middlesex University Hospital
Twickenham Road
Isleworth
TW7 6AF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 The watch will be stopped if running, when the needle is withdrawn from the toe at the end of delivery.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 | 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 study start date | 11/12/2004 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Senior Podiatrist
Isleworth
TW7 6AF
United Kingdom
TW7 6AF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Hounslow Primary Care Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
