| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN59113767 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0077183569 |
| Public title | A prospective study to assess the effectiveness of lignocaine versus normal saline in the reduction of pain associated with dressing removal in fingertip injuries |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Signs and Symptoms: Pain |
| Study hypothesis | Does local anaesthetic (lignocaine) reduce pain associated with dressing removal of fingertip injuries when compared to normal saline? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients sustaining a nail bed injury
2. Patients who are old enough to give consent (over 16 years old)
3. Patients willing to participate |
| Participants - exclusion criteria | 1. Patients who are unable to give consent
2. Previous injury or surgery to the presenting digit
3. Patients within any other concomitant trial involving analgesics, patient allergy to lignocaine |
| Patient information material |
|
| Anticipated start date | 21/08/2006 |
| Anticipated end date | 31/01/2008 |
| Status of trial | Completed |
| Target number of participants | 98 |
| Interventions | Randomized Controlled Trial
Patients will be recruited from the Pulvertaft Hand Center upon clinic appointment. This is a stop interview /evaluation that takes place in the Hand Clinic. Certain data will be collected - age, sex, nature of injury, etc. This will be kept confidential. Patients will be asked whether they would like to be involved in the study. Those patients who agree will be asked to sign a consent form. The patients who do not wish to participate in the study will receive the normal standard of care for such injuries, ie. normal saline.
The following protocol will be set up:
- Affected finger will be immersed in 10 milliliters of local anaesthetic (lignocaine) or normal saline.
- The dressing is then removed by the sister in the clinic and the patient asked to log their level of pain. This will be achieved by a simple (linear analogue) scoring system.
The whole process will be randomised and blind to those involved in the study to avoid or prevent bias. |
| Primary outcome measure(s) | The reduction in the level of pain on dressing removal of patients with fingertip wounds as shown on the linear visual analogue pain scale, 0-10, 0 being the lowest level of pain and 10 the highest level of pain. |
| Secondary outcome measure(s) | None |
| Sources of funding | Derby Hospitals NHS Foundation Trust
NHS R&D Support Funding
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr D N Quinton |
| Contact details | Derby Hospitals NHS Foundation Trust _ DRI
Derbyshire Royal Infirmary
London Road
Derby
United Kingdom
DE1 2QY |
| Contact telephone | +44 01332 347141 ext: 2249 |
| Contact fax | +44 01332 254638 |
| Contact email | david.quinton@derbyhospitals.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59113767 |
| Date last extracted from ISRCTN register | 17/04/2008 |
