A prospective study to assess the effectiveness of lignocaine versus normal saline in the reduction of pain associated with dressing removal in fingertip injuries
| ISRCTN | ISRCTN59113767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59113767 |
| Secondary identifying numbers | N0077183569 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 27/08/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D N Quinton
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
| Phone | +44 01332 347141 ext: 2249 |
|---|---|
| david.quinton@derbyhospitals.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does local anaesthetic (lignocaine) reduce pain associated with dressing removal of fingertip injuries when compared to normal saline? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | 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. Added 27 August 2008: trial was stopped. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lignocaine versus normal saline |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 21/08/2006 |
| Completion date | 31/01/2008 |
| Reason abandoned (if study stopped) | Too much bureaucracy |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 98 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/08/2006 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 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
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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 |
