|
ISRCTN
|
ISRCTN59113767
|
|
ClinicalTrials.gov identifier
|
|
|
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
|
|
Serial number at source
|
N0077183569
|
|
Study hypothesis
|
Does local anaesthetic (lignocaine) reduce pain associated with dressing removal of fingertip injuries when compared to normal saline?
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Signs and Symptoms: Pain
|
|
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
|
|
Anticipated start date
|
21/08/2006
|
|
Anticipated end date
|
31/01/2008
|
|
Status of trial
|
Stopped
|
|
Patient information material
|
|
|
Target number of participants
|
98
|
|
Interventions
|
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.
|
|
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)
|
No secondary outcome measures
|
|
Sources of funding
|
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
D N
Quinton
|
|
Address
|
Derby Hospitals NHS Foundation Trust
Derbyshire Royal Infirmary
London Road
|
|
City/town
|
Derby
|
|
Zip/Postcode
|
DE1 2QY
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01332 347141 ext: 2249
|
|
Fax
|
+44 01332 254638
|
|
Email
|
david.quinton@derbyhospitals.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
27/08/2008
|
|
Date ISRCTN assigned
|
28/09/2007
|
