Contact information
Type
Scientific
Primary contact
Mr D N Quinton
ORCID ID
Contact details
Derby Hospitals NHS Foundation Trust
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 01332 347141 ext: 2249
david.quinton@derbyhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077183569
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
lignocaine versus normal saline
Primary outcome measures
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 trial start date
21/08/2006
Overall trial end date
31/01/2008
Reason abandoned
Too much bureaucracy
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
98
Participant 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
Recruitment start date
21/08/2006
Recruitment end date
31/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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
Results - basic reporting
Publication summary