Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
27/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes