Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
13/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Bruce Whiteley

ORCID ID

Contact details

Senior Podiatrist
Therapy Centre
'O' Block
West Middlesex University Hospital
Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0082164453

Study information

Scientific title

Acronym

Study hypothesis

Does the administration of local anaesthetic in two stages rather than one stage reduce the length of time the patient experience pain and/or the degree of pain?

Ethics approval

Ethics approval received from the Hounslow and Hillingdon Research Ethics Committee in May 2005 (ref: 05Q0407/32).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery: Nails

Intervention

Two different methods of local anaesthesia for nail surgery under local anaesthetic will be carried out on a population attending a therapy centre at a district hospital. Recruitment will be consecutive and patients will be randomly assigned a number which will indicate to the clinician which technique to administer to which side of the great toe. The decision to use method 1 or 2 will be random/alternated medially and laterally to eliminate any bias. The patient will not know which is the standard and which the variant technique. Therefore, the study is single blinded.

During the administration of local anaesthetic, patients will be given a stopwatch and asked to time the period they feel pain/discomfort. The watch is stopped when there is a cessation of pain. The watch will be stopped if running, when the needle is withdrawn from the toe at the end of delivery. In order to numb the patients toe, an injection must be given to either side of the toe. This is typically a very small amount of fluid per injection e.g. between 1 and 2 millilitres. We will inject one side of the toe using method 1 and the other side using method 2.
1. Method 1 involves giving the injection in one go
2. Method 2 involves giving the injection in two stages. A small amount is given initially and the needle is withdrawn. After waiting two minutes a further injection is given into the same site using the remainder of the cartridge.

During each injection, the patient will be given a stopwatch and asked to start it when they experience discomfort and stop the watch when this goes away. Some people may wish to start and stop the watch a number of times. After each injection the patient will be asked to indicate the level of pain on a 10 cm visual analogue scale and register their preferences for method 1, method 2, or neither.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

An assessment of which method of local anaesthesia is experienced as least painful by patients entered into the study: length of time pain is experienced and intensity of pain experienced for the two methods being compared.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/12/2004

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Fifty patients will be recruited into the study. Each patient will act as his or her own control. Inclusion criteria are:
1. Patient is suitable for digital local anaesthesia for nail surgery
2. Requires partial nail avulasion - medial, lateral or both.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients who have mental health problems/learning disabilities
2. Needle phobia
3. Known psychosomatic reaction to injections
4. Being under 16 years old
5. Inability to use a stopwatch (to stop and start when pain is felt/stops being felt)
6. Patients who have peripheral neuropathy

Recruitment start date

11/12/2004

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Podiatrist
Isleworth
TW7 6AF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

Hounslow Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20188280

Publication citations

  1. Results

    Whiteley B, Rees S, A randomized controlled trial to compare two techniques for partial digital local anesthetic blocks., J Foot Ankle Surg, 49, 2, 143-146, doi: 10.1053/j.jfas.2009.12.004.

Additional files

Editorial Notes