Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
30/07/2012
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

Dr Keith Allman

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 402474

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203052841

Study information

Scientific title

Acronym

Study hypothesis

Would articaine be suitable, safe and reliable anaesthetic for peribulbar anaesthesia?

Peribulbar anaesthesia is the most commonly employed anaesthetic for cataract surgery. This involves normally two injections of local anaesthetic around the eye to achieve analgesia and akinesia. Each injection carries a risk globe perforation or haemorrhage which can in extreme cases cause blindness. Recently a single injection technique has been described, but failure to achieve akinesia can be as high as 40% due to inadequate diffusion of the local anaesthetic agent.
Articaine is a local anaesthetic used principally in dental practice because of its safety and good diffusion properties.
We propose to trial the use of Articaine for peribulbar anaesthesia to examine if these diffusion properties could be useful in reducing morbidity from peribulbar anaesthesia by reducing the number of injections needed.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blinded patient study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

We intend to compare the effectiveness of articaine against the current standard-agent (prilocaine) when used for peribulbar anaesthesia.
Patients attending for cataract surgery, and giving informed consent, will be randomly allocated to receive anaesthesia with one of the two agents. A standard single injection technique of peribulbar anaesthesia will be used. Akinesia will be assessed at one, five and ten minutes, and where necessary a second 'top-up' injection performed at five minutes.
The results will let us compare the effectiveness of Articaine when used for peribulbar anaesthesia and also demonstrate if the diffusion of Articaine is sufficient to enable reliable anaesthesia when using only a single peribulbar injection.

Intervention type

Drug

Phase

Not Specified

Drug names

articaine prilocaine

Primary outcome measures

Study endpoints: comparison of the degree of anaesthesia and akinesia achieved with Articaine and prilocaine when using a single injection peribulbar technique.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients age 16 - 100 years (patient population attending for eye surgery tends in practice to be elderly with an expected average age of around 70 years). Patients attending for cataract surgery under local anaesthesia will be invited to join the study. Patients will be sent an information sheet explaining the purpose of the trial with their booking letter. Consent to take part in the trial will then be obtained after discussion with one of the investigators on the day of admission.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Patients will be excluded if less than 16 years of age, female (if pregnant or of child bearing potential) or known to have reduced plasma cholinesterase levels.

Recruitment start date

01/01/2000

Recruitment end date

31/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Not defined

Funder name

Royal Devon and Exeter NHS Trust (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

Publication citations

Additional files

Editorial Notes