Trial of Articaine for Peribulbar Anaesthesia

ISRCTN	ISRCTN24745856
DOI	https://doi.org/10.1186/ISRCTN24745856
Secondary identifying numbers	N0203052841

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 20/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Keith Allman
Scientific

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

Phone	+44 (0)1392 402474
Email	abc@123.com

Study information

Study design	Randomised double-blinded patient study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	-
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	articaine prilocaine
Primary outcome measure	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 study start date	01/01/2000
Completion date	31/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	200
Key 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.
Key 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.
Date of first enrolment	01/01/2000
Date of final enrolment	31/07/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Not defined

Royal Devon and Exeter NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/02/2020: No publications found, all search options exhausted, study status unverified.