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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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