Trial of Articaine for Peribulbar Anaesthesia
| ISRCTN | ISRCTN24745856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24745856 |
| Protocol serial number | N0203052841 |
| Sponsor | Department of Health |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- 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
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| Phone | +44 (0)1392 402474 |
|---|---|
| abc@123.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blinded patient study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | articaine prilocaine |
| Primary outcome measure(s) |
Study endpoints: comparison of the degree of anaesthesia and akinesia achieved with Articaine and prilocaine when using a single injection peribulbar technique. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/02/2020: No publications found, all search options exhausted, study status unverified.
