Comparison of 4% articaine and bupivacaine/lignocaine for sub-tenon anaesthesia in phacoemulsification cataract surgery
| ISRCTN | ISRCTN40732847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40732847 |
| Secondary identifying numbers | N0203132063 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 22/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Vasant Raman
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| Phone | +44 (0)1392 406033 |
|---|---|
| Vasant317@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To assess if articaine 4% is a suitable and SAFE agent for use in sub-tenon anaesthesia of the eye (for cataract surgery). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cataract surgery |
| Intervention | Patients will be randomly allocated to one of two groups using sealed, numbered envelopes and computer randomisation. Group A will receive sub-tenon's anaesthesia using 4% articaine and group B will receive a mixture of equal volume of 0.5% bupivicaine and 2% lignocaine. Ocular movements will be scored for each direction of gaze in the superior, inferior, medial and lateral directions with a maximum score for each direction of 3 points and a possible total maximum of 12 points. Patients will be considered to be ready for surgery when the ocular scores are 5 or less. Table showing scoring system for ocular movements. Full Movement 3/ Moderate Movement 2/ Flicker of movement 1/ No movement 0. In addition formal ocular motility testing will be undertaken at the orthoptics department immediately before and after surgery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Articaine, bupivacaine/lignocaine |
| Primary outcome measure | The aim of the trial is to examine the possibility that the success rate of sub-tenon anaesthesia can be improved by using 4% articaine rather than the presently used combination of lignocaine/bupivacaine. Sub-tenon's anaesthesia has distinct advantages over 'sharp needle' technique, chiefly being globe perforation but currently, acceptance of this technique is hampered by poor success rate. If the success rate of sub-tenons anaesthesia could be enhanced by 4% articaine then it would become a widely used technique. Study endpoints: Collating data and to see if 4% articaine is safe and effective compared to existing lignocaine/bupivacaine anaesthetic agent. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/09/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 65 |
| Key inclusion criteria | Patient will be selected at random from the waiting list. Letters will be sent out to the patient along with appointment letter. They will be contacted a day prior to surgery and their willingness to participate ascertained on the day of surgery. |
| Key exclusion criteria | 1. Aged less than 18 years 2. Previous intra-ocular surgery 3. Pupil diameter less than 5 mm when fully dilated 4. Pregnant females or of child bearing potential 5. Those known to have reduced plasma chlolinesterase levels 6. Patient unwilling to participate in the study 7. A history of allergy to amide-type anaesthetics 8. Subjects of non-therapeutic research |
| Date of first enrolment | 16/09/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/2008 | Yes | No |
