Comparison of 4% articaine and bupivacaine/lignocaine for sub-tenon anaesthesia in phacoemulsification cataract surgery
| ISRCTN | ISRCTN40732847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40732847 |
| Protocol serial number | N0203132063 |
| Sponsor | Department of Health |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| Phone | +44 (0)1392 406033 |
|---|---|
| Vasant317@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Articaine, bupivacaine/lignocaine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/2008 | Yes | No |
