Condition category
Eye Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Vasant Raman

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 406033
Vasant317@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203132063

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Articaine, bupivacaine/lignocaine

Primary outcome measures

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 trial start date

16/09/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant 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

Recruitment start date

16/09/2003

Recruitment end date

31/12/2005

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

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18211939

Publication citations

  1. Results

    Raman SV, Barry JS, Murjaneh S, Jacob J, Quinn A, Sturrock G, Shaw S, Allman K, Comparison of 4% articaine and 0.5% levobupivacaine/2% lidocaine mixture for sub-Tenon's anaesthesia in phacoemulsification cataract surgery: a randomised controlled trial., Br J Ophthalmol, 2008, 92, 4, 496-499, doi: 10.1136/bjo.2007.115576.

Additional files

Editorial Notes