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Comparison of 4% articaine and bupivacaine/lignocaine for sub-tenon anaesthesia in phacoemulsification cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40732847
Enrollment
65
Registered
2004-09-30
Start date
2003-09-16
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract surgery Eye Diseases Cataract surgery

Interventions

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 r

Sponsors

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026