A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria

National Eye Centre, Kaduna

Status and phase: Completed; Phase 4

Conditions: Anaesthesia; Cataract

Treatments: Procedure: One-site peribulbar injection; Procedure: Two- site peribulbar injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02150460

NECKAD/TRIALS/001/2012

Details and patient eligibility

About

The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.

This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 50 years and above
• Diagnosed with uncomplicated senile cataract
• Visual acuity of <3/60

Exclusion criteria

• Impaired mental status
• Difficulty in speaking
• Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
• Previous surgery in the same eye
• Glaucoma
• Impaired ocular motility
• Eyelid abnormalities
• Patients with only one eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

One-site peribulbar injection

Experimental group

Description:

Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment

Treatment:

Procedure: One-site peribulbar injection

Two-site peribulbar injection

Active Comparator group

Description:

Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments

Treatment:

Procedure: Two- site peribulbar injection