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

NCT ID: NCT02150460

Last Updated: 2015-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anaesthesia Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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One-site peribulbar injection

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

Group Type EXPERIMENTAL

One-site peribulbar injection

Intervention Type PROCEDURE

injection into the inferior medial orbital compartment

Two-site peribulbar injection

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

Group Type ACTIVE_COMPARATOR

Two- site peribulbar injection

Intervention Type PROCEDURE

Two injections into the infero-temporal and supero-nasal orbital compartments

Interventions

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One-site peribulbar injection

injection into the inferior medial orbital compartment

Intervention Type PROCEDURE

Two- site peribulbar injection

Two injections into the infero-temporal and supero-nasal orbital compartments

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Centre, Kaduna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminatu A AbdulRahman, MBBS, FWACS

Role: PRINCIPAL_INVESTIGATOR

National Eye Centre, Kaduna

Mahmoud B Alhassan, MBBS, FWACS

Role: STUDY_CHAIR

National Eye Centre, Kaduna

Locations

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National Eye Centre

Kaduna, Kaduna State, Nigeria

Site Status

Countries

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Nigeria

Other Identifiers

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NECKAD/TRIALS/001/2012

Identifier Type: -

Identifier Source: org_study_id

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