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
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2012-10-31
2013-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
One-site peribulbar injection
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
Two- site peribulbar injection
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
Two- site peribulbar injection
Two injections into the infero-temporal and supero-nasal orbital compartments
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with uncomplicated senile cataract
* Visual acuity of \<3/60
Exclusion Criteria
* 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
50 Years
ALL
Yes
Sponsors
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National Eye Centre, Kaduna
OTHER_GOV
Responsible Party
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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
Countries
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Other Identifiers
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NECKAD/TRIALS/001/2012
Identifier Type: -
Identifier Source: org_study_id
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