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

NCT02150460 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-03-17

Study results available
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Summary

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.

Conditions

  • Anaesthesia
  • Cataract

Interventions

PROCEDURE

One-site peribulbar injection

injection into the inferior medial orbital compartment

PROCEDURE

Two- site peribulbar injection

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

Sponsors & Collaborators

  • National Eye Centre, Kaduna

    lead OTHER_GOV

Principal Investigators

  • Aminatu A AbdulRahman, MBBS, FWACS · National Eye Centre, Kaduna

  • Mahmoud B Alhassan, MBBS, FWACS · National Eye Centre, Kaduna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150460 on ClinicalTrials.gov