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

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ClinicalTrials.gov Identifier: NCT02150460
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
National Eye Centre, Kaduna

Brief 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.


Condition or disease Intervention/treatment Phase
Anaesthesia Cataract Procedure: One-site peribulbar injection Procedure: Two- site peribulbar injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: 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
Procedure: One-site peribulbar injection
injection into the inferior medial orbital compartment

Active Comparator: 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
Procedure: Two- site peribulbar injection
Two injections into the infero-temporal and supero-nasal orbital compartments




Primary Outcome Measures :
  1. Time Taken to Achieve Adequate Akinesia [ Time Frame: 10 minutes and 15 minutes ]
    Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.

  2. Supplementary Injection(s) [ Time Frame: 5 minutes ]
    After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later

  3. Complications of Local Anaesthetic Injection [ Time Frame: 0,10 and 15 minutes ]

    Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc

    Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc


  4. Pain Score for Local Anaesthetic Injection [ Time Frame: 20 minutes ]
    Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain

  5. Pain Score for Cataract Surgery [ Time Frame: 20 minutes ]
    Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain


Secondary Outcome Measures :
  1. Volume of Anaesthetic Drug (ml) [ Time Frame: 10 and 15 minutes ]
    Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery

  2. Total Number of Injections [ Time Frame: 15 minutes ]
    Total number of injections required to achieve an akinesia score of <4

  3. Surgeon Satisfaction Score for Local Anaesthetic Block [ Time Frame: 20 minutes ]
    Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)

  4. Acceptability of the Anaesthetic Block to the Subject [ Time Frame: 25 minutes ]
    Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye

  5. Duration of Cataract Surgery (Minutes) [ Time Frame: At the end of surgery ]
    Time interval from conjunctival incision to application of eye pad



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150460


Locations
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Nigeria
National Eye Centre
Kaduna, Nigeria, 800001
Sponsors and Collaborators
National Eye Centre, Kaduna
Investigators
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Principal Investigator: Aminatu A AbdulRahman, MBBS, FWACS National Eye Centre, Kaduna
Study Chair: Mahmoud B Alhassan, MBBS, FWACS National Eye Centre, Kaduna

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Responsible Party: National Eye Centre, Kaduna
ClinicalTrials.gov Identifier: NCT02150460     History of Changes
Other Study ID Numbers: NECKAD/TRIALS/001/2012
First Posted: May 29, 2014    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: May 2014
Keywords provided by National Eye Centre, Kaduna:
ophthalmic surgery, peribulbar local anaesthesia
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs