A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 26, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedResults Posted
Study results publicly available
March 17, 2015
CompletedMarch 17, 2015
May 1, 2014
2 months
May 26, 2014
February 13, 2015
March 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Time Taken to Achieve Adequate Akinesia
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.
10 minutes and 15 minutes
Supplementary Injection(s)
After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later
5 minutes
Complications of Local Anaesthetic Injection
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
0,10 and 15 minutes
Pain Score for Local Anaesthetic Injection
Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
20 minutes
Pain Score for Cataract Surgery
Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
20 minutes
Secondary Outcomes (5)
Volume of Anaesthetic Drug (ml)
10 and 15 minutes
Total Number of Injections
15 minutes
Surgeon Satisfaction Score for Local Anaesthetic Block
20 minutes
Acceptability of the Anaesthetic Block to the Subject
25 minutes
Duration of Cataract Surgery (Minutes)
At the end of surgery
Study Arms (2)
One-site peribulbar injection
EXPERIMENTALInjection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment
Two-site peribulbar injection
ACTIVE COMPARATORInjection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments
Interventions
injection into the inferior medial orbital compartment
Two injections into the infero-temporal and supero-nasal orbital compartments
Eligibility Criteria
You may qualify if:
- Age 50 years and above
- Diagnosed with uncomplicated senile cataract
- Visual acuity of \<3/60
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Eye Centre
Kaduna, Kaduna State, 800001, Nigeria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Aminatu Ali AbdulRahman
- Organization
- National Eye Centre, Kaduna. Nigeria
Study Officials
- PRINCIPAL INVESTIGATOR
Aminatu A AbdulRahman, MBBS, FWACS
National Eye Centre, Kaduna
- STUDY CHAIR
Mahmoud B Alhassan, MBBS, FWACS
National Eye Centre, Kaduna
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2014
First Posted
May 29, 2014
Study Start
October 1, 2012
Primary Completion
December 1, 2012
Study Completion
June 1, 2013
Last Updated
March 17, 2015
Results First Posted
March 17, 2015
Record last verified: 2014-05