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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
injection into the inferior medial orbital compartment
Two injections into the infero-temporal and supero-nasal orbital compartments
National Eye Centre
Kaduna, Kaduna State, Nigeria
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 minutes
Volume of Anaesthetic Drug (ml)
Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Time frame: 10 and 15 minutes
Total Number of Injections
Total number of injections required to achieve an akinesia score of \<4
Time frame: 15 minutes
Surgeon Satisfaction Score for Local Anaesthetic Block
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%)
Time frame: 20 minutes
Acceptability of the Anaesthetic Block to the Subject
Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye
Time frame: 25 minutes
Duration of Cataract Surgery (Minutes)
Time interval from conjunctival incision to application of eye pad
Time frame: At the end of surgery
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