A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
- Conditions
- AnaesthesiaCataract
- Registration Number
- NCT02150460
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Age 50 years and above
- Diagnosed with uncomplicated senile cataract
- Visual acuity of <3/60
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Score for Cataract Surgery 20 minutes Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
Time Taken to Achieve Adequate Akinesia 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.
Supplementary Injection(s) 5 minutes After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later
Complications of Local Anaesthetic Injection 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 etcPain Score for Local Anaesthetic Injection 20 minutes Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
- Secondary Outcome Measures
Name Time Method Total Number of Injections 15 minutes Total number of injections required to achieve an akinesia score of \<4
Volume of Anaesthetic Drug (ml) 10 and 15 minutes Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Surgeon Satisfaction Score for Local Anaesthetic Block 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%)
Acceptability of the Anaesthetic Block to the Subject 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
Duration of Cataract Surgery (Minutes) At the end of surgery Time interval from conjunctival incision to application of eye pad
Trial Locations
- Locations (1)
National Eye Centre
🇳🇬Kaduna, Nigeria
National Eye Centre🇳🇬Kaduna, Nigeria