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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria

Conditions
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Anaesthesia, Cataract

Intervention / Treatment
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* Procedure: One-site peribulbar injection
* Procedure: Two- site peribulbar injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-site peribulbar injection<br>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<br>* injection into the inferior medial orbital compartment<br>|
| Active Comparator: Two-site peribulbar injection<br>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<br>* Two injections into the infero-temporal and supero-nasal orbital compartments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Anaesthetic Drug (ml) | Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery | 10 and 15 minutes | 
| Total Number of Injections | Total number of injections required to achieve an akinesia score of <4 | 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%) | 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 | 25 minutes | 
| Duration of Cataract Surgery (Minutes) | Time interval from conjunctival incision to application of eye pad | At the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ophthalmic surgery, peribulbar local anaesthesia