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

Phase 4

Completed

Interventions: Procedure: One-site peribulbar injection
Procedure: Two- site peribulbar injection

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
One-site peribulbar injection	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
Two-site peribulbar injection	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

Primary Outcome Measures

Name	Time	Method
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 etc
Pain 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
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

Secondary Outcome Measures

Name	Time	Method
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
Total Number of Injections	15 minutes	Total number of injections required to achieve an akinesia score of \<4
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