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

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

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 Overview

• Status: Completed
• Conditions: Anaesthesia; Cataract
• Intervention / Treatment: Procedure: One-site peribulbar injection; Procedure: Two- site peribulbar injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nigeria
  • Kaduna, Nigeria, 800001
    • National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: One-site peribulbar injection; injection into the inferior medial orbital compartment
ACTIVE_COMPARATOR: 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	Procedure: Two- site peribulbar injection; Two injections into the infero-temporal and supero-nasal orbital compartments

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Eye Centre, Kaduna
• Investigators: Principal Investigator: Aminatu A AbdulRahman, MBBS, FWACS, National Eye Centre, Kaduna; Study Chair: Mahmoud B Alhassan, MBBS, FWACS, National Eye Centre, Kaduna

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 26, 2014
• First Posted (ESTIMATE): May 29, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 15, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: ophthalmic surgery, peribulbar local anaesthesia
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: NECKAD/TRIALS/001/2012