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

Primary Purpose

Anaesthesia, Cataract

Status
Completed
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
One-site peribulbar injection
Two- site peribulbar injection
Sponsored by
National Eye Centre, Kaduna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaesthesia focused on measuring ophthalmic surgery, peribulbar local anaesthesia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Eye Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One-site peribulbar injection

Two-site peribulbar injection

Arm Description

Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment

Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments

Outcomes

Primary Outcome Measures

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.
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
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
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
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

Secondary Outcome Measures

Volume of Anaesthetic Drug (ml)
Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Total Number of Injections
Total number of injections required to achieve an akinesia score of <4
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%)
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
Duration of Cataract Surgery (Minutes)
Time interval from conjunctival incision to application of eye pad

Full Information

First Posted
May 26, 2014
Last Updated
March 15, 2015
Sponsor
National Eye Centre, Kaduna
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1. Study Identification

Unique Protocol Identification Number
NCT02150460
Brief Title
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
Official Title
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Eye Centre, Kaduna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaesthesia, Cataract
Keywords
ophthalmic surgery, peribulbar local anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-site peribulbar injection
Arm Type
Experimental
Arm Description
Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment
Arm Title
Two-site peribulbar injection
Arm Type
Active Comparator
Arm Description
Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments
Intervention Type
Procedure
Intervention Name(s)
One-site peribulbar injection
Intervention Description
injection into the inferior medial orbital compartment
Intervention Type
Procedure
Intervention Name(s)
Two- site peribulbar injection
Intervention Description
Two injections into the infero-temporal and supero-nasal orbital compartments
Primary Outcome Measure Information:
Title
Time Taken to Achieve Adequate Akinesia
Description
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
Title
Supplementary Injection(s)
Description
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
Title
Complications of Local Anaesthetic Injection
Description
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
Title
Pain Score for Local Anaesthetic Injection
Description
Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
Time Frame
20 minutes
Title
Pain Score for Cataract Surgery
Description
Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Volume of Anaesthetic Drug (ml)
Description
Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Time Frame
10 and 15 minutes
Title
Total Number of Injections
Description
Total number of injections required to achieve an akinesia score of <4
Time Frame
15 minutes
Title
Surgeon Satisfaction Score for Local Anaesthetic Block
Description
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
Title
Acceptability of the Anaesthetic Block to the Subject
Description
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
Title
Duration of Cataract Surgery (Minutes)
Description
Time interval from conjunctival incision to application of eye pad
Time Frame
At the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminatu A AbdulRahman, MBBS, FWACS
Organizational Affiliation
National Eye Centre, Kaduna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmoud B Alhassan, MBBS, FWACS
Organizational Affiliation
National Eye Centre, Kaduna
Official's Role
Study Chair
Facility Information:
Facility Name
National Eye Centre
City
Kaduna
ZIP/Postal Code
800001
Country
Nigeria

12. IPD Sharing Statement

Learn more about this trial

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

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