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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150460
• Other study ID #: NECKAD/TRIALS/001/2012
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2014
• Last updated: March 15, 2015
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: National Eye Centre, Kaduna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: National Agency For Food and Drug Administration and Control
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Cataract

Intervention

Procedure:
• One-site peribulbar injection
injection into the inferior medial orbital compartment
• Two- site peribulbar injection
Two injections into the infero-temporal and supero-nasal orbital compartments

Locations

Country	Name	City	State
Nigeria	National Eye Centre	Kaduna

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Centre, Kaduna

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	Total Number of Injections	Total number of injections required to achieve an akinesia score of <4	15 minutes	Yes
Secondary	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	No
Secondary	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	No
Secondary	Duration of Cataract Surgery (Minutes)	Time interval from conjunctival incision to application of eye pad	At the end of surgery	No