Phase 4
N=100
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
Anaesthesia · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02150460 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Time Taken to Achieve Adequate Akinesia — 41; 41; 9; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- One-site peribulbar injection (Procedure); Two- site peribulbar injection (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- National Eye Centre, Kaduna
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken to Achieve Adequate Akinesia |
41; 41; 9; 9 | — |
| PRIMARY Supplementary Injection(s) |
9; 9 | — |
| PRIMARY Complications of Local Anaesthetic Injection |
1; 0; 0; 1; 0; 14 | — |
| PRIMARY Pain Score for Local Anaesthetic Injection |
1.64; 1.58 | — |
| PRIMARY Pain Score for Cataract Surgery |
1.06; 1.06 | — |
| SECONDARY Volume of Anaesthetic Drug (ml) |
5.36; 5.40 | — |
| SECONDARY Total Number of Injections |
1.18; 2.18 | — |
| SECONDARY Surgeon Satisfaction Score for Local Anaesthetic Block |
4; 4 | — |
| SECONDARY Acceptability of the Anaesthetic Block to the Subject |
50; 50 | — |
| SECONDARY Duration of Cataract Surgery (Minutes) |
8.78; 8.88 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02150460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.