Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-site peribulbar injection | Experimental | 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 | Active Comparator | Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-site peribulbar injection | Procedure | injection into the inferior medial orbital compartment |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aminatu A AbdulRahman, MBBS, FWACS | National Eye Centre, Kaduna | Principal Investigator |
| Mahmoud B Alhassan, MBBS, FWACS | National Eye Centre, Kaduna | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Eye Centre | Kaduna | Kaduna State | 800001 | Nigeria |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 One-site peribulbar injection: injection into the inferior medial orbital compartment |
| FG001 | 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 Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients aged 50 years and above with age related operable cataracts that presented for elective cataract surgery during the study period
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 One-site peribulbar injection: injection into the inferior medial orbital compartment |
| BG001 | Two-site Peribulbar Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 10 minutes and 15 minutes |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | One-site peribulbar injection |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chemosis | Eye disorders | Non-systematic Assessment | Swelling of the conjunctiva |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Aminatu Ali AbdulRahman | National Eye Centre, Kaduna. Nigeria | +2348037878367 | aaaminatu@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Two- site peribulbar injection | Procedure | Two injections into the infero-temporal and supero-nasal orbital compartments |
|
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 |
Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kilogram |
|
|
|
| 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 | Posted | Number | participants | 5 minutes |
|
|
|
| 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 | Posted | Number | participants | 0,10 and 15 minutes |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 20 minutes |
|
|
|
| Secondary | Volume of Anaesthetic Drug (ml) | Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery | Posted | Mean | Standard Deviation | milliliters | 10 and 15 minutes |
|
|
|
| Secondary | Total Number of Injections | Total number of injections required to achieve an akinesia score of <4 | Posted | Mean | Standard Deviation | injections | 15 minutes |
|
|
|
| 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%) | Posted | Median | Full Range | units on a scale | 20 minutes |
|
|
|
| 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 | Posted | Number | participants | 25 minutes |
|
|
|
| Secondary | Duration of Cataract Surgery (Minutes) | Time interval from conjunctival incision to application of eye pad | Posted | Mean | Standard Deviation | minutes | At the end of surgery |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 20 minutes |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Group 2 | Two-site peribulbar injection | 0 | 50 | 14 | 50 |
Not provided
Not provided
| Chemosis |
|