Anaesthesia, Cataract
Conditions
Keywords
ophthalmic surgery, peribulbar local anaesthesia
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.
Interventions
PROCEDUREOne-site peribulbar injection
injection into the inferior medial orbital compartment
PROCEDURETwo- site peribulbar injection
Two injections into the infero-temporal and supero-nasal orbital compartments
Sponsors
National Eye Centre, Kaduna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score for Cataract Surgery | 20 minutes | Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain |
| Time Taken to Achieve Adequate Akinesia | 10 minutes and 15 minutes | 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) | 5 minutes | 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 | 0,10 and 15 minutes | 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 | 20 minutes | Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Anaesthetic Drug (ml) | 10 and 15 minutes | Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery |
| Total Number of Injections | 15 minutes | Total number of injections required to achieve an akinesia score of \<4 |
| Surgeon Satisfaction Score for Local Anaesthetic Block | 20 minutes | 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 | 25 minutes | 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) | At the end of surgery | Time interval from conjunctival incision to application of eye pad |
Countries
Nigeria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | One-site Peribulbar Injection | Two-site Peribulbar Injection | Total |
|---|---|---|---|
| Age, Continuous | 64.30 years STANDARD_DEVIATION 7.4 | 62.60 years STANDARD_DEVIATION 10.7 | 63.45 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 29 Participants | 27 Participants | 56 Participants |
| Weight (kg) | 61.48 kilogram STANDARD_DEVIATION 13 | 57.38 kilogram STANDARD_DEVIATION 10.3 | 59.26 kilogram STANDARD_DEVIATION 11.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 14 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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
Time frame: 0,10 and 15 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Complications of Local Anaesthetic Injection | Deviation of the globe | 1 participants |
| Group 1 | Complications of Local Anaesthetic Injection | Sunconjunctival haemorrhage | 0 participants |
| Group 1 | Complications of Local Anaesthetic Injection | Chemosis | 0 participants |
| Group 2 | Complications of Local Anaesthetic Injection | Deviation of the globe | 0 participants |
| Group 2 | Complications of Local Anaesthetic Injection | Sunconjunctival haemorrhage | 1 participants |
| Group 2 | Complications of Local Anaesthetic Injection | Chemosis | 14 participants |
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
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Pain Score for Cataract Surgery | 1.06 units on a scale | Standard Deviation 0.2 |
| Group 2 | Pain Score for Cataract Surgery | 1.06 units on a scale | Standard Deviation 0.6 |
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
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Pain Score for Local Anaesthetic Injection | 1.64 units on a scale | Standard Deviation 0.6 |
| Group 2 | Pain Score for Local Anaesthetic Injection | 1.58 units on a scale | Standard Deviation 0.6 |
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
Time frame: 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Supplementary Injection(s) | 9 participants |
| Group 2 | Supplementary Injection(s) | 9 participants |
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.
Time frame: 10 minutes and 15 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Time Taken to Achieve Adequate Akinesia | 15 minutes | 9 participants |
| Group 1 | Time Taken to Achieve Adequate Akinesia | 10 minutes | 41 participants |
| Group 2 | Time Taken to Achieve Adequate Akinesia | 15 minutes | 9 participants |
| Group 2 | Time Taken to Achieve Adequate Akinesia | 10 minutes | 41 participants |
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
Time frame: 25 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Acceptability of the Anaesthetic Block to the Subject | 50 participants |
| Group 2 | Acceptability of the Anaesthetic Block to the Subject | 50 participants |
Secondary
Duration of Cataract Surgery (Minutes)
Time interval from conjunctival incision to application of eye pad
Time frame: At the end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Duration of Cataract Surgery (Minutes) | 8.78 minutes | Standard Deviation 2.19 |
| Group 2 | Duration of Cataract Surgery (Minutes) | 8.88 minutes | Standard Deviation 2.4 |
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%)
Time frame: 20 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Surgeon Satisfaction Score for Local Anaesthetic Block | 4 units on a scale |
| Group 2 | Surgeon Satisfaction Score for Local Anaesthetic Block | 4 units on a scale |
Secondary
Total Number of Injections
Total number of injections required to achieve an akinesia score of \<4
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Total Number of Injections | 1.18 injections | Standard Deviation 0.39 |
| Group 2 | Total Number of Injections | 2.18 injections | Standard Deviation 0.39 |
Secondary
Volume of Anaesthetic Drug (ml)
Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Time frame: 10 and 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Volume of Anaesthetic Drug (ml) | 5.36 milliliters | Standard Deviation 0.78 |
| Group 2 | Volume of Anaesthetic Drug (ml) | 5.40 milliliters | Standard Deviation 0.88 |