Trial Outcomes & Findings for A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria (NCT NCT02150460)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

10 minutes and 15 minutes

Results posted on

2015-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One-site Peribulbar Injection n=50 Participants 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	Two-site Peribulbar Injection n=50 Participants 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	Total n=100 Participants Total of all reporting groups
Age, Continuous	64.30 years STANDARD_DEVIATION 7.4 • n=5 Participants	62.60 years STANDARD_DEVIATION 10.7 • n=7 Participants	63.45 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Weight (kg)	61.48 kilogram STANDARD_DEVIATION 13.0 • n=5 Participants	57.38 kilogram STANDARD_DEVIATION 10.3 • n=7 Participants	59.26 kilogram STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Time Taken to Achieve Adequate Akinesia 10 minutes	41 participants	41 participants
Time Taken to Achieve Adequate Akinesia 15 minutes	9 participants	9 participants

PRIMARY outcome

Timeframe: 5 minutes

After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Supplementary Injection(s)	9 participants	9 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Complications of Local Anaesthetic Injection Deviation of the globe	1 participants	0 participants
Complications of Local Anaesthetic Injection Sunconjunctival haemorrhage	0 participants	1 participants
Complications of Local Anaesthetic Injection Chemosis	0 participants	14 participants

PRIMARY outcome

Timeframe: 20 minutes

Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Pain Score for Local Anaesthetic Injection	1.64 units on a scale Standard Deviation 0.6	1.58 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 20 minutes

Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Pain Score for Cataract Surgery	1.06 units on a scale Standard Deviation 0.2	1.06 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 10 and 15 minutes

Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Volume of Anaesthetic Drug (ml)	5.36 milliliters Standard Deviation 0.78	5.40 milliliters Standard Deviation 0.88

SECONDARY outcome

Timeframe: 15 minutes

Total number of injections required to achieve an akinesia score of \<4

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Total Number of Injections	1.18 injections Standard Deviation 0.39	2.18 injections Standard Deviation 0.39

SECONDARY outcome

Timeframe: 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%)

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Surgeon Satisfaction Score for Local Anaesthetic Block	4 units on a scale Interval 1.0 to 4.0	4 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Acceptability of the Anaesthetic Block to the Subject	50 participants	50 participants

SECONDARY outcome

Timeframe: At the end of surgery

Time interval from conjunctival incision to application of eye pad

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants One-site peribulbar injection	Group 2 n=50 Participants Two-site peribulbar injection
Duration of Cataract Surgery (Minutes)	8.78 minutes Standard Deviation 2.19	8.88 minutes Standard Deviation 2.40

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 n=50 participants at risk One-site peribulbar injection	Group 2 n=50 participants at risk Two-site peribulbar injection
Eye disorders Chemosis	0.00% 0/50 • 3 months	28.0% 14/50 • Number of events 14 • 3 months

Additional Information

Dr Aminatu Ali AbdulRahman

National Eye Centre, Kaduna. Nigeria

Phone: +2348037878367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place