AnaesthesiaPhase 4NCT02150460
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
A Phase 4 study testing One-site peribulbar injection and Two- site peribulbar injection in people with Anaesthesia and Cataract, run by National Eye Centre, Kaduna at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia, Cataract
- What is being tested?
- One-site peribulbar injection and Two- site peribulbar injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- Oct 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 years and above
- Diagnosed with uncomplicated senile cataract
- Visual acuity of <3/60
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
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.
- Conditions
- Anaesthesia, Cataract
- Being tested
- One-site peribulbar injection, Two- site peribulbar injection
- Keywords
- ophthalmic surgery, peribulbar local anaesthesia
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-site peribulbar injectionProcedure or surgery
injection into the inferior medial orbital compartment
Two- site peribulbar injectionProcedure or surgery
Two injections into the infero-temporal and supero-nasal orbital compartments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: One-site peribulbar injection |
| 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 Receives: Procedure: Two- site peribulbar injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 20 minutes
Secondary outcomes (5)
Volume of Anaesthetic Drug (ml)
Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery
Measured: 10 and 15 minutes
Total Number of Injections
Total number of injections required to achieve an akinesia score of <4
Measured: 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%)
Measured: 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
Measured: 25 minutes
Duration of Cataract Surgery (Minutes)
Time interval from conjunctival incision to application of eye pad
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Centre, Kaduna
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aminatu A AbdulRahman, MBBS, FWACS, Principal investigator, National Eye Centre, KadunaMahmoud B Alhassan, MBBS, FWACS, Study chair, National Eye Centre, Kaduna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150460
- Sponsor's protocol ID
- NECKAD/TRIALS/001/2012
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
- ClinicalTrials.gov ID
- NCT02150460
- Acronym / sponsor ID
- NECKAD/TRIALS/001/2012
- Conditions
- Anaesthesia, Cataract
- Keywords
- ophthalmic surgery, peribulbar local anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Eye Centre, KadunaOther government
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-site peribulbar injection | Experimental | Procedure: One-site peribulbar injectionInjection 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 | Procedure: Two- site peribulbar injectionInjection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 years and above
- Diagnosed with uncomplicated senile cataract
- Visual acuity of <3/60
Key exclusion criteria (8 listed)
- Impaired mental status
- Difficulty in speaking
- Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
- Previous surgery in the same eye
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-site peribulbar injectioninjection into the inferior medial orbital compartment | Procedure or surgery | One-site peribulbar injection |
| Two- site peribulbar injectionTwo injections into the infero-temporal and supero-nasal orbital compartments | Procedure or surgery | Two-site peribulbar injection |
Primary outcome
Time Taken to Achieve Adequate Akinesia
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 20 minutes
Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
Pain Score for Cataract Surgery
Time frame: 20 minutes
Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
5 secondary outcomes
Volume of Anaesthetic Drug (ml)
Time frame: 10 and 15 minutes
Total Number of Injections
Time frame: 15 minutes
Surgeon Satisfaction Score for Local Anaesthetic Block
Time frame: 20 minutes
Acceptability of the Anaesthetic Block to the Subject
Time frame: 25 minutes
Duration of Cataract Surgery (Minutes)
Time frame: At the end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminatu A AbdulRahman, MBBS, FWACS principal investigator
National Eye Centre, Kaduna
Mahmoud B Alhassan, MBBS, FWACS study chair
National Eye Centre, Kaduna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing One-site peribulbar injection and Two- site peribulbar injection in people with Anaesthesia and Cataract, run by National Eye Centre, Kaduna at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Taken to Achieve Adequate Akinesia (time frame: 10 minutes and 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.