Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212745220111 Date of Approval: 12/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of alkalinised and non- alkalinised peribulbar anaesthesia in attaining akinesia among patients undergoing cataract surgery: a randomised controlled trial
Official scientific title Comparison of alkalinised and non- alkalinised peribulbar anaesthesia in attaining akinesia among patients undergoing cataract surgery: a randomised controlled trial
Brief summary describing the background and objectives of the trial To compare injection perception pain, time of onset and duration of akinesia and anaesthesia between alkalinised (lignocaine with adrenaline, bupivacaine, sodium bicarbonate) and non-alkalinised (lignocaine with adrenaline, bupivacaine, sodium bicarbonate) local anaesthetic agents among patients undergoing cataract surgery at Lagos University Teaching Hospital Lagos and St Mary's Catholic Eye Hospital Ago- Iwoye.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial To reduce injection pain perception, to shorten the period of onset of akinesia, anaesthesia and the prolong duration of akinesia and anaesthesia.
Anticipated trial start date 01/12/2022
Actual trial start date
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 224
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group alkalinised group 3mls of (2% lignocaine with adrenaline 1: 200000 and 1ml of 7.5% sodium bicarbonate in 30mls of lignocaine) and 2mls of 0.5% bupivacaine its a one off intervention needed prior to cataract surgery. it is given during peribulbar anaesthesia (a type of local anaesthesia) the alkalinised arm will have 3mls of (2% lignocaine with adrenaline 1: 200000 and 1ml of 7.5% sodium bicarbonate in 30mls of lignocaine) and 2mls of 0.5% bupivacaine. the non- alkalinised arm will have 3mls of (2% lignocaine with adrenaline 1:200000) and 2mls of 0.5% bupivacaine. 112
Control Group non alkalinised group 3mls of (2% lignocaine with adrenaline 1: 200000) and 2mls of 0.5% bupivacaine. its a one off intervention. its given as a local anaesthetic agent prior to cataract surgery the non- alkalinised arm will have 3mls of (2% lignocaine with adrenaline 1: 200000) and 2mls of 0.5% bupivacaine. 112 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 40 years and above with operable cataract booked for elective cataract surgery under local anaesthesia patients with an only eye allergy to any of the medications to be used axial length greater than 26mm patients with neurological manifestations patients unable to follow instructions patients with cognitive impairment active cardiac or respiratory disease poor communication ability such as deafness patient with excessive tremors and agitations 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/12/2022 Lagos state university teaching hospital
Ethics Committee Address
Street address City Postal code Country
Idi araba lagos Nigeria 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome injection pain perception, onset and duration of akinesia and anaesthesia are primary outcome measures while secondary outcome measures will be complications of anaesthesia and onset of post operative pain 0min, 2mins, 5mins, 10mins, 30mins, every 30mins thereafter
Secondary Outcome complications from anaesthesia and onset of post operative pain intraoperatively and every 30mins after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Lagos Nigeria and St Mary Catholic Eye Hospital Ago Iwoye Ogun state Ishaga road Idi Araba, Lagos Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 14, Ekololu street off Itire Surulere Lagos State Lagos 101283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gbemisola Borisade 14, Ekolou street off Itire Surulere Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gbemisola Borisade gbemie001@yahoo.com +2347033125587 14 Ekololu street, off Itire, Sureulere Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Opeyemi Borisade borisadeope@yahoo.com +2348063354533 14 Ekololu street, off Itire, Sureulere Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Accountant
Role Name Email Phone Street address
Scientific Enquiries Olufisayo Aribaba tade.aribaba@outlook.com +2348023121710 Department of Ophthalmology, Lagos University Teaching Hospital Idi Araba Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria consultant and supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data of participants will be made available with all the results after de-identification will be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12months of completion of the study it will be available online to everyone. Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information