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.: PACTR201305000512337 Date of Approval: 08/03/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF SUBTENON WITH PERIBULBAR ANAESTHESIA FOR CATARACT SURGERIES : A RANDOMIZED CONTROLLED TRIAL .
Official scientific title COMPARISON OF SUBTENON WITH PERIBULBAR ANAESTHESIA FOR CATARACT SURGERIES : A RANDOMIZED CONTROLLED TRIAL .
Brief summary describing the background and objectives of the trial Anaesthetic management may contribute to the success or failure of ophthalmic surgery. The anaesthesia used for these surgeries has been evolving over the years. Current options include retrobulbar, peribulbar, subconjunctival, topical and subtenon¿s anaesthesia. This study is aimed at comparing the safety and efficacy of Subtenon with peribulbar anaesthesia in cataract surgeries done at Lagos State University Teaching Hospital Ikeja Lagos.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cataract,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/03/2013
Actual trial start date 01/05/2013
Anticipated date of last follow up 08/10/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using the sequentially numbered opaque sealed envelopes Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Subtenon Anaesthesia 5 mililiter 10 minutes Anasthesia 50
Control Group peribulbar 5 milliliter 10 minutes Anaesthesia 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting patients > 18years undergoing elective surgery for uncomplicated cataract at Lagos State University Teaching Hospital, Ikeja, Lagos 1. Age < 18 yrs or > 90 yrs 2. Known sensitivity to the anaesthetic agent 3. Active ocular infection or inflammation 4. Uncontrolled glaucoma 5. History of convulsion or epilepsy 6. Previous intraocular injury, inflammation or surgery 7. Inability to give informed consent 8. Traumatic cataract 18 Year(s) 90 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 Lagos State University Teaching Hospital Health Research and Ethics Committe
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi street GRA Ikeja Lagos +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Pain during administration, intra and post operatively
Primary Outcome Akinesia Akinesia at 2 minutes , 5 minutes and 10 minutes
Secondary Outcome Intraocular pressure pre administration of anaesthesia, I minute after administration of anaesthesia 5 minutes after administration of anaesthesia 10 minutes after administration of anaesthesia
Secondary Outcome chemosis immediately before surgery
Secondary Outcome Subconjuctival heamorrhage immediately before surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University teaching Hospital 1-5 Oba Akinjobi Street GRA Ikeja Lagos +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lagos State University Teaching Hospital 1-5 Oba Akinjobi Street GRA Ikeja Lagos +234 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Adekoya B. J 1-5 Oba Akinjobi Street GRA Ikeja Lagos +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosemary Ngwu vicsom2000@yahoo.com +2348035641015 1-5 Oba Akinjobi Street GRA Ikeja Lagos
City Postal code Country Position/Affiliation
Lagos +234 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olumide Adejumo drolus_adejumo@yahoo.com +2348033502773 1-5 Oba Akinjobi Street GRA Ikeja Lagos
City Postal code Country Position/Affiliation
Lagos +234 Nigeria Lagos State University TEaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Bola Adekoya bjadekoya2007@yahoo.com +2348033817215 No 1-5 Oba Akinjobi street GRA Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant Ophthalmologist
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information