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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: www.pactr.org

Trial no.: PACTR201305000512337 Date registered: 2013/03/08
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
Purpose of the trial Treatment
Anticipated trial start date 2013-03-11
Actual trial start date
Anticipated date of last follow up 2013-10-08
Actual date of last follow up
Anticipated target sample size (number of participants) 100   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group peribulbar 5 milliliter 10 minutes Anaesthesia 50
Experimental group Subtenon Anaesthesia 5 mililiter 10 minutes Anasthesia 50

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 90 Years 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 Fax
Scientific Enquiries Dr Bola Adekoya bjadekoya2007@yahoo.com +2348033817215
Street address City Postal code Country Position / Affiliation
No 1-5 Oba Akinjobi street GRA Ikeja Lagos Nigeria Consultant Ophthalmologist
Role Name Email Phone Fax
Principal Investigator Dr Rosemary Ngwu vicsom2000@yahoo.com +2348035641015
Street address City Postal code Country Position / Affiliation
1-5 Oba Akinjobi Street GRA Ikeja Lagos Lagos +234 Nigeria Senior Registrar
Role Name Email Phone Fax
Public Enquiries Dr Olumide Adejumo drolus_adejumo@yahoo.com +2348033502773
Street address City Postal code Country Position / Affiliation
1-5 Oba Akinjobi Street GRA Ikeja Lagos Lagos +234 Nigeria Lagos State University TEaching Hospital