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.: PACTR201503001062685 Date of Approval: 08/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Articaine versus Bupivacaine / Lidocaine mixture in episcleral peribulbar anesthesia for cataract surgery. A prospective randomized controlled study.
Official scientific title 80 patients of both sexes undergoing elective cataract surgery with peribulbar episcleral anesthesia. Patients will be randomly allocated into two groups, 40 patients each. Group A: 40 patients will receive peribulbar episcleral anesthesia using 2% articaine as a local anesthetic agent. Group B: 40 patients will receive peribulbar episcleral anesthesia using a mixture of 0.5% bupivacaine and 2% Li
Brief summary describing the background and objectives of the trial Medial episcleral peribulbar anesthesia has been shown to be a valid alternative for ocular regional anesthesia, because of the infrequent complications observed. The site of injection is relatively a vascular. Articaine is a new local anesthetic drug used in eye surgery with dense motor block and fewer complications. The current study demonstrates that peribulbar episcleral technique with 2% articaine and epinephrine 5ug/ml was effective and provide a superior option to a mixture of 0.5% bupivacaine/ 2%lidocaine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,cataract surgery,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/03/2015
Actual trial start date 16/03/2015
Anticipated date of last follow up 12/05/2015
Actual Last follow-up date 10/03/2015
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
Recruitment status 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 Sealed envelopes were numbered according to the randomization tables. - Packing, sealing and numbering of the envelops was performed by a neutral medical personnel (Under the supervision of doctors from the Department of Anesthesiology). Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 8 ml. articaine 2% in 1:200 000 epinephrine without hyaluronidase. we use 25-gauge, 25-mm cutting bevel disposable needle (Atkinson needle);followed by external compression with the Honan balloon for 5 minutes after injection. The injection will be done while the eye is in the neutral position, the needle will be inserted percutaneously in the anteroposterior direction perpendicular to the frontal plane and parallel to the sagittal plane in the inferomedial point 30
Control Group Group B equal volume of lidocaine 2% (4ml) and Bupivacaine 0.5% (4ml) with total 8 ml. mixture without hyaluronidase. We use a 25-gauge,25-mm cutting bevel disposable needle (Atkinson needle); followed by external compression with the Honan balloon for 5 minutes after injection.The injection will be done while the eye is in the neutral position,the needle will be inserted percutaneously in the anteroposterior direction perpendicular to the frontal plane and parallel to the sagittal plane in the inferomedial point 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients scheduled to undergo an elective cataract surgery under local anesthesia. - ASA classification: I - III. - Minimum age: 30 Years - Maximum age: 80 Years - Gender: Both males and females. - Patients younger than 30 years old, - history of succinyl choline apnea, - history of allergy to amide type local anesthetics. - patient refusal or patients with communication problems. 30 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 01/02/2015 local ethical committee of faculty of medicine, Ain shams university.
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbasia district. cairo PO Box:11539 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ocular movement will be assessed using the scoring system described by Brahma and colleagues. Ocular movement was scored for each direction of gaze in the superior, inferior, medial and lateral directions, with a maximum score for each direction of 3 points and a possible total maximum of 12 points. ocular movement will be assessed at 1, 5, 10 minutes after block.
Secondary Outcome The total volume of local anesthetic required and the need for supplementary local anesthesia will be recordedImmediate complications due to the block (e.g. Sub conjunctival hemorrhage, echymosis, retrobulbar hemorrhage) were also recorded. At the end of the surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, Ain Shams university Ramsis street, Abbasia district. cairo. PO Box:11539 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams university Ramsis street, Abbasia district cairo PO Box: 11539 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university Ramsis street, Abbasia district. cairo PO Box: 11539 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Houssein 5 Abdelazem Salama street, of Makram Ebed street, Nasr City. cairo Egypt
Ibrahim Mohamed Ibrahim 8 Ismail Ibrahim street,of Elaziz Belah street, Al Zytoun. cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mostafa mansour mostafa.mansor@med.asu.edu.eg +201093322145 department of anesthesia and intensive care, faculty of medicine, Ain shams university. Ramsis street, Abbasia district, Cairo. PO Box: 11539
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg +201093322145 department of anesthesia and intensive care, faculty of medicine, Ain shams university. Ramsis street, Abbasia district, Cairo. PO Box: 11539
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg +201093322145 department of anesthesia and intensive care, faculty of medicine, Ain shams university. Ramsis street, Abbasia district, Cairo. PO Box: 11539
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
REPORTING
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