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.: PACTR201810828658359 Date of Registration: 10/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between mepivacaine versus bupivacaine in percutaneous single injection peribulbar injection with short needle in cataract surgery
Official scientific title Comparison between mepivacaine versus bupivacaine in peribulbar injection with short needle in cataract surgery
Brief summary describing the background and objectives of the trial The aim of this study was to estimate the effectiveness and safety of a percutaneous peribulbar single injection technique and compare orbital muscle akinesia caused by mepivacaine in comparison with bupivacaine when added with the lidocaine and hyaluronidase in single‑injection peribulbar anesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/10/2018
Actual trial start date 15/10/2018
Anticipated date of last follow up 15/01/2019
Actual Last follow-up date 15/01/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group peribulbar block Patients were assigned to receive 6-8 ml combination of equal parts bupivacaine 0.5% and lidocaine 2% (B group) with hyaluronidase 25 IU/mL. single injection peribulbar block 45 Dose Comparison
Experimental Group peribulbar block Patients were assigned to receive 6-8 ml combination of equal parts mepivacaine 3% and lidocaine 2% (M group) with hyaluronidase 25 IU/mL. single injection peribulbar block 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
90 aged patients listed for cataract surgery with an expected duration of less than 60 min patients younger than 21 years , patients refusing local anesthesia , those with single eye , ocular infection , and when the decubitus position was difficult . Patients with communication problems , impaired consciousness , coagulopathy , and mental retardation, were also disqualified from the study. Aged: 65+ Year(s) 65 Year(s) 75 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 21/03/2018 AIN shams university research ethics committee
Ethics Committee Address
Street address City Postal code Country
abbasyia cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to estimate the effectiveness and safety of a percutaneous peribulbar single injection technique and compare orbital muscle akinesia caused by mepivacaine in comparison with bupivacaine when added with the lidocaine and hyaluronidase in single‑injection peribulbar anesthesia 2,5,10 and 15 min after the block
Secondary Outcome lid hematoma, chemosis, eye perforation,optic nerve injury after the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital abbasyia street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ashraf Nabil fifth settlement cairo 11835 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ashraf nabil street 38 cairo 11835 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator wail abdelaal wailabdelaal64@yahoo.com +01067499156 madinaty
City Postal code Country Position/Affiliation
cairo 19519 Egypt assistant professor of anesthesia ain shams university
Role Name Email Phone Street address
Public Enquiries ashraf saleh ashraf_nabel@med.asu.edu.eg +201001100613 fifth settlement
City Postal code Country Position/Affiliation
cairo 11835 Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Scientific Enquiries milad zekry miladrgaei@yahoo.com +20122421930 shubra
City Postal code Country Position/Affiliation
cairo 11672 Egypt lecturer of anesthesia ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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