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.: PACTR201903779653918 Date of Approval: 11/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative effect of local anesthesia with lidocaine 2% versus topical anesthesia on cognitive function in patients undergoing elective cataract surgery
Official scientific title Effect of local anesthesia with lidocaine 2% versus topical anesthesia on cognitive function in patients undergoing elective cataract surgery
Brief summary describing the background and objectives of the trial The effect of anaesthetic drugs on cognitive function was previously demostrated by multiple studies.The aim of this works is to compare the effect of local versus topical anesthesia on cognitive function
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 Early detection /Screening
Anticipated trial start date 01/05/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 28/02/2019
Actual Last follow-up date 28/02/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Topical anesthesia 2 drops every 90 sec 3 times before the surgery 30 min 2 eye drops every 90 sec 3 times before the surgery 30 Active-Treatment of Control Group
Experimental Group peribulbar block lidocaine 2% (total volume 7 ml) with hyaluorindase 15 IU (30 participants) 2 hours peribulbar injection technique will be used with a 25-mm 25-G needle using complete antiseptic technique, injection of a volume 4 ml inferolaterally after negative aspiration with the patients looking straight ahead and 3 ml through the medial canthus. The inferolateral injection will be performed before the medial canthal injection. Digital pressure was applied for 5 minutes which was released every 30 seconds for 5 seconds. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients candidate for elective cataract surgery by phacoemulsification 2. The patients should provide signed written informed consent to participate. 1. Patients with major language disturbance or auditory impairment affecting their ability to complete testing 2. Patients with pre-existing cognitive, psychiatric or central nervous system disorders 3. Patients with nystagmus, 4. Patients with allergy to local or topical anaesthetics 5. Patients with any coexisting ocular conditions that could affect the scoring system for local anaesthesia such as ptosis, ocular movement abnormality, reduced corneal sensation, or facial nerve palsy 6. Inability to understand the information about the study 7. if the patient refused the local or topical anaesthesia technique Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 24/04/2018 faculty of medicine beni suef university
Ethics Committee Address
Street address City Postal code Country
Beni suef Mokbel street Beni suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognitive function one week
Secondary Outcome Patient satisfaction During the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni suef university hospital Salah Salem street Beni suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Salah Salem street Beni suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university hospital Salah salem street Beni suef 62511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mona Hussein Salah Salem street Beni suef 62511 Egypt
Hossam Khalil Khalil Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Fathy drwaelfathy@yahoo.com 01006527133 Beni suef Elabasiri street
City Postal code Country Position/Affiliation
Benisuef 62511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mona Hussein Mona.neuro@yahoo.com 01005131318 Salah Salem street
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Hossam Khalil Khalil_hossam@hotmail.com 01227458864 masr elgededa
City Postal code Country Position/Affiliation
Cairo Egypt assistant proff
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes cognitive tests Informed Consent Form 1 year controlled access sharing the data by email the corresponding author is responsible for reviewing the requests
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318706/ Yes Regarding cognitive assessment of patients in lidocaine group, there was a statistically significant difference between the mean value of preoperative PALT and postoperative PALT (P-value =0.004), and between the mean value of preoperative VF and postoperative VF (P-value =0.002). As for bupivacaine group, there was a statistically significant difference between the mean value of preoperative PALT and postoperative PALT (P-value =0.021), and between the mean value of preoperative VF and postoperative VF (P-value =0.037). On comparing lidocaine and bupivacaine groups in pre and postoperative PALT & VF scores, there was no statistically significant difference between both groups 01/12/2018 31/12/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318706/
Changes to trial information