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.: PACTR202305574486145 Date of Approval: 10/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Of Two Different Methods as a Reliable Predictors Of Successful Caudal Block in Children
Official scientific title Comparison Of Two Different Methods as a Reliable Predictors Of Successful Caudal Block in Children
Brief summary describing the background and objectives of the trial The degree of hypotension is due to vascular tone. PI can be used to access the peripheral perfusion which can be altered due to peripheral vascular tone It is hypothesized that changes in PI after caudal block can early detect onset and success of the block. So, we decided to compare changes in heart rate after caudal block and Perfusion index to assess the onset and success of caudal block in children. To study the effectiveness of perfusion index and changes in heart rate after caudal block in assessment of onset and adequacy of caudal block in children
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/02/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 01/05/2023
Actual Last follow-up date 01/06/2023
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 100
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PI group All children will be assessed for perfusion index before caudal and every 2 minutes after caudal block. Perfusion index will be measured by masimo pulse oximeter in automated noninvasive device (Biolight M69, Biolight Meditech®, Zhuhai, China). 10 minutes All children will be assessed for perfusion index before caudal and every 2 minutes after caudal block. Perfusion index will be measured by masimo pulse oximeter in automated noninvasive device (Biolight M69, Biolight Meditech®, Zhuhai, China). 100
Control Group HR group An initial 0.2 ml/kg 0.25% bupivacaine will be injected over 3 to 4 seconds and after 1 min, the total drug will be administered at the same rate. An anesthesiologist not involved in the study will record the lowest heart rate during/until 1 min after the initial 0.2 ml/kg of injection as well as during/until 1 min after the total drug administration. This person will be directed to inform the operator in case of any dysrhythmia or significant T-wave changes (increase in amplitude by 25% for 10 seconds compared with baseline) with injection of drug 2 minutes An initial 0.2 ml/kg 0.25% bupivacaine will be injected over 3 to 4 seconds and after 1 min, the total drug will be administered at the same rate. An anesthesiologist not involved in the study will record the lowest heart rate during/until 1 min after the initial 0.2 ml/kg of injection as well as during/until 1 min after the total drug administration. This person will be directed to inform the operator in case of any dysrhythmia or significant T-wave changes (increase in amplitude by 25% for 10 seconds compared with baseline) with injection of drug 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1 .Age between 2years to 8years 2. ASA Physical status 1-2 3. Patients posted for elective infra umbilical surgeries 1 .Parent/guardian refusal 2. History of allergy to either drugs. 3. Infection at the site of injection. 4. coagulopathies or on anticoagulation therapy 5. congenital abnormalities of lower spine and meninges Preschool Child: 2 Year-5 Year 2 Year(s) 8 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 17/02/2022 alexandria ethical committee
Ethics Committee Address
Street address City Postal code Country
17 champollion ElMassala alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To study the effectiveness of perfusion index after caudal block in assessment of onset and adequacy of caudal block in children 10 minutes after intervention
Secondary Outcome To study the effectiveness of changes in heart rate after caudal block in assessment of onset and adequacy of caudal block in children 10 minutes after intervension
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elshatby pediatric hospital Elshatby ALexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principle investigator Moharam beh Alexandria 21547 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yasser Elfeil moharam beh Alexandria 21547 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Yasser Elfeil moharam beh Alexandria 21568 Egypt
Ehsan Deghidy Moharam beh Alexandria 21547 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yasser Elfeil dryasser.elfeil.ye@gmail.com 00201002708808 moharam beh
City Postal code Country Position/Affiliation
alexandria 21547 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries ehsan deghidy drehsan.deghidy@yahoo.com 00201063199658 moharam beh
City Postal code Country Position/Affiliation
alexandria 21547 Egypt lecturer of biomedical informative medical research institute
Role Name Email Phone Street address
Public Enquiries ahmed zarad Ragab88919@gmail.com 00201006824051 54 malak hefny
City Postal code Country Position/Affiliation
alexandria 21523 Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification with Study Protocol, Statistical Analysis Plan, and Informed Consent form will be available for any one for any purpose within one year on my google drive link (dryasser.elfeil.ye@gmail.com) Statistical Analysis Plan,Study Protocol within 1 year all the study data will be available
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