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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609560494980 Date of Registration: 04/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title using perfusion index to predict success of caudal block in children
Official scientific title perfusion index as a primary predictor of successsful caudal block in inguinal hernia repair in pediatrics
Brief summary describing the background and objectives of the trial caudal block is commonly used for postoperative analgesia in children undergoing inguinal hernia repair.However assesment of block success may be challenging in anesthetized children. perfusion index has been proposed as a non invasive indicator of regional sympathetic blockade. This study aims to evaluate the perfusion index as a primary predictor of successful caudal block in children undergoing elective inguinal hernia repair and to compare it with traditional hemodynamic parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PI CB Peds
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial evaluation, assesment and comparison
Anticipated trial start date 01/06/2026
Actual trial start date 15/03/2026
Anticipated date of last follow up 02/09/2026
Actual Last follow-up date 15/09/2026
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL not yet available
Secondary Ids Issuing authority/Trial register
2 2026 ANET 7 Institutional Review Board, faculty of medicine menoufia university
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 Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anesthesia once before surgery for the whole time of surgery induction of general anesthesia only using sevoflurane inhalation and 1 mic/kg fentanyl and inserting appropriate size laryngeal mask 20 Active-Treatment of Control Group
Experimental Group perfusion index for evaluation of caudal block success in addition to general anesthesia baseline reading then every 20 minutes allover the surgery till the end of surgery monitoring the perfusion index using pulse oximetry fitted to one toe before and after adminstration of caudal block and general anesthesia 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-children aged 1 to 5 years 2-ASA 1 3-scheduled for elective inguinal hernia repair under general anesthesia with planned single shot caudal block for intra/postoperative analgesia 4-parent/gaurdian provides written informed consent 1-known peripheral vascular disease, severe congenital heart disease, or conditions affecting peripheral perfusion (severe dehydration, septic shock) 2-skin lesions, burns or wounds at pulse oximeter site. 3-skin lesions, burns or wounds at the block site 4- preexisting neurologic deficits of lowerlimb 5-allergy to local anesthetics 6-use of vasoactive drugs before or during the measurment period (except if required as rescue) 7- inability to record reliable PI (artifact, movement despite stabilization) Preschool Child: 2 Year-5 Year 1 Year(s) 5 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 10/02/2026 Faculty of medicine menoufia university
Ethics Committee Address
Street address City Postal code Country
yassin abdelghaffar street shebin alkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to asses the efficacy of the perfusion index PI as a primary indicator for predicting a successful caudal block at baseline post induction, 3,5,10,15,20 minutes after block and every 20 minutes till the end of surgery also at atime of skin incision
Secondary Outcome to compare PI to mean arterial pressure, sphincter tone, cremastric reflex, total intraoperative anesthetic and analgesic consumption in detecting the success of the block at baseline post induction, 3,5,10,15,20 minutes after block and every 20 minutes till the end of surgery also at atime of skin incision
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufia university hospital theatres yassin abdelghaffar street, off gamal abdel nasser street, beside national liver institute shebin Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufia university hospitals not applicable not applicable Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine menoufia university yassin abdelghaffar street shebin alkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed gaafar mo7amedgaafar@gmail.com 01064530994 ahmed hanbal street
City Postal code Country Position/Affiliation
shebin alkom 32511 Egypt anesthesia resident in menoufia university hospitals
Role Name Email Phone Street address
Public Enquiries mohamed gaafar mo7amedgaafar@gmail.com 01064530994 ahmed hanbal street
City Postal code Country Position/Affiliation
shebin alkom 32511 Egypt anesthesia resident in menoufia university hospitals
Role Name Email Phone Street address
Scientific Enquiries mohamed gaafar mo7amedgaafar@gmail.com 01064530994 ahmed hanbal street
City Postal code Country Position/Affiliation
shebin alkom 32511 Egypt anesthesia resident in menoufia university hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes i intend to share my raw data, stydy findings and summary results that is de-identified with researchers or other organisations or scientific meetings upon completion of the study Informed Consent Form after publication on reasonable request data will be granted to researchers with a valid scientific proposal and approval from an institutional ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 11/06/2026 as requested by the trial reviewer to evaluate the perfusion index as a primary predictor of successful caudal block in children undergoing elective inguinal hernia repair and to compare it with traditional hemodynamic parameters. caudal block is commonly used for postoperative analgesia in children undergoing inguinal hernia repair.However assesment of block success may be challenging in anesthetized children. perfusion index has been proposed as a non invasive indicator of regional sympathetic blockade. This study aims to evaluate the perfusion index as a primary predictor of successful caudal block in children undergoing elective inguinal hernia repair and to compare it with traditional hemodynamic parameters.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 11/06/2026 as requested by the trial reviewer TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, Hendokasha93@gmail.com, 41243_38473_4737.pdf TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, Hendokasha93@gmail.com, 41243_38473_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/08/2026 as requested by the trial reviewer TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, Hendokasha93@gmail.com, 41243_38473_4737.pdf TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, Hendokasha93@gmail.com, 41243_38473_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/08/2026 as requested by the trial reviewer TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, Hendokasha93@gmail.com, 41243_38473_4737.pdf TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, mo7amedgaafar@gmail.com, 41243_38473_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 26/08/2026 as requested by the trial reviewer TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, mo7amedgaafar@gmail.com, 41243_38473_4737.pdf TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, medcine@menofia.edu.eg, 41243_38473_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 26/08/2026 as requested by the trial reviewer TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, mo7amedgaafar@gmail.com, 41243_38473_4737.pdf TRUE, Faculty of medicine menoufia university, yassin abdelghaffar street, shebin alkom, 32511, Egypt, , 10 Feb 2026, 01220593448, medcine@menofia.edu.eg, 41243_38473_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 11/06/2026 as requested by the trial reviewer self funded, not applicable, not applicable, , Egypt, Self Funded, menoufia university hospitals, not applicable, not applicable, , Egypt, University,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 11/06/2026 as requested by the trial reviewer available on reasonable request i intend to share my raw data, stydy findings and summary results that is de-identified with researchers or other organisations or scientific meetings upon completion of the study