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.: PACTR202203906027106 Date of Approval: 23/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title QLB Vs Epidural in pediatrics
Official scientific title Can ultrasound guided quadratus lumborum block achieve comparable analgesic effect to epidural block in pediatric abdominal surgery ?
Brief summary describing the background and objectives of the trial Aim of study is to compares the quality of pain relief in pediatric patient undergoing abdominal surgery. The primary outcome is to assess the total analgesia consumption after Quadratus Lumborum Block (QL) and epidural anaesthesia in children undergoing abdominal surgery .The secondry outcomes are assesment of postoperative analgesic effect by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) , Time of first analgesic request ,intraoperative heamodynamics (BP,HR) and occurance of complications as Nausea & Vomiting . ry receiving either QL block or EB .
Type of trial RCT
Acronym (If the trial has an acronym then please provide) QLB vs Epidural in pediatrics
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 07/11/2020
Actual trial start date 08/11/2020
Anticipated date of last follow up 07/07/2021
Actual Last follow-up date 27/05/2021
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 58
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group QLB 24 h U/S guided QLB 29 Placebo
Experimental Group Epidural block 24 h Epidural block 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for abdominal surgery . - Age Group: ( 2-7 years ) - either sex - American Society Anesthesiologists (ASA) physical status I to II. -Allergy to one of the agents used. - With preexisting cardiac dysfunction -Severe or uncontrolled renal, hepatic or endocrinal diseases. -parents refusal of consent . Preschool Child: 2 Year-5 Year 2 Year(s) 7 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 26/06/2020 I. R. B
Ethics Committee Address
Street address City Postal code Country
I. R. B office. Building A. Ground floor. Faculty of Medicine. Mansoura university Mansoura 55555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome .The secondry outcomes are assesment of postoperative analgesic effect by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) , Time of first analgesic request ,intraoperative heamodynamics (BP,HR) and occurance of complications as Nausea & Vomiting . 24 hours
Primary Outcome Study outcome The primary outcome is to assess the total analgesia consumption after Quadratus Lumborum Block (QL) and epidural anaesthesia in children undergoing abdominal surgery. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital Al gomhouria Mansoura 55555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Al gomhouria Mansoura 55555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Algomhuria Mansoura 55555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Hazem Elsayed Moawad Al gomhouria Mansoura 55555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Alseoudy Drs3ody.mansora@mans.edu.eg +201006224551 Abdelsalam Aref
City Postal code Country Position/Affiliation
Mansoura 55555 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mohamed Wageh Mohamedwageh22@yahoo.com 001093345848 Ahmed Maher
City Postal code Country Position/Affiliation
Mansoura 55555 Egypt Resident
Role Name Email Phone Street address
Scientific Enquiries Hazem Moawad Hazemmoawad@yahoo.com 001121516041 Gehan
City Postal code Country Position/Affiliation
Mansoura 55555 Egypt Ass. Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of IPD collected during the trial will be available after de-identification. Study potocol, statistical analysis plan and informed consent form also will be available beginning 3 months and ending 5 years following article publication. With Investigators whose proposed use of data has been approved by independant review Committee for IPD meta-analysis. Mechanism by which data will be available is not applicable. Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months Children aged 2 to 7 years undergoing abdominal surgery
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/02/2022 Result - 17/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information