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.: PACTR202006532101847 Date of Approval: 29/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative analgesic efficacy of transversalis fascia plane block in children undergoing lower abdominal surgeries
Official scientific title Perioperative analgesic efficacy of transversalis fascia plane block in children undergoing lower abdominal surgeries
Brief summary describing the background and objectives of the trial Transversalis fascia plane (TFP) block provided effective analgesia with significantly lower perioperative pain scores and opioid consumption for anterior iliac crest bone graft harvesting. It targets the ilio-inguinal and ilio-hypogastric nerves along the posterior third of the iliac crest and proximal to the origin of their lateral cutaneous branches. Aim of the work and hypothesis This prospective, randomized, double blind controlled study is designed to compare the peritoperative analgesic efficacy of USG TFP block with a placebo in children undergoing unilateral inguinal surgeries. We hypothesize that USG TFP block may provide longer and more effective postoperative analgesia when compared with a placebo in pediatric inguinal surgeries.
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: Drugs
Anticipated trial start date 15/06/2020
Actual trial start date 15/06/2020
Anticipated date of last follow up 30/08/2020
Actual Last follow-up date 30/08/2020
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://doi.org/10.4097/kja.20601
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 Control group the patients will receive a placebo in transversalis fascia 0.4mL/kg After induction of anesthesia till 24 hours postoperatively. Fasscia transversalis will be identified by using high frequency ultrasound linear probe after induction of anesthesia. 0.4mL/kg normal saline will be injected into transversalis fascia. 21 Placebo
Experimental Group Transversalis fascia plane block group 0.4mL/kg 0.25% bupivacaine After induction of anesthesia till 24 hours postoperatively. Fasscia transversalis will be identified by using high frequency ultrasound linear probe after induction of anesthesia. 0.4mL/kg normal 0.25% bupivacaine will be injected into transversalis fascia. 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-American Society of Anesthesiologists physical status I–II 2-Aged from 6 months to 5 years 3-Scheduled for elective unilateral inguinal hernia repair 1-History of clinically significant cardiac, hepatic, renal, or neurological dysfunction 2-Coagulopathy 3-Known allergy to amide local anesthetics Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(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 10/06/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total acetaminophen consumption in the first postoperative 12 hours. First postoperative 12 hours.
Secondary Outcome Mean arterial pressure (MAP) and heart rate (HR) will be recorded at 1, 2, 4, 6, 12, 18, 24 hours post-operatively. The behavioral FLACC (Face, Leg, Activity, Cry, Consolability) pain scale will be used for postoperative pain assessment each hour in the first 6 postoperative hours. During surgery and for 24 hours after it
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Mohamed Maher El Morsy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elmorsy dr.sevo.anesthesia@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.4097/kja.20601 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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
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