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.: PACTR202010495971273 Date of Approval: 09/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Posterior versus Anterior Approach in Pediatrics undergoing Laparoscopic Inguinal Hernia Repair
Official scientific title Ultrasound Guided Quadratus Lumborum Block: Posterior versus Anterior Approach in Pediatrics undergoing Laparoscopic Inguinal Hernia Repair
Brief summary describing the background and objectives of the trial Quadratus Lumborum Block (QLB) is one of trunk block that has been used in last years. It is described as the administration of local anesthetic between the quadratus muscle and the medial layer of the thoracolumbar fascia by ultrasound-guidance. It has been reported that a wider sensorial block area can be obtained from the single injection of QLB when performed during upper and lower abdominal 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: Other
Anticipated trial start date 28/10/2020
Actual trial start date
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group posterior approach quadratus lumborum block 0.3ml/kg of local anesthetic once The patient will be placed in a lateral decubitus position. A linear ultrasound probe (6-12 MHz) will be placed on the iliac crest and in the transverse position to the posterior axillary line. After abdominal wall muscles will be identified as three layers the probe directed posteriorly and the fascia transversalis (TF), thoracolumbar fascia and Quadratus lumborum (QL) muscles were visualized. needle inserted with the in-plane technique between the middle layer of the thoracolumbar fascia and QL muscle at the posterior edge of the quadratus lumborum muscle. After confirming the site by hydro dissection, bupivacaine 0.25% is injected 0.3ml/kg on each side 30 Active-Treatment of Control Group
Experimental Group Anterior approach quadratus lumborum block 0.3ml/kg of local anesthetic on each side. once The patient will be placed in a lateral decubitus position. A linear ultrasound probe (6-12 MHz) will be placed on the iliac crest and in the transverse position to the posterior axillary line. Subsequently, the L4 vertebral body at the L4 vertebra level, along with the L4 transverse process, the QL, the erector spinae, and the psoas muscle, will be identified as the Shamrock sign. needle is directed towards the thoracolumbar fascia from the posterior aspect of the transducer to the posteromedial anterolateral direction between the psoas muscle and the QL muscle, anterior to the QL muscle. After confirming the site by hydro dissection, bupivacaine 0.25% is injected 0.3ml/kg on each side. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients aged 1 to 6 years American Society of Anesthesiologists (ASA) physical status of I or II Patients with known allergies to local anesthetics infection of injection sites coagulation disorders Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 6 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 01/09/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative analgesic requirement once with in 24 hour
Secondary Outcome duration of analgesia once with in 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University EL Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad El Geish Tanta 31527 Egypt
Dina Ahmed Ali El Malla El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries Dina El Malla dr_dina90@yahoo.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Scientific Enquiries Mona El Mourad monamorad80@gmail.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia and Surgical Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1-Demographic data 2-total postoperative analgesic requirement in 24 hours 3- Duration of analgesia Study Protocol 2 years to those who request the data via the email of the principal investigator according to the cause of request
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