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.: PACTR202207485098938 Date of Approval: 08/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-guided thoracic retrolaminar block versus erector spinae plane block on opioid consumption after pediatric open-heart surgery
Official scientific title The effect of ultrasound-guided thoracic retrolaminar block versus erector spinae plane block on opioid consumption after pediatric open-heart surgery: a randomized controlled non-inferiority study
Brief summary describing the background and objectives of the trial ultrasound-guided bilateral thoracic retrolaminar block (TRLB) will be non-inferior to erector spinae plane block (ESPB) in providing postoperative analgesia in terms of opioid consumption and pain severity after pediatric open cardiac surgery. The aim of the study is to compare between a single shot ultrasound-guided bilateral thoracic retrolaminar block and erector spinae plane block regarding: 1. The 24-hour postoperative opioid analgesic requirements. 2. Time to first rescue analgesia. 3. The 24-hour postoperative pain score. 4. The incidence of block-related complications. 5. Time to extubation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial postoperative analgesia and fascial plane blocks
Anticipated trial start date 01/07/2022
Actual trial start date 08/07/2022
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group thoracic retrolaminar block TRLB Group2 0.4 mL/kg 0.25% bupivacaine on each side After induction of general anesthesia one shot injection using ultrasound high frequency linear transducer of a GE Vivid S5 ultrasonography will be placed in a parasagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the muscles (trapezius, rhomboid major, erector spinae and paraspinal muscles) and vertebral lamina. A 50 mm 22-gauge sonographic needle will inserted in an in-plane technique from a cephalad to a caudal direction and will be advanced till touching the lamina of the fourth thoracic vertebra then the injectate will be given and that on each side 25
Control Group Erector spinae plane block ESPB group 1 0.4 mL/kg 0.25% bupivacaine on each side one shot one shot injection on each side after induction of general anesthesia Ultrasound high frequency linear transducer of a GE Vivid S5 ultrasonography will be placed in a parasagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the muscles (trapezius, rhomboid major, erector spinae and paraspinal muscles) and vertebral lamina. A 50 mm 22-gauge sonographic needle will be inserted in an in-plane technique from a cephalad to a caudal direction and sonographic needle touches the transverse process of the fourth thoracic vertebra and the injectate will be given and that will be done on both sides 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children aged between 2 to 12 years. 2. Elective open cardiac surgery via median sternotomy for the repair of simple congenital heart diseases. 3. ASA I:III 1. Repeated cardiac surgery. 2. Emergency surgery. 3. Intubated patients. 4. Patients receiving inotropic support. 5. Presence of pulmonary hypertension. 6. Presence of bleeding disorders. 7. Presence of allergy to the amide local anesthetics. 8. Presence of thoracic spine deformity and history of thoracic vertebrae trauma or surgery. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 12 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 03/03/2022 IRB institutional review board
Ethics Committee Address
Street address City Postal code Country
mansoura faculty of medicine, Elgomhoria street Mansoura 22011820 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose of fentanyl consumption in the first postoperative 24 hours in the first postoperative 24 hours
Secondary Outcome Postoperative pain score at rest, that was assessed by modified objective pain discomfort score (MOPDS) in children pain score at 1, 2, 6, 12, 18 and 24 hours after extubation.
Secondary Outcome Total intraoperative fentanyl requirements. Time to first rescue analgesia. Intensive care unit (ICU) length of stay. The incidence of postoperative complications (pruritus, nausea and vomiting, pneumothorax, hematoma or local anesthetic toxicity) in postoperative 24hours
Secondary Outcome Aortic cross clamping time. Cardiopulmonary bypass (CPB) time and duration of surgery intraoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Children Hospital Mansoura city. Elgomhoria street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoria street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura faculty of medicine Elgomhoria street Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdellatif Elsayed justatayef@gmail.com 00201065401438 mansoura. elgomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt Ahmed A.Elsayed
Role Name Email Phone Street address
Public Enquiries Rania Elmohamady Elbadrawy raniaelmohamady@gmail.com 00201128819560 Mansoura university hospitals , elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Rania E. Elbadrawy
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Ibrahim Abdelbaser ibraheem2005@mans.edu.eg 02001004976825 Mansoura pediatric hospital. Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Ibrahim I. Abdelbaser
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes any researcher covered by ethical committee or institutional review board after request from main author Study Protocol 2 years controlled any researcher covered by ethical committee or institutional review boar dafter request from main author
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