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.: PACTR202005904505939 Date of Approval: 08/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study between bilateral erector spinae plane and paravertebral blocks for postoperative analgesia after pediatric cardiac surgery
Official scientific title A comparative study between bilateral erector spinae plane and paravertebral blocks for postoperative analgesia after pediatric cardiac surgery
Brief summary describing the background and objectives of the trial The aim of the current study is to test the hypothesis that bilateral thoracic paravertebral block erector spinae block may provide better postoperative analgesia than that of bilateral erector spinae block in pediatric patients submitted for open heart surgery via median sternotomy. This study will be conducted on 80 patients of either sex with their age ranging from 2 to 12 years submitted for on pump elective cardiac surgery. The patients will be randomly assigned into two groups:- Thoracic paravertebral block (PVB) group (n=40): Patients will receive 0.4 ml/kg 0.25% bupivacaine that will be injected into thoracic paravertebral space on each side of the spine. Erector spinae plane block (ESP) group (n=40): Patients will receive 0.4 ml/kg bupivacaine 0.25% that will be injected into erector spinae plane on both sides of the spine. The main collected data will be perioperative opioids requirements, intraoperative hemodynamic stress response, time to extubation and postoperative pain score.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2020
Actual trial start date 01/05/2020
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status 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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Paravertebral 0.4 ml/kg 0.25% bupivacaine 24 hours Patients will receive 0.4 ml/kg 0.25% bupivacaine that will be injected into thoracic paravertebral space on each side of the spine. 40 Active-Treatment of Control Group
Experimental Group Erector spinae 0.4 ml/kg bupivacaine 0.25% 24 hours Erector spinae plane block (ESP) group (n=40): Patients will receive 0.4 ml/kg bupivacaine 0.25% that will be injected into erector spinae plane on both sides of the spine. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study will be conducted on 80 patients of either sex with their age ranging from 2 to 12 years submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, previous back injury or surgery which would preclude the performance of needle puncture, kyphoscoliosis, local infection of the skin and subcutaneous tissue at the site of needle puncture, hypersensitivity to local anesthetics, coagulation disorders, renal, hepatic or pulmonary disease, heart failure and moderate to severe pulmonary hypertension 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 03/05/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 EL Gomhouria st. Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Total dose of intra operative fentanyl requirements. 2- Post operative pain according to objective pain discomfort score(OPDS) in children. 1h, 2h, 6h, 12h, 18, 24 after extubation
Secondary Outcome 1-Heart rate [HR] and invasive mean arterial blood pressure [MAP] will be recorded; before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum. 2- Total dose of intra operative fentanyl requirements (ug/kg). 3- Aortic cross clamping time (minutes). 4- Cardiopulmonary bypass time (minutes). 5-The number of patients who will be extubated in operating room (within 15 minutes of the end of surgery) were recorded. 6- Time to extubation (hours). 7- Post extubation PaO2, PaCO2 will be assessed each 3 hour for 24 hours. 8-Time of first rescue analgesia 9- Total dose of morphine consumption in the first 24 postoperative hours. 10- Intensive care unit (ICU) length of stay. 11- Postoperative complications (the need for re-intubation, nausea and vomiting, pruritus, respiratory depression and neurological deficits) will be reported 1h, 2h, 6h, 12h, 18, 24 after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 EL Gomhouria st. Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 EL Gomhouria st. Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university children hospital MUCH 2 EL Gomhouria st. Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 EL Gomhouria st. Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 EL Gomhouria st. Mansoura 35516 Egypt
Mohamed ahmed maher Ibrahim Elmorsy 2 EL Gomhouria st. Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Elmorsy m.am.elmorsy@gmail.com +201112582480 2 EL Gomhouria st.
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Nabil abd elraouf nabil_abdelraouf@yahoo.com +201001538648 2 EL Gomhouria st.
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
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 EL Gomhouria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper Informed Consent Form,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request ibrahimbaser2010@yahoo.com
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