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.: PACTR202202799603736 Date of Approval: 16/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic efficacy of ultrasound-guided mid-point transverse process to pleura block in pediatric patients undergoing open cardiac surgery: a randomized controlled study
Official scientific title Analgesic efficacy of ultrasound-guided mid-point transverse process to pleura block in pediatric patients undergoing open cardiac surgery: a randomized controlled study
Brief summary describing the background and objectives of the trial Our hypothesis is that ultrasound-guided MTPB will be effective in providing postoperative analgesia in terms of opioid consumption and pain severity after pediatric open cardiac surgery. The aim of the study The aim of the study is to compare between patients who will receive a single shot ultrasound-guided bilateral MTPB and patients who will receive only intravenous analgesics regarding: - 1- The 24 h postoperative opioid analgesic requirements. 2- Time to first rescue analgesia. 3 - The 24 h postoperative pain score. 4- 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,Cardiology,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/02/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
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
Control Group no block iv opioid only intra and post operative opioid only 26 Active-Treatment of Control Group
Experimental Group Ultrasound guided Midpoint transverse process to pleura block bupivacaine 0.3ml/kg on each side After induction After the induction of anesthesia, the patient will be placed in a lateral position to perform the block on both sides. The spinous process of the fourth and fifth thoracic vertebrae will be identified and marked. The ultrasound-guided MTPB will be done under complete sterilization by using Sterillium®, sterile drapes, and putting the ultrasound probe in a sterile sheath. Ultrasound high frequency linear transducer of a GE Vivid S5 ultrasonography (General Electric Ving Med Systems, Horten, Norway) 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 (stimuplex®; B. Braun Medical, Bethlehem, Pa) will inserted in an in-plane technique and will be advanced till its tip become just above superior costotransverse ligament midway between the transverse process of T4 and T5 and then we will inject 0.25% bupivacaine 0.3ml/kg on each side. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Children aged between 2 to 12 years 2- American Society of Anesthesiologists physical status Ⅰ& Ⅱ 3- Elective open cardiac surgery via median sternotomy 1- Repeated cardiac surgery 2- Emergency surgery 3- Intubated patients 4- Bleeding disorders Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 10 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 03/02/2022 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 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. postoperative 24 hours
Secondary Outcome 1- Postoperative pain score at rest, that was assessed by modified objective pain discomfort score (MOPDS).in children at 1, 2, 6, 12, 18 and 24 hours after extubation. Fentanyl 1μg/kg will be given as a rescue analgesic when MOPS greater than 3 at rest. 2- Heart rate (HR) and mean arterial pressure (MAP) before and after induction of anesthesia, after skin incision, after sternotomy, 15 minutes after CPB and after the closure of sternum. 3- Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery. 4- Aortic cross clamping time (min) starting from the application of the clamp to aorta till its removal after completing the surgical repair. 5- CPB time and duration of surgery. 6- Time to first rescue analgesia. 7- Intensive care unit (ICU) length of stay. Intraoperative and 24h postoperative
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
Ibrahim Abdelbaser 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 Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia faculty of medicine Mansoura university Egypt.
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabil_abdelraouf@yahoo.com +201001536848 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anaesthesia faculty of medicine Mansoura university Egypt
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia faculty of medicine Mansoura university Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate 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