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.: PACTR201910859535009 Date of Approval: 16/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery
Official scientific title Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a prospective randomized study
Brief summary describing the background and objectives of the trial Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site. Pain after cardiac surgery is most severe during the first day and then decreases in intensity over the next few days. Systemic opioids have been the mainstay for managing pain during the perioperative period in children undergoing median sternotomy for cardiac surgery. In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25‐50 µg/kg. Today lower doses are often used in order to achieve early extubation. At such doses, there is no guarantee that the stress response is completely abolished. One way to overcome this problem is the use of local anesthetic techniques. These techniques can block afferent impulses from corresponding nerves and thereby either reduce the need for opioids or eliminate them completely . Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children. Central neuraxial blockade including spinal have been used but have not gained wide spread acceptance, due to the fear of potential associated complications in heparinized patients, especially epidural hematoma. However recent advances, in particular use of bedside ultrasound, allow blockade of peripheral nerves closer to the site of surgery and without instrumentation inside the spinal canal. Its better to use superficial blocks, if they provide adequate pain relief. To provide appropriate pain relief from a sternotomy incision, it is essential to block the second to sixth thoracic intercostal nerves that innervate the sternum and parietal pleura as well as pain afferents from the pericardium which is transmitted via the vagus, phrenic, and sympathetic chain. The transversus thoracis muscle plane (TTP) block is a newly-developed, single-shot nerve block technique that deposits local anesthetic in the transversus thoracis muscle plane between the internal intercostal and transversus thoracis muscles to provide perioperative analgesia for surgeries involving the anterior chest wall.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial to evaluate the efficacy of bilateral transversus thoracis muscle plane block in pediatric cardiac surgery, so the aim of the current study is to test the hypothesis that bilateral transversus thoracis muscle plane block may facilitate early extubation and reduce perioperative opioids requirements in pediatric patients submitted for open heart surgery via median sternotomy.
Anticipated trial start date 01/11/2019
Actual trial start date 01/11/2019
Anticipated date of last follow up 15/10/2020
Actual Last follow-up date 01/09/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL https://doi.org/10.1016/j.jclinane.2020.110002
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline that will be injected into transversus thoracis muscle plane Patients will receive 0.4 ml/kg normal saline that will be injected into transversus thoracis muscle plan between the internal intercostal and transversus thoracis muscles on each side of sternum. After induction of anesthesia Patients will receive 0.4 ml/kg normal saline that will be injected into transversus thoracis muscle plan between the internal intercostal and transversus thoracis muscles on each side of sternum. 40 Placebo
Experimental Group transversus thoracis muscle plane block 0.4 ml/kg bupivacaine 0.25% that will be injected into transversus thoracis muscle plane after induction of anesthesia Patients will be premedicated with intramuscular 0.1 mg/Kg midazolam and 0.015mg/kg atropine sulphate 15 minutes before induction of general anesthesia. Arterial catheter will be inserted into femoral artery under local anesthesia with complete aseptic condition, 5 lead electrocardiograph and pulse oximetry will be attached to the patient. Anesthesia will be induced with sevoflurane, fentanyl (3μg/kg i.v) and rocuronium (0.9 mg/kg I.V) will be used to facilitate tracheal intubation. After induction of anesthesia, a central venous catheter will be inserted into right internal jugular vein. Anesthesia will be maintained with sevoflurane (1-3)% inspired in combination with oxygen 50% in air and rocuronium (0.3 mg/kg/hour) and fentanyl (1μg/kg/hour). Incremental doses of fentanyl (3-5) μg/kg will be given if systolic arterial blood pressure and/or heart rate increased by more than 20% above baseline. Neuromuscular blockade will be reversed at the end of surgery if the patient will valuable for extubation by 0.02mg/kg atropine and 0.04mg/kg prostigmine. Transversus thoracis muscle plane (TTP) block technique The technique of TTP block was described by Ueshima (Ueshima H 2018). The TTP block will be performed bilaterally in a supine position after induction of anesthesia after complete aseptic precautions using a high frequency linear ultrasound probe. The anterior chest wall and ultrasound probe will be sterilized with sterillium with isolation the area around the sternum with sterile drapes. The probe of the ultrasound will be placed at sagittal plane 1 cm lateral to the sternum to count the costal cartilage of the ribs from the second rib near the clavicle to the fifth rib. Then the linear probe will be rotated by 90° and placed between the forth and the fifth costal cartilages connecting at the sternum near nipple. Then, the transversus thoracis muscle and the internal intercostal muscle will be identified. The local anesthetic will be injected into the interfascial plane between the transversus thoracic muscle and the internal intercostal muscle between the fourth and fifth costal cartilages connecting at the sternum. The dose of local anesthetic for TTP block in pediatric is not described before. Transversus thoracis muscle plane block is equivalent to transverse abdominis plane (TAP) block, so we will use the same dose of bupivacaine of TAP block in children which is 0.4 mL/kg of 0.25% bupivacaine on each side of the sternum for the TTP block (Karnik PP et al 2019 ). 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 2 to 12 years. 2. Scheduled for elective cardiac surgery. 3. Via median sternotomy. 4. Congenital simple left to right intra cardiac shunt 1. Refusal patients guardians. 2. Redo cardiac surgery. 3. Local infection of the skin and subcutaneous tissue at the site of needle puncture 4. Hypersensitivity to local anesthetics. 5. Coagulation disorders. 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 12/10/2019 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 1- Total dose of intra operative fentanyl requirements. 2- Post operative pain that will be assessed at 1h, 2h, 6h, 12h, 18, 24 after extubation, and will be managed according to objective pain discomfort score(OPDS) in children. Intra operative fentanyl requirements. Post operative pains score
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 intraoperative and 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
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
Nabil Abd El raouf Abd El mageed 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 Abd Elraouf nabil_abdelraouf@yahoo.com +20100491538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care
Role Name Email Phone Street address
Scientific Enquiries Hani Taman hani_taman@yahoo.com +201008288242 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical intensive care
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 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
PubMed indexed journal 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