Analgesic Efficacy of Bilateral US Guided TTPB vs ESPB in Pediatric Patients Undergoing Corrective Cardiac Surgeries

NCT05559684 | Completed DMC

• 1 other identifier: md-61-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Corrective cardiac surgeries include a bundle of major surgeries that take place in pediatric patients and require imperative perioperative pain control; hence, the art of healing starts from trying to diminish or abolish pain. The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years . In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response; however, large doses can cause over sedation, respiratory depression and prolonged mechanical ventilation after surgery . There are many ways to limit pain in such population with the topper potent opioids in the last several years. But new regional pain management modalities started to arise because of their known effect to diminish neuroendocrine stress response, provide excellent postoperative analgesia, and facilitate early postoperative extubation . Of the new evolving methods, the bilateral Transversus Thoracic Muscle Plane Block (TTPB) provides analgesia to the anterior chest wall and proved to be efficient in pediatric patients undergoing cardiac surgery using a median sternotomy approach . The bilateral Erector Spinae Plane Block (ESPB) is also one of the recently known pain controlling techniques used in pediatric cardiac surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block .

Conditions

Pain, Postoperative

Keywords

Transversus thoracic muscle plane block; Erector spinea plane block; Pediatric cardiac surgery; Multimodal anelgesia in pediatric cardiac surgeries; TTPB; ESPB

Outcome Measures

Primary Outcomes (1)

• The total dose of intraoperative fentanyl

  Amount of fentanyl required by patients in each group

  All through the surgery

Secondary Outcomes (6)

• Pain assessment

  Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively

• Intra and postoperative haemodynamics including HR and MBP

  Intraoperative T1: baseline reading 5 min after intubation, T2: after skin incision, T3: after sternotomy, T4: after aortic cannulation, T5: after weaning from bypass and T6: after skin closure then Immediately after admission to ICU, 1,2,4,8,12 hours

• Total consumption of Fentanyl during the 1st 12 hours post operatively

  Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively

• Time (in minutes) to 1st rescue analgesia (Fentanyl) post operatively

  First 12 hours postoperatively

• Time of extubation

  First 12 hours postoperatively

Study Arms (3)

Control

NO INTERVENTION

Patients in this group will receive fentanyl infusion at a dose of (0.5 μg/kg/h) all through the whole operation; in addition to 1μg/kg during skin incision, sternotomy, aortic cannulation and increase in MBP or HR more than 20% of the baseline readings.

Erector Spinae Plane Block

ACTIVE COMPARATOR

This group will receive fentanyl infusion at a dose of (0.5 μg/kg / h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side

Procedure: Erector spinae plane block

Transversus Thoracis Plane Block

EXPERIMENTAL

This group will receive fentanyl infusion at a dose of (0.5 μg/kg / h) all through the whole operation plus ultrasound guided bilateral TTPB which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side

Procedure: Transversus thoracis plane block

Interventions

Erector spinae plane block PROCEDURE

Under strict aseptic precautions, The T3 spinous process will be located. A high-frequency 12 MHz linear US transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process. Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle. Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process.

Erector Spinae Plane Block

Transversus thoracis plane block PROCEDURE

Under strict aseptic precautions, the T4-T5 intercostal space is identified under US using the US probe in the longitudinal plane 1 cm lateral to the sternal border. A high-frequency linear transducer is used. Next, a parasternal sagittal view of the intercostal muscle and the transverses thoracis muscle between the 4th and 5th rib is visualized above the pleura and a 22G, 5-10 cm needle is inserted in-plane (according to patient's body habitus and relevant anatomy) to the transducer with bevel up until the tip of the needle is located in the transverses thoracis muscles. After excluding intravascular and intrapleural placement, local anesthetic is adminstred bilaterally by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side.

Transversus Thoracis Plane Block

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 2 months - 4 years.
• ASA II and III.
• Patients undergoing corrective cardiac surgeries with midline sternotomy incision.

You may not qualify if:

• Patients whose parents or legal guardians refusing to participate.
• Preoperative mechanical ventilation.
• Preoperative inotropic drug infusion.
• Known or suspected coagulopathy.
• Known or suspected allergy to any of the studied drugs.
• Severe pulmonary hypertension.
• Cardiopulmonary bypass time more than 90 minutes.
• Aortic cross-clamp time more than 45 minutes.
• Total time from induction till ICU transfer more than 4 hours and 30 mins.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abu Elrish hospitals

Cairo, Egypt

Location

Related Publications (1)

• Madkour MAFA, Abueldahab EIB, Elela AHA, Youssef MF, Gado AA. Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2025 Jun;39(6):1495-1505. doi: 10.1053/j.jvca.2025.03.001. Epub 2025 Mar 3.

  PMID: 40122711 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Amel H Abo Elela, Professor

  Cairo University

  STUDY CHAIR

• Mohamed F Youssef, Professor

  Cairo University

  STUDY DIRECTOR

• Mai A Madkour, Professor

  Cairo University

  STUDY DIRECTOR

• Ahmed A Gado, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical doctor not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESPB in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesist blinded to the type of block will be responsible for patient management and collecting the intra-operative and postoperative data
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 1, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: November 2022 - November 2023
• Access Criteria: URL

Locations

EG (1)