Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy

NCT ID: NCT06873906

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-04-01

Brief Summary

In this study we are aiming to compare the Erector Spinae Plane Block and the Deep Parasternal intercostal plane block as regard to their technique, application and outcome in order to describe the most suitable method for pediatric cardiac patients undergoing primary repair of septal defects

The primary outcome of this study will be the time of the first request for postoperative analgesics by FLACC pain scale more than 4 The secondary outcomes will be the total postoperative analgesic consumption, time for extubation, the incidence of nausea and vomiting, hemodynamic instability, onset of ambulation and any other complications on the first day after surgery

Participants will be enrolled in this double-blinded randomly allocated using computer-based randomization into three groups. Group 1 will receive bilateral deep parasternal intercostal plane block. Group 2 will receive bilateral erector spinae plane block. Group 3 will receive conventional analgesic regimen without having a regional block

Detailed Description

Pediatric cardiac surgery involving median sternotomy can be associated with significant postoperative pain. Poorly controlled pain following cardiac surgery has been shown to be a risk factor for increased morbidity, including severe cardiopulmonary dysfunction, hypercoagulability, and immunosuppression.

Post-operative pain management, which provides effective analgesia, minimizes side effects and contributes to enhanced recovery after surgery, is a unique challenge in the pediatric cardiac surgery population. The ideal post-operative analgesic regimen would enable early separation from mechanical ventilation, decrease opioid consumption, and expedite discharge from the intensive care unit.

Systemic opioids and non-steroidal anti-inflammatory drugs have been the mainstay for treating pain during the perioperative period in children undergoing median sternotomy for cardiac surgery. The traditional high-dose opioid approach is associated with a decreased stress response but at the expense of prolonged mechanical ventilation, and increased opioid-related side effects. NSAIDs are effective as part of a multimodal analgesic approach, but their use can be limited due to concerns regarding coagulopathy or impairment of renal function.

Regional anesthesia is becoming increasingly popular in pediatric cardiac surgery for its opioid sparing effects. By blocking the afferent impulses from surgical sites, the need for supplemental opioids is reduced. Neuraxial catheters, while effective, are often not utilized in the setting of full heparinization and coagulopathy due to the small yet significant risk of epidural hematoma formation. Paravertebral blocks have similar risk and side effect profiles to neuraxial catheters and require blocks to be performed bilaterally with a posterior approach. Truncal blocks such as erector spinae plane blocks, as well as superficial and deep parasternal blocks, have been shown to provide adequate pain relief for cardiac surgery, and have been gaining popularity.

Appropriate pain relief from a sternotomy incision can be achieved by blocking the second to sixth thoracic intercostal nerves. The newer ultrasound-guided deep parasternal block (previously known as transversus thoracic muscle plane block, involves deposition of a local anesthetic between the internal intercostal and transversus thoracic muscles and effectively blocks the anterior branches of intercostal nerves T2-6.

The recent American Association for Thoracic Surgery Congenital Cardiac Surgery Working Group 2021 consensus document on enhanced recovery after pediatric cardiac surgery gives mention to bilateral transversus thoracic muscle plane blocks (now deep parasternal block) as a regional anesthetic option with opioid-sparing effects but states that more data are needed to determine their efficacy.

On the other hand, Erector spinae plane block is an ultrasound- guided interfascial plane block that has been proposed for the management of thoracic pain. When applied bilaterally, ESPB has been demonstrated to provide effective analgesia at the selected dermatomes including the upper chest (T2-T4) and the mid-chest (T5-T7), which might be useful for postoperative analgesia after cardiac surgery.

In this study, we will compare the use of bilateral single injection deep parasternal blocks versus a second group receiving bilateral single injection erector spinae blocks in pediatric patients undergoing median sternotomy for cardiac surgery.

Conditions

Septal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Deep Parasternal Intercostal Plane Block

Patients will receive bilateral deep parasternal intercostal plane block.

Group Type: ACTIVE_COMPARATOR

Deep Parasternal intercostal plane block

Intervention Type: PROCEDURE

Patients will receive bilateral deep parasternal plane block using, 1mg/kg of 0.25% bupivacaine on each side under ultrasound guidance. The total dose of bupivacaine amounting to 2 mg/kg.

Erector Spinae plane block

Patients will receive bilateral erector spinae plane block

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: PROCEDURE

Patients will receive bilateral erector spinae plane block using, 1 mg/kg of 0.25% bupivacaine will be administered on each side under ultrasound guidance. The total dose of bupivacaine amounted to 2 mg/kg

conventional analgesic regimen

patients will receive conventional analgesic regimen

Group Type: ACTIVE_COMPARATOR

conventional analgesic regimen

Intervention Type: DRUG

Anesthesia will be induced with IV ketamine, 2 mg/kg, fentanyl, 2 µg/kg, and rocuronium 0.9 mg/kg, administered to facilitate endotracheal intubation.

Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental dosage, and intravenous rocuronium 0.15 mg/kg administration according to nerve stimulator.

Interventions

Deep Parasternal intercostal plane block

Patients will receive bilateral deep parasternal plane block using, 1mg/kg of 0.25% bupivacaine on each side under ultrasound guidance. The total dose of bupivacaine amounting to 2 mg/kg.

Intervention Type: PROCEDURE

Erector Spinae Plane Block

Patients will receive bilateral erector spinae plane block using, 1 mg/kg of 0.25% bupivacaine will be administered on each side under ultrasound guidance. The total dose of bupivacaine amounted to 2 mg/kg

Intervention Type: PROCEDURE

conventional analgesic regimen

Anesthesia will be induced with IV ketamine, 2 mg/kg, fentanyl, 2 µg/kg, and rocuronium 0.9 mg/kg, administered to facilitate endotracheal intubation.

Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental dosage, and intravenous rocuronium 0.15 mg/kg administration according to nerve stimulator.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pediatric patients with acyanotic heart disease
• Patients with septal defect undergoing primary repair
• ASA Ⅰ and Ⅱ

Exclusion Criteria

• Patient's guardian refusal of procedure or participation in the study.
• Patients with hemodynamic instability
• Preexisting infection at the block site
• Allergy to local anesthetics
• Psychiatric illness
• Abnormal coagulation profile
• Preoperative ejection fraction less than 35%
• Recurrent ventricular arrhythmias
• Emergency Surgery
• Redo surgeries

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Ahmed Hanee Abdelmohaimen Bakr

Assisstant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Sarah A. H. Bakr, Ms degree of Anesthesia

Role: CONTACT

sarahhanee@med.asu.edu.eg

[202] 01062638487

Amin M Alansary, MD of Anesthesia

Role: CONTACT

aminalansary@yahoo.com

[202] 01007962192

Other Identifiers

FMASU MD124/2024

Identifier Type: -

Identifier Source: org_study_id