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NCT Number: NCT06873906

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

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

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Parasternal Intercostal Plane Block

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

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

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.

Primary outcomes

  1. Time of the first request for postoperative analgesics

    Time frame: 24 hours

    The time of the first request for postoperative analgesics by Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale more than 4.

    Patients will be assessed at 0, ½, 1, 2, 4, 6, 8, 12, 24 hours.

Secondary outcomes

  1. Total postoperative analgesic consumption.

    Time frame: 24 hours

    Comparison between the three groups considering the amount of opioids consumed according to FLACC scale in the post operative period.

  2. Time for extubation

    Time frame: 24 hours

    Comparison between the three groups considering the effect of different pain control modalities on aiding fast track extubation.

  3. Incidence of nausea

    Time frame: 24 hours

    Comparison between the three groups considering the effect of different pain control modalities on the incidence of nausea and vomiting, either by a direct central effect or indirectly due to pain.

  4. Hemodynamic instability

    Time frame: 24 hours

    Comparison between the three groups considering the incidence of hemodynamic instability due to the effect of local anesthetics on hemodynamics or the depressor effect of opioids on the first hours after surgery. Also, the surgical causes of hemodynamic instability in the first day and its effect on the study.

  5. Onset of ambulation

    Time frame: 24 hours

    Comparison between the three groups regarding the onset of ambulation and the effect of the efficacy of pain control in light of early recovery after surgery.

  6. incidence of vomiting

    Time frame: 24 hours

    Comparison between the three groups considering the effect of different pain control modalities on the incidence of nausea and vomiting, either by a direct central effect or indirectly due to pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Amin M Alansary, MD of Anesthesia

CONTACT

[email protected]

[202] 01007962192

Sarah A. H. Bakr, Ms degree of Anesthesia

CONTACT

[email protected]

[202] 01062638487

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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