Septal DefectPhase 3NCT06873906
Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy
A Phase 3 study testing Deep Parasternal intercostal plane block, Erector Spinae Plane Block and conventional analgesic regimen in people with Septal Defect, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Septal Defect
- What is being tested?
- Deep Parasternal intercostal plane block, Erector Spinae Plane Block and conventional analgesic regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 1 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with acyanotic heart disease
- Patients with septal defect undergoing primary repair
- ASA Ⅰ and Ⅱ
Who cannot join
- 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
Show all 10Show fewer
- Preoperative ejection fraction less than 35%
- Recurrent ventricular arrhythmias
- Emergency Surgery
- Redo surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
Read the 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
- Being tested
- Deep Parasternal intercostal plane block, Erector Spinae Plane Block, conventional analgesic regimen
- Keywords
- septal defect, acyanotic heart disease, median sternotomy, deep parasternal intercostal plane block, erector spinae plane block, eras
- Medical subject headings
- Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Parasternal intercostal plane blockProcedure or surgery
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 BlockProcedure or surgery
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 regimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Parasternal Intercostal Plane Block | Active comparator | Patients will receive bilateral deep parasternal intercostal plane block. Receives: Procedure: Deep Parasternal intercostal plane block |
| Erector Spinae plane block | Active comparator | Patients will receive bilateral erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
| conventional analgesic regimen | Active comparator | patients will receive conventional analgesic regimen Receives: Drug: conventional analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of the first request for postoperative analgesics
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.
Measured: 24 hours
Secondary outcomes (6)
Total postoperative analgesic consumption.
Comparison between the three groups considering the amount of opioids consumed according to FLACC scale in the post operative period.
Measured: 24 hours
Time for extubation
Comparison between the three groups considering the effect of different pain control modalities on aiding fast track extubation.
Measured: 24 hours
Incidence of nausea
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.
Measured: 24 hours
Hemodynamic instability
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.
Measured: 24 hours
Onset of ambulation
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.
Measured: 24 hours
incidence of vomiting
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septal DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ahmed Hanee Abdelmohaimen Bakr, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873906
- Sponsor's protocol ID
- FMASU MD124/2024
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06873906
- Acronym / sponsor ID
- FMASU MD124/2024
- Conditions
- Septal Defect
- Keywords
- septal defect, acyanotic heart disease, median sternotomy, deep parasternal intercostal plane block, erector spinae plane block, eras
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep Parasternal Intercostal Plane Block | Active comparator | Procedure: Deep Parasternal intercostal plane blockPatients will receive bilateral deep parasternal intercostal plane block. |
| Erector Spinae plane block | Active comparator | Procedure: Erector Spinae Plane BlockPatients will receive bilateral erector spinae plane block |
| conventional analgesic regimen | Active comparator | Drug: conventional analgesic regimenpatients will receive conventional analgesic regimen |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients with acyanotic heart disease
- Patients with septal defect undergoing primary repair
- ASA Ⅰ and Ⅱ
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Parasternal intercostal plane blockPatients 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. | Procedure or surgery | Deep Parasternal Intercostal Plane Block |
| Erector Spinae Plane BlockPatients 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 | Procedure or surgery | Erector Spinae plane block |
| conventional analgesic regimenAnesthesia 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. | Drug | conventional analgesic regimen |
Primary outcome
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.
6 secondary outcomes
Total postoperative analgesic consumption.
Time frame: 24 hours
Time for extubation
Time frame: 24 hours
Incidence of nausea
Time frame: 24 hours
Hemodynamic instability
Time frame: 24 hours
Onset of ambulation
Time frame: 24 hours
incidence of vomiting
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep Parasternal intercostal plane block, Erector Spinae Plane Block and conventional analgesic regimen in people with Septal Defect, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah A. H. Bakr, Ms degree of Anesthesia ([202] 01062638487, sarahhanee@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of the first request for postoperative analgesics (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.