CHD - Congenital Heart DiseaseNCT06958120
Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block
A study testing superficial parasternal intercostal Plane block and Erecto spinea plane block in people with CHD - Congenital Heart Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- CHD - Congenital Heart Disease
- What is being tested?
- superficial parasternal intercostal Plane block and Erecto spinea plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Feb 2027
- Phase
- Interventional
- 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 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- RACHS-1: Categories 1, 2 and 3
- Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
- Redo surgeries.
Who cannot join
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Coagulopathy.
- Allergy to any of the studied drugs.
- Severe pulmonary hypertension (> 70 mmHg).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Abu Al reesh hospital
Cairo
Cairo University hospitals, +20223643524, website@kasralainy.edu.eg
About this study
Official title: Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study
Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3.
Group (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
Read the detailed description
Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment
- Conditions
- CHD - Congenital Heart Disease
- Being tested
- superficial parasternal intercostal Plane block, Erecto spinea plane block
- Keywords
- CHD, Regional anaesthesia, Pain management
- Medical subject headings
- Heart Defects, Congenital, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial parasternal intercostal Plane blockProcedure or surgery
A high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs.
Erecto spinea plane blockProcedure or surgery
Using ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane.
| Study group | Role | What they receive |
|---|---|---|
| Superficial parasternal intercostal Plane block group | Experimental | This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block Receives: Procedure: superficial parasternal intercostal Plane block |
| Erecto-Spinea plane block group | Experimental | This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral Erecto-Spinea plane block Receives: Procedure: Erecto spinea plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain was assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.
Measured: Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mahrous, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958120
- Sponsor's protocol ID
- BLocks in pediatric cardiac op
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06958120
- Acronym / sponsor ID
- BLocks in pediatric cardiac op
- Conditions
- CHD - Congenital Heart Disease
- Keywords
- CHD, Regional anaesthesia, Pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 May 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.
Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3.
Group (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
Detailed description
Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial parasternal intercostal Plane block group | Experimental | Procedure: superficial parasternal intercostal Plane blockThis group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block |
| Erecto-Spinea plane block group | Experimental | Procedure: Erecto spinea plane blockThis group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral Erecto-Spinea plane block |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- RACHS-1: Categories 1, 2 and 3
- Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
- Redo surgeries.
Key exclusion criteria (6 listed)
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Coagulopathy.
- Allergy to any of the studied drugs.
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 |
|---|---|---|
| superficial parasternal intercostal Plane blockA high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs. | Procedure or surgery | Superficial parasternal intercostal Plane block group |
| Erecto spinea plane blockUsing ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane. | Procedure or surgery | Erecto-Spinea plane block group |
Primary outcome
Pain assessment
Time frame: Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively
Pain was assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. yes
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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 study testing superficial parasternal intercostal Plane block and Erecto spinea plane block in people with CHD - Congenital Heart Disease, run by Cairo 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 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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.
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 Reham Mahrous, MD (+201006211832, dr_memoo2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively). 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 10 Sep 2026.