UltrasoundNCT06984276
Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy
A study testing Pectoral nerves (PECS) and Transversus thoracic muscle plane block (TTPB) in people with Ultrasound and Pectoral Nerve Block, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Ultrasound, Pectoral Nerve Block, Transverse Thoracic Plane Block
- What is being tested?
- Pectoral nerves (PECS) and Transversus thoracic muscle plane block (TTPB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2024to 30 Dec 2025
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 months - 7 years.
- Gender: both sexs .
- Risk Adjustment for Congenital Heart Surgery (RACHS) II and III.
- Patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision.
Who cannot join
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour.
- Preoperative inotropic drug infusion.
- (Bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation [DIC]), coagulopathy: Partial Thromboplastin Time (PTT) > 40 seconds, International Normalized Ratio (INR) > 1.4, platelet count < 100x10⁹.
- Known or suspected allergy to any of the studied drugs.
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- Severe pulmonary hypertension (mean resting blood pressure in pulmonary arteries is above 70mmHg).
- Cardiopulmonary bypass time more than 90 minutes.
- local infection.
- Significant Renal impairment (creatinine more than 1.2mg/dl)
- Aortic cross-clamp time more than 45 minutes.
- Total time from induction till intensive Care Unit (ICU) transfer more than 4 hours and 30 mins.
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
Cairo University
Cairo, 12613
Mai M Elfiky, Master, 00201110404608, maielfiky45@gmail.com
Abdelhay A Ebade, MD
About this study
Official title: Efficacy Of Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy: A Randomized Controlled Trial.
This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.
Read the detailed description
Good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the Intensive Care Unit (ICU). Traditional use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids associated with adverse effect commonly used for pain control postoperative.
The transversus thoracic muscle plane block (TTPB) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by Ueshima et al. in 2015 .
The pectoral nerves (PECS) block has evolved to be two different types: PECS I and PECS II. In PECS I block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. The PECS II block, which was also developed by Blanco in 2012.
The PECS block has been well established for its use in breast surgery for the adult population. , However, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.
- Conditions
- Ultrasound, Pectoral Nerve Block, Transverse Thoracic Plane Block, Pediatric Patients, Corrective Cardiac Surgeries, Cardiopulmonary Bypass
- Being tested
- Control, Pectoral nerves (PECS), Transversus thoracic muscle plane block (TTPB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDrug
Also called Fentanyl
Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.
Pectoral nerves (PECS)Other
Also called Bupivacaine 0.25% and lidocaine 1%
This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
Transversus thoracic muscle plane block (TTPB)Other
Also called Bupivacaine 0.25% and lidocaine 1%)
This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. Receives: Drug: Control |
| Pectoral nerves group | Experimental | This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . Receives: Other: Pectoral nerves (PECS) |
| Transversus thoracic muscle plane block group | Experimental | This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . Receives: Other: Transversus thoracic muscle plane block (TTPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of intraoperative fentanyl
The total dose of intraoperative fentanyl will be recorded
Measured: Intraoperatively
Secondary outcomes (8)
Degree of pain
Pain will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score immediately after admission to intensive care unit (ICU) then at 60 min, 2 hours, 4hours, 8hours and 12 hours postoperatively.
If the patient FLACC score equal or more than 4, patient will receive Fentanyl I.V 1 mic /kg .
Measured: 12 hours postoperatively
Heart rate
Heart rate (HR) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours
Measured: 12 hours postoperatively
Mean arterial pressure
Mean arterial pressure (MAP) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours
Measured: 12 hours postoperatively
Total consumption of Fentanyl
Total consumption of Fentanyl during the 1st 12 hours postoperatively will be recorded
Measured: 12 hours postoperatively
Time to 1st rescue analgesia
Time to 1st rescue analgesia post operatively which will be defined to be the elapsed time between giving the block and a patient FLACC score equal or more than 4.
Measured: 12 hours postoperatively
Time of Extubation
Time of Extubation will be recorded
Measured: 12 hours postoperatively
The incidence of opioid complications
The incidence of opioid complications like postoperative nausea and vomiting (PONV), hematoma formation, itching will be recorded
Measured: 12 hours postoperatively
The incidence of Local anatectic toxicity
The incidence of Local anatectic toxicity like neurologic symptoms (seizures, and ultimately neurologic depression with respiratory arrest, coma, or both) and Cardiovascular symptoms may include an hypertensive , tachycardia, cardiac depression with bradycardia, myocardial depression, conduction block, asystole, and cardiac arrest.
Measured: 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 posted22 May 2025
- Study start30 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Mahmoud Elfiky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984276
- Sponsor's protocol ID
- MD-263-2024
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06984276
- Acronym / sponsor ID
- MD-263-2024
- Conditions
- Ultrasound, Pectoral Nerve Block, Transverse Thoracic Plane Block, Pediatric Patients, Corrective Cardiac Surgeries, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 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.
This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.
Detailed description
Good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the Intensive Care Unit (ICU). Traditional use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids associated with adverse effect commonly used for pain control postoperative.
The transversus thoracic muscle plane block (TTPB) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by Ueshima et al. in 2015 .
The pectoral nerves (PECS) block has evolved to be two different types: PECS I and PECS II. In PECS I block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. The PECS II block, which was also developed by Blanco in 2012.
The PECS block has been well established for its use in breast surgery for the adult population. , However, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: ControlPatients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. |
| Pectoral nerves group | Experimental | Other: Pectoral nerves (PECS)This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . |
| Transversus thoracic muscle plane block group | Experimental | Other: Transversus thoracic muscle plane block (TTPB)This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6 months - 7 years.
- Gender: both sexs .
- Risk Adjustment for Congenital Heart Surgery (RACHS) II and III.
- Patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision.
Key exclusion criteria (12 listed)
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour.
- Preoperative inotropic drug infusion.
- (Bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation [DIC]), coagulopathy: Partial Thromboplastin Time (PTT) > 40 seconds, International Normalized Ratio (INR) > 1.4, platelet count < 100x10⁹.
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 |
|---|---|---|
| ControlAlso: FentanylPatients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. | Drug | Control group |
| Pectoral nerves (PECS)Also: Bupivacaine 0.25% and lidocaine 1%This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . | Other | Pectoral nerves group |
| Transversus thoracic muscle plane block (TTPB)Also: Bupivacaine 0.25% and lidocaine 1%)This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side . | Other | Transversus thoracic muscle plane block group |
Primary outcome
The total dose of intraoperative fentanyl
Time frame: Intraoperatively
The total dose of intraoperative fentanyl will be recorded
8 secondary outcomes
Degree of pain
Time frame: 12 hours postoperatively
Heart rate
Time frame: 12 hours postoperatively
Mean arterial pressure
Time frame: 12 hours postoperatively
Total consumption of Fentanyl
Time frame: 12 hours postoperatively
Time to 1st rescue analgesia
Time frame: 12 hours postoperatively
Time of Extubation
Time frame: 12 hours postoperatively
The incidence of opioid complications
Time frame: 12 hours postoperatively
The incidence of Local anatectic toxicity
Time frame: 12 hours postoperatively
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 30 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year
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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 Pectoral nerves (PECS) and Transversus thoracic muscle plane block (TTPB) in people with Ultrasound and Pectoral Nerve Block, 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 4 inclusion and 12 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 30 May 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.
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 Mai M Elfiky, Master (00201110404608, maielfiky45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total dose of intraoperative fentanyl (time frame: Intraoperatively). 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 30 May 2025.