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NCT Number: NCT06984276

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

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.

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Key information

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Abdelhay A Ebade, MD

SUB_INVESTIGATOR

Ahmed A Gado, MD

SUB_INVESTIGATOR

Ahmed K Mohammed, MD

SUB_INVESTIGATOR

Mahmoud M Elwakeel, MD

SUB_INVESTIGATOR

Mai M Elfiky, Master

CONTACT

[email protected]

00201110404608

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Control

Drug

Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.

Other names: Fentanyl

Pectoral nerves (PECS)

Other

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 names: Bupivacaine 0.25% and lidocaine 1%

Transversus thoracic muscle plane block (TTPB)

Other

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 names: Bupivacaine 0.25% and lidocaine 1%)

Primary outcomes

  1. The total dose of intraoperative fentanyl

    Time frame: Intraoperatively

    The total dose of intraoperative fentanyl will be recorded

Secondary outcomes

  1. Degree of pain

    Time frame: 12 hours postoperatively

    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 .

  2. Heart rate

    Time frame: 12 hours postoperatively

    Heart rate (HR) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours

  3. Mean arterial pressure

    Time frame: 12 hours postoperatively

    Mean arterial pressure (MAP) immediately after admission to Intensive Care Unit (ICU) then at 60 min, 2 hours, 4hours, 8 hours and 12 hours

  4. Total consumption of Fentanyl

    Time frame: 12 hours postoperatively

    Total consumption of Fentanyl during the 1st 12 hours postoperatively will be recorded

  5. Time to 1st rescue analgesia

    Time frame: 12 hours postoperatively

    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.

  6. Time of Extubation

    Time frame: 12 hours postoperatively

    Time of Extubation will be recorded

  7. The incidence of opioid complications

    Time frame: 12 hours postoperatively

    The incidence of opioid complications like postoperative nausea and vomiting (PONV), hematoma formation, itching will be recorded

  8. The incidence of Local anatectic toxicity

    Time frame: 12 hours postoperatively

    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.

Study contacts

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

Mai M Elfiky, Master

CONTACT

[email protected]

00201110404608

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 30, 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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