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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

ConditionsUltrasoundPectoral Nerve BlockTransverse Thoracic Plane BlockPediatric PatientsCorrective Cardiac SurgeriesCardiopulmonary BypassMedian Sternotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-7
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control

    Drug

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

  • Pectoral nerves (PECS)

    Other intervention

    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 intervention

    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 .

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Pectoral nerves groupExperimental treatment 1 intervention
Group C: Transversus thoracic muscle plane block groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The total dose of intraoperative fentanyl

The total dose of intraoperative fentanyl will be recorded

Time frame
Intraoperatively

Secondary outcomes

1

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 .

Time frame
12 hours postoperatively
2

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

Time frame
12 hours postoperatively
3

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

Time frame
12 hours postoperatively
4

Total consumption of Fentanyl

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

Time frame
12 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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