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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. |
|
| 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 . |
|
| 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Drug | Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total dose of intraoperative fentanyl | The total dose of intraoperative fentanyl will be recorded | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | 12 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai M Elfiky, Master | Contact | 00201110404608 | maielfiky45@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year
After the end of study for one year
The data will be available upon a reasonable request from the corresponding author
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| 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 . |
|
|
| 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 . |
|
|
| 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 | 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 | 12 hours postoperatively |
| Total consumption of Fentanyl | Total consumption of Fentanyl during the 1st 12 hours postoperatively will be recorded | 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. | 12 hours postoperatively |
| Time of Extubation | Time of Extubation will be recorded | 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 | 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. | 12 hours postoperatively |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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