Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery
- Conditions
- Pediatric PatientsCongenital Heart Surgery
- Interventions
- Other: Ultrasound-guided bilateral pecto-intercostal fascial blockDevice: ultrasound
- Registration Number
- NCT04945694
- Lead Sponsor
- Mansoura University
- Brief Summary
Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.
In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.
Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.
- Detailed Description
The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- On pump
- Elective repair of congenital simple left to right intracardiac shunt
- Median sternotomy
- Refusal of their guardians
- Redo cardiac surgery
- Previous back injury
- Previous back surgery
- Kyphoscoliosis
- Local infection of the skin and subcutaneous tissue at the site of needle puncture
- Hypersensitivity to local anesthetics
- Coagulation disorders
- Renal disease
- Hepatic disease
- Pulmonary disease
- Heart failure
- Moderate to severe pulmonary hypertension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound-guided bilateral pecto-intercostal fascial block Ultrasound-guided bilateral pecto-intercostal fascial block Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Ultrasound-guided bilateral pecto-intercostal fascial block Propofol Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Ultrasound-guided bilateral pecto-intercostal fascial block Sevoflurane Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Ultrasound-guided bilateral pecto-intercostal fascial block Atracurium Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Ultrasound-guided bilateral pecto-intercostal fascial block ultrasound Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block Intravenous fentanyl Intravenous fentanyl Patients will receive only incremental doses of intravenous fentanyl Intravenous fentanyl Propofol Patients will receive only incremental doses of intravenous fentanyl Intravenous fentanyl Sevoflurane Patients will receive only incremental doses of intravenous fentanyl Intravenous fentanyl Atracurium Patients will receive only incremental doses of intravenous fentanyl
- Primary Outcome Measures
Name Time Method Total dose of fentanyl requirements intraoperative and 24 hrs postoperatively Total dose of fentanyl requirements
Postoperative pain assessment Postoperative day 1 Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
- Secondary Outcome Measures
Name Time Method Serum cortisol levels Basal and one-hour postoperatively Heart rate [HR] before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum Invasive mean arterial blood pressure [MAP] before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Trial Locations
- Locations (1)
Mansoura University
🇪🇬Mansoura, DK, Egypt