Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total dose of fentanyl requirements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective repair of congenital simple left to right intracardiac shunt
- •Median sternotomy
排除标准
- •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.
研究组 & 干预措施
Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
干预措施: Ultrasound-guided bilateral pecto-intercostal fascial block (Other)
Intravenous fentanyl
Patients will receive only incremental doses of intravenous fentanyl
干预措施: Sevoflurane (Drug)
Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
干预措施: Propofol (Drug)
Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
干预措施: Sevoflurane (Drug)
Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
干预措施: Atracurium (Drug)
Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
干预措施: ultrasound (Device)
Intravenous fentanyl
Patients will receive only incremental doses of intravenous fentanyl
干预措施: Intravenous fentanyl (Drug)
Intravenous fentanyl
Patients will receive only incremental doses of intravenous fentanyl
干预措施: Propofol (Drug)
Intravenous fentanyl
Patients will receive only incremental doses of intravenous fentanyl
干预措施: Atracurium (Drug)
结局指标
主要结局
Total dose of fentanyl requirements
时间窗: intraoperative and 24 hrs postoperatively
Total dose of fentanyl requirements
Postoperative pain assessment
时间窗: Postoperative day 1
Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
次要结局
- 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)