Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The total dose of intraoperative fentanyl boluses in microgram.
研究概览
简要总结
This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.
详细描述
Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the Erector spinae plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:6 months-7 years.
- •ASA, American Society of Anesthesiology, II and III .
- •Patients undergoing cardiac surgeries with midline sternotomy incision.
排除标准
- •Patients whose parents or legal guardians refusing to participate.
- •Preoperative mechanical ventilation.
- •Preoperative inotropic drug infusion.
- •Known or suspected coagulopathy.
- •Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
- •Known or suspected allergy to any of the studied drugs.
- •Elevated liver enzymes more than the normal values.
- •Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).
结局指标
主要结局
The total dose of intraoperative fentanyl boluses in microgram.
时间窗: 3 months
The total dose of intraoperative fentanyl boluses in microgram
次要结局
- Total consumption of morphine during the first 24 hours postoperatively.(3 monts)
- Pain assessment at postoperatively by FLACC score(3 months)
- extubation time(3 months)