Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The total dose of postoperative operative fentanyl consumption in the first 24 hours.
研究概览
简要总结
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.
It is a randomized controlled trial.
详细描述
It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. 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 serratus anterior 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.
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 serratus anterior 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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months-3 years.
- •American Society of anesthesiology (ASA) I and II.
- •Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).
排除标准
- •Patients whose parents or legal guardians refusing to participate.
- •Preoperative mechanical ventilation.
- •Known or suspected coagulopathy.
- •Infection at the site of injection.
- •Known or suspected allergy to any of the studied drugs.
- •Elevated liver enzymes more than the normal values.
- •Procedures with anticipated significant hemodynamic stability.
- •Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).
研究组 & 干预措施
Serratus Anterior Plan block plus fentanyl infusion
The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.
干预措施: Serratus Anterior Plan Block+ Fentanyl infusion (Procedure)
Serratus Anterior Plan block plus fentanyl infusion
The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.
干预措施: Fentanyl (Drug)
Fentanyl infusion only
The patient will receive fentanyl infusion only.
干预措施: Fentanyl (Drug)
结局指标
主要结局
The total dose of postoperative operative fentanyl consumption in the first 24 hours.
时间窗: 12 months
The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated
次要结局
- Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.(12 months)
- Intraoperative and postoperative systolic blood pressure.(12 months)
- Total dosage of additional fentanyl boluses usage in micrograms intraoperatively(12 months)
- First rescue analgesia(12 months)
- Intra and postoperative heart rate.(12 months)
研究者
Ahmed Abdelaziz Ismail
Principle investigator
Cairo University