Impact of Ultrasound Guided Erector Spine Plane & Caudal Block For Postoperative Analgesia In Pediatric Lower Limb Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg.
In both groups , ultrasound guided block will be performed by an experienced anesthesiologist who has no subsequent role in the study after induction of anesthesia and before starting of surgery in lateral position, sterilized and covered with sterile sheets. Aseptic precautions is taken by wearing sterile gowns and gloves A sterile preparation of the ultrasound probe is obligatory. Outcome parameters will be assessed by another anesthesiologist blinded to the groups of assignment.
Group 1: group of ultrasound guided Erector spine plane block:
Group 11: group of ultrasound guided Cauda block:
详细描述
Ethical considerations:
- After approval from institutional ethics committee, an informed consent will be obtained from all parents of participants in this research. All data of patients will be confidential with secret codes and private file for each patient, and all given data will be used for the current medical research only.
- Any unexpected risks appear during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks Patients will be randomized into two equal groups at a ratio of 1:1 to receive either Erector spine plane block (Group I n= 25) or Caudal block (Group II n= 25).
Randomization will be performed using sealed opaque envelopes indicating the group of assignment. A blinded nurse, who will not participate in the study or data collection, read the number contained in the envelope and made group assignments.
A preoperative evaluation in form of history taking, clinical examination and routine laboratory investigations, On arrival to the operating room, an intravenous (IV) cannula 24-22 gauge will be inserted and standard monitoring in terms of electrocardiogram (ECG), non-invasive blood pressure, capnograph and pulse oximeter for oxygen saturation (SpO2) will be connected to each participants. Patient received ,05mg midazolam and 4 mg ondansetron.
Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
neither investigator nor outcome assessors know which block patient had received
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 2-15years old,
- •classified by the American society of anesthesiologists as ASA I and II
- •who will be scheduled for elective lower limb surgery will be enrolled in our study.
排除标准
- •Parents refusal,
- •spine or chest wall deformity,
- •coagulation disorders, ,
- •known respiratory and cardiac disorders, renal or hepatic insufficiency
- •known allergy to study drugs, uncooperative patients.
研究组 & 干预措施
group 1
group of ultrasound guided Erector spine plane block:
干预措施: erector spinae plane block (Procedure)
group 2
group of ultrasound guided Caudal block:
干预措施: ultrasound guided caudal block (Procedure)
结局指标
主要结局
pain score
时间窗: in first 24 hours postoperatively
pain will be assessed using Face, Legs, Activity, Cry, and Consolability (FLACC) or Numeric Rating Scale (NRS) scores
次要结局
- total postoperative analgesic requirement(first 24 hours postoperatively)
研究者
Wafaa Madhy Atia Abdelwahed
principle investigator
Tanta University