CTRI/2019/12/022337尚未招募不适用
POST OPERATIVE ANALGESIA USING TWO CONCENTRATIONS OF BUPIVACAINE(0.20% AND 0.15%) FOR CAUDAL EPIDURAL ANALGESIA (CEA) IN SEQUENTIAL CEA-SPINAL ANAESTHESIA IN CHILDREN POSTED FOR INFRA UMBILICAL SURGERIES
Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年12月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Postoperative analgesia characteristics between to groups
研究概览
简要总结
Post operative analgesia in paediatric patients includes using caudal epidural analgesia. Spinal Anaesthesia is used frequently for providing surgical anaesthesia for infra umbilical surgeries.
Combining both the techniques requires care in dosing requirements of local anaesthetic agents, to prevent toxicity.
Keeping this in mind, this trial is planned using two different doses of bupivacaine (0.15% and 0.20%) for caudal epidural along with standard dose for spinal anaesthesia.
First recruitment will start after approval by CTRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex posted for elective infra umbilical surgery 2) ASA physical status I & II 3) Age 2 to 8 years.
排除标准
- •Refusal by parents for the procedure 2) Children with spinal developmental anomalies 3) Significant coagulation, cardiovascular, respiratory, central nervous system or renal system disorders 4) Preexisting musculoskeletal disorders 5) Allergy to test drugs.
结局指标
主要结局
Postoperative analgesia characteristics between to groups
时间窗: Assessment every 15 min for for 6 hrs, every 30 mins for 12 hrs, every 4 hrs for 24 hrs
次要结局
- Use of supplements,PONV,Hemodynamic changes(every 15th minute for 3hrs, every 30 mins for 12 hrs,every 4 hrs till 24 hrs)
研究者
研究点 (1)
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