Comparative study of spinal anaesthesia versus caudal anaesthesia in paediatric patients undergoing infraumbilical surgeries
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the proportion of paediatric patients undergoing infraumbilical surgery in the Caudal & spinal anaesthesia groups who will achieve sensory blockade up to T6 level.
研究概览
简要总结
The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in pediatric patients satisfying all inclusion and exclusion Criteria planned for infraumbilical surgeries. Material used were Quincke type spinal needle of appropriate gauge, Sterile 2 cc and 5 ce syringes. Bupivacaine 0.5% Heavy ampoule, Bupivacaine 0.5% vial, Emergency drugs, IV Fluids, Anaesthesia workstation, suction apparatus Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.
The study population is divided into two groups of 18 each. Group S undergoing Spinal block and Group C undergoing Caudal block. Group S patients receives spinal anaesthesia via midline approach with patients in lateral position under aseptic precautions. After getting free flow of CSF hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg will be injected in the subarachnoid space. Group C patients I will be given caudal block with full aseptic precautions in left lateral position. Drug-0.5% plain bupivacaine 2mg/kg (1ml/kg according to modified Armitage formula) will be given.
The level of sensory blockade, Heart rate and MAP will be recorded preoperatively and at 5 minutes intervals intraoperatively, and after completion of the surgery. Surgical pain is evaluated through children and infant postoperative pain scale (CHIPPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anesthesiologist grade I
- •Pediatric cases scheduled for infraumbilical surgeries under spinal or caudal anaesthesia
- •Ages 2 to 10 years.
排除标准
- •Parent refusal
- •Infection at the site of injection
- •Coagulopathy
- •Increased intra-cranial pressure
- •Allergy to local anesthetics
- •Spinal deformities such as spina bifida and myelomeningocele
- •Sever aortic and mitral stenosis
- •Shock (haemorrhagic, septic).
结局指标
主要结局
To compare the proportion of paediatric patients undergoing infraumbilical surgery in the Caudal & spinal anaesthesia groups who will achieve sensory blockade up to T6 level.
时间窗: Till 60 mins post operatively
次要结局
- 1. To compare Hemodynamics in both the techniques(2. To compare post-operative analgesia in both the techniques)