Comparison of Ultrasound-Guided and Formula-Based Volume Determination for Caudal Block Analgesia in Pediatric Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Volume of 0.25% Ropivacaine (mL) required to achieve sensory block up to T10 dermatome level.
研究概览
简要总结
This randomised controlled trial compares ultrasound-guided and formula-based volume determination for caudal block analgesia in children aged 1 to 6 years undergoing infra-umbilical surgeries. 80 ASA I AND II patients will be randomly allocated into the two groups. In the ultrasound group, 0.25% Ropivacaine will be administered under real-time ultrasound guidance until spread is visualised up to the T10 level. In the modified Speigel formula group, the volume will be pre-calculated based on spinal height. The primary outcome is the volume of drug required to achieve a T10 sensory block. Secondary outcomes include postoperative pain score, duration of analgesia, maximum sensory level and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
入选标准
- •Pediatric patients of either Gender aged between 1 and 6 years American Society of Anaesthesiologists (ASA) physical status I, II Patients undergoing infra-umbilical surgery.
排除标准
- •Refusal to participate Allergy to local anaesthetic Coagulopathy Infection at the injection site Lumbosacral deformity Neurological disorders (e.g., cerebral palsy, developmental delay affecting sensory/motor assessment).
结局指标
主要结局
Volume of 0.25% Ropivacaine (mL) required to achieve sensory block up to T10 dermatome level.
时间窗: Assessed intra-operatively at the time of caudal block administration — from needle insertion to completion of drug injection (approximately 0–6 minutes).
次要结局
- Post-operative pain using FLACC (Face, Legs, Activity, Cry, Consolability) score(Postoperatively at 5, 10, 15, 20, 25, and 30 minutes, and then hourly up to 24 hours)
- Maximum sensory block level achieved(Within 30 minutes after caudal block, tested by response to cold stimulus using spirit-soaked cotton; absence of response recorded as level of sensory block.)
- Incidence of adverse effects (hypotension, bradycardia, motor weakness, urinary retention, local anaesthetic toxicity)(intraoperative and up to 24 hours postoperatively)
- Motor block assessment using Modified Bromage Scale(Every 5 minutes up to 30 minutes post-block)
- Duration of Post-operative Analgesia(Duration of Analgesia from completion of block until first rescue analgesia ( when FLACC score is more than or equal to 4))
研究者
Dr. Akanksha Tyagi
All India Institute of Medical Sciences, Rishikesh