Comparison of Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Mean arterial blood pressure intraoperatively from baseline till skin incision
研究概览
简要总结
Although scalp nerve blocks have been shown to provide effective postoperative analgesia in pediatric neurosurgical procedures, limited data exist on their use under ultrasound guidance. The smaller anatomical structures and higher vascularity of the pediatric scalp increase the risk of inadvertent vessel puncture or systemic toxicity with landmark-based techniques. Ultrasound guidance enables direct visualization of the targeted nerves and adjacent vessels, potentially improving block accuracy and safety. To date, no randomized controlled trial has compared ultrasound-guided versus conventional scalp block specifically in pediatric supratentorial tumor surgeries. This study aims to fill this gap.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II.
- •Undergoing elective supratentorial tumor surgery under general anesthesia on one side of the head.
排除标准
- •Urgent/emergency craniotomy.
- •Coagulopathy or platelet dysfunction.
- •Allergy to local anesthetics.
- •Pre-existing bradycardia (HR <60 bpm in infants, <50 bpm in older children) or unstable arrhythmias.
- •Severe hepatic/renal impairment.
研究组 & 干预措施
Ultrasound-guided scalp block using bupivacaine
patients will recieve ultrasound-guided scalp block using bupivacaine
干预措施: Ultrasound-guided scalp block (Procedure)
conventional scalp block using bupivacaine
patients will recieve conventional scalp block with bupivacaine using a landmark-based technique
干预措施: conventional scalp block (Procedure)
结局指标
主要结局
Mean arterial blood pressure intraoperatively from baseline till skin incision
时间窗: from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
The mean arterial blood pressure recorded during 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
次要结局
- Duration of analgesia(24 hours postoperatively)
- objective pain scale(2, 4, 6, 8, 12, 16, and 24 hours postoperatively)
- Total doses of ketorolac(24 hours postoperatively)
- 6. Total dose of paracetamol(24 hours postoperatively)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University