NCT04344132Unknown不适用
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
University of Roma La Sapienza0 个研究点目标入组 50 人开始时间: 2020年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Visual Analogue Scale score at 24 h after surgery
研究概览
简要总结
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years),
- •presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia
排除标准
- •history of allergic reactions on local anesthetics;
- •ASA status ≥ 3;
- •depressed consciousness in pre- or postoperative period;
- •aphasia (as investigators were not able to obtain VAS score).
结局指标
主要结局
Visual Analogue Scale score at 24 h after surgery
时间窗: up to 24 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
次要结局
- Visual Analogue Scale score at 0(Baseline)
- Visual Analogue Scale score at 2 hours(up to 2 hours)
- Visual Analogue Scale score at 6 hours(up to 6 hours)
- Visual Analogue Scale score at 12 hours(up to 12 hours)
- time first request of a patient for rescue analgesia(during surgery)
- intraoperative anesthetics(during surgery time)
- awakening time(time from the end of surgery to awekening)
- changes in hemodynamics at mayfiled headfraom positioning(surgery)
研究者
Federico Bilotta
Principal investigator
University of Roma La Sapienza
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