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临床试验/NCT04344132
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

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Bilotta

Principal investigator

University of Roma La Sapienza

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