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临床试验/NCT05072184
NCT05072184已完成不适用

the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

Fayoum University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
The total intraoperative fentanyl consumption (μg)

研究概览

简要总结

This study aims to evaluate the effects of erector spinae plane block on intraoperative fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia.

To our knowledge, no study in the literature demonstrates this effect.

详细描述

This study will be performed in Fayoum University hospital after approval of the institutional ethics committee and written informed consent. This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.

Inclusion criteria:

  • American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
  • Age range above 18.

Exclusion criteria:

  • Patient refusal.
  • Significant renal, hepatic and cardiovascular diseases.
  • History of allergy to one of the study drugs.
  • Any contraindication to regional anesthesia such as local infection or bleeding disorders.
  • Chronic opioid use, history of chronic pain and cognitive disorders.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria:
  • American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
  • Age range 18-70 years

排除标准

  • Patient refusal.
  • Significant renal, hepatic, and cardiovascular diseases.
  • History of allergy to one of the study drugs.
  • Any contraindication to regional anesthesia such as local infection or bleeding disorders.
  • Chronic opioid use, history of chronic pain and cognitive disorders.

结局指标

主要结局

The total intraoperative fentanyl consumption (μg)

时间窗: operative time in hours

the total doses of intraoperative fentanyl consumption in (μg)

次要结局

  • post-operative fentanyl consumption in (μg)(the first 24 hours postoperative)
  • mean operative times (min)(operative times in (min))
  • VAS score(the first 24 hours postoperative)
  • intraoperative sevoflurane consumption (ml)(operative time in hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Hamed

Associate professor

Fayoum University Hospital

研究点 (2)

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