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临床试验/NCT03741348
NCT03741348已完成不适用

Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Study

Fayoum University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Fentanyl consumption

研究概览

简要总结

The aim of this study was to assess the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing total abdominal hysterectomy under general anesthesia.

详细描述

60 patients Scheduled for elective total abdominal hysterectomy, after obtaining a written informed consent for anesthesia from each patient before enrolment in the study after explaining to them the nature of study.

Inclusion criteria included female patients aged 40 - 70 years, Weighted 50 - 90 Kg and with American society of anesthesiologists physical status (ASA) class Ι to ΙΙΙ Scheduled for elective total abdominal hysterectomy under general anesthesia. Exclusion criteria included Local infection at the site of puncture, Patients having history of hematological disorders, including coagulation abnormality, Patients with severe hepatic impairment, Patients with chronic pain and Patient had a known allergy to study drugs.

Patients were randomized into two equal groups. An online randomization program was used to generate random number list. Patient randomization numbers were concealed in opaque envelops which were opened by the study investigator.

Members of the study group involved in obtaining functional data were blinded to randomization for the period of data acquisition and analysis. Patients were randomly allocated into two groups:

Erector spinae plane block Group (ES): ultrasound guided erector spinae plane block at T9 vertebrae level with 20 ml of bupivacaine 0. 5%. Control Group (c): did not receive block.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • female patients
  • Aged 40 - 70 years,
  • Weighted 50 - 90 Kg
  • American society of Anesthesiologists physical status (ASA) class Ι to ΙΙΙ
  • Scheduled for elective total abdominal hysterectomy under general anesthesia

排除标准

  • Local infection at the site of puncture
  • Patients having a history of hematological disorders, including coagulation abnormality
  • Patients with severe hepatic impairment
  • Patients with chronic pain
  • A patient had a known allergy to study drugs.

研究组 & 干预措施

ES

Active Comparator

Erector Spinae Plane Block

干预措施: Erector Spinae Plane Block (Procedure)

control

Placebo Comparator

the control group will not receive block

干预措施: control (Procedure)

结局指标

主要结局

Fentanyl consumption

时间窗: first 24 hours postoperative

in microgram

次要结局

  • Visual analog score(24 hours postoperative)

研究者

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

Mohamed hamed

lecturer of anesthesia

Fayoum University

研究点 (2)

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