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临床试验/NCT05506501
NCT05506501Unknown不适用

Comparative Study Between Intentional Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction Undergoing Insertion of Nail Tibia for Fixation of Fracture Shaft Tibia

Ain Shams University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
mean blood pressure

研究概览

简要总结

compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

详细描述

Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 60 years old.
  • Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
  • Patients with low ejection fraction (30-40%).

排除标准

  • Patient refusal
  • Uncooperative patient
  • Unconscious patients
  • Cases with head trauma
  • History of relevant drug allergy to local anesthetics
  • Local infection at the site of the block
  • Patients with coagulopathies and impaired platelet functions
  • Patients with hemodynamic instability
  • Previous neurological deficit in lower limb and previous femoral artery grafts or injuries.

结局指标

主要结局

mean blood pressure

时间窗: 20 minutes after anesthesia

次要结局

  • time of first analgesic request(within 24 hours after the block)
  • adequate motor block(15 minutes after the block)
  • adequate sensory block(20 minutes after the block)

研究者

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

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (2)

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