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临床试验/NCT06395987
NCT06395987尚未招募不适用

Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures

Assiut University0 个研究点目标入组 60 人开始时间: 2025年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
• Success of wide-awake local anaesthesia in fixation of ankle fractures by measuring the amount of failure of wide awake local anesthesia

研究概览

简要总结

to assess the success of wide-awake local anaesthesia In fixation of ankle fractures

详细描述

The wide-awake local anesthesia with no tourniquet provides an alternative method for the existing anesthesia methods including general anesthesia, intrathecal, epidural anesthesia, peripheral nerve block and local anesthesia with intravenous sedation. Each method of them has its inherent risks and costs.

The wide-awake local anesthesia has few risks for the patient and can be used in satisfaction where other types of anesthesia particularly general anesthesia are contraindicated.

This method is safe, effective and provides satisfactory pain and anxiety scores. Patients don't have to stay for a long time after surgery. It allows the surgery to be done without tourniquet due to the use of epinephrine and this avoids the complication of tourniquet and allows the surgery to be done safely in cases of limb vascular insufficiency and in diabetic patients where tourniquet usage is not favorable.

Wide awake local anesthesia method for ankle fracture management is not a novel idea; it was previously investigated in one study but the limitation of this study that it was retrospective study with small sample size and without control group treated with other anesthetic modalities.

There is concern that the use of lidocaine in hematoma block is harmful for joint cartilage. Excess use of epinephrine may cause excessive vasoconstriction and cyanosis of fingers . Neuropathic complication are notably high during the early postsurgical period .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • All adult patients with unstable ankle fracture who need fixation presenting to the Trauma Unit of Assiut University Hospital with the following criteria:
  • Age ≥ 18 years.
  • Isolated ankle fracture in one or both lower limbs.

排除标准

  • patients< 18 years.
  • Patients with uncontrolled diabetes mellitus.
  • open fractures.
  • Associated fractures in the lower limbs(Spinal anaesthesia will be more suitable in multiple fractures)
  • Fractures managed by closed contact casting.
  • Patients with dementia and psychological disease.

结局指标

主要结局

• Success of wide-awake local anaesthesia in fixation of ankle fractures by measuring the amount of failure of wide awake local anesthesia

时间窗: Follow up for 6 months to assess if there is any complications .

Measure the success rate of wide awake inrelarion to failed cases

次要结局

未报告次要终点

研究者

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

Abdallah Sayed Shahata

Assistant Lecturer

Assiut University

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