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临床试验/NCT03670290
NCT03670290已完成不适用

Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

Mersin University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年12月15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
120
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.

详细描述

Hip fracture is one of the most serious consequences of falls in the elderly, with a mortality of 10% at one month and 30% at one year. Factors of associated with increased morbidity and mortality have been researched to prevent complications.

Pain has been associated with delirium and depression in hip fracture patients. Besides, narcotic drugs are also associated with some side effects such as delirium, postoperative nausea and vomiting (PONV ), cardiovascular and respiratory depression. These clinical problems are especially important in the elderly population.

Fascia iliaca compartment block (FICB) is one of the methods applied for postoperative analgesia, which is applied under the inguinal ligament and distributes between the femoral nerve and lateral femoral cutaneous nerve block by volumetric effect. Recently, studies have been published on hip fracture patients using pop up technique in emergency services. Although many studies have shown that FICB is effective in perioperative analgesia, the effects of this method on complications and mortality rate have not yet been investigated.

The primary objective is to compare morphine consumption and VAS scores in patients with hip fracture who treated with epidural catheter, fascia iliaca compartment catheter or patient controlled analgesia.

The secondary objective is to determine complications. The investigators hypothesize that FICB catheter will provide good pain control same as epidural catheter, and will decrease complications such as delirium and pain with less mortality rate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients without communication problems (delirium, hearing loss, language problems etc.)
  • Patients who do not use regular analgesic medication for any chronic disease
  • Patients without any neurological deficit at the lower extremity
  • Patients without renal or hepatic dysfunction
  • Patients without bleeding diathesis
  • Patients with isolated femur fractures

排除标准

  • Patients with communication problems
  • Patients who use regular analgesic medication for any chronic disease
  • Patients with neurological deficits in the lower extremity
  • Patients with renal or hepatic dysfunction
  • Patients with bleeding diathesis
  • Patients with multiple trauma

结局指标

主要结局

Morphine consumption

时间窗: From the beginning of treatment to discharge (Totally 5 days)

All perioperative morphine consumption will be recoreded every 6 hours.

Visual analogue score

时间窗: From admission to second postoperative day. (Totally 5 days)

Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.

次要结局

  • incidence of postoperative complications in 30 day post-surgery.(From end of surgery to Day 30 after surgery (totally 30 days))

研究者

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

Mustafa Azizoğlu

Assistant Proffessor

Mersin University

研究点 (1)

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