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临床试验/NCT04404959
NCT04404959Unknown不适用

Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Aretaieion University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年5月10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
pain score 30 minutes after fascia iliaca block

研究概览

简要总结

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

详细描述

Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia.

Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied.

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
75 Years 至 105 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • geriatric patients
  • American Society of Anesthesiologists (ASA) I-III
  • hip fracture patients

排除标准

  • communication or language barriers
  • patients with nutritional problems
  • bedridden patients

结局指标

主要结局

pain score 30 minutes after fascia iliaca block

时间窗: 30 minutes after performance of fascia iliaca block

pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

pain score 12 hours after fascia iliaca block

时间窗: 12 hours after performance of fascia iliaca block

pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

次要结局

  • pain score 1-8 days after fascia iliaca block(1-8 days after fascia iliaca block)

研究者

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

Dr Kassiani Theodoraki

Professor of Anesthesiology

Aretaieion University Hospital

研究点 (2)

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