A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- In-hospital Delirium
研究概览
简要总结
This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).
详细描述
Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission.
Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission.
Sample size : 210 patients per group (drop out 10%) total 420 patients
Statistical analysis
SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals
- •Planed for fast-track hip surgery
- •Isolated acute hip fracture
- •Pain on admission during movement ≥ 4 (moderate pain)
排除标准
- •refusal to participate the study
- •ASA physical status >III
- •duration of fracture more than 7 days before admission
- •hip fracture after/at previous instrumentation
- •hip fracture causing by a traffic accident or high energy force
- •suspected pathologic fracture
- •unable to communication
- •abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia
- •allergy to local anesthetic drug
结局指标
主要结局
In-hospital Delirium
时间窗: In hospital admission, assess up to 30 days
Incidence of delirium using Nursing Delirium Screening Scale (NU-DESC) Thai version plus backward counting 30-1. Total Scale 11 ( \> or = 2 means delirium). The patient will be assessed once a day in the morning period.
次要结局
- Preoperative pain score(48 hours after hospital admission)
- Major adverse cardiac events(In hospital admission, up to 30 days)
- Predict 30-day mortality in hip fracture patient with multiple comorbidities(On admission day)
- Postoperative morphine consumption(Until postoperative 72 hours)
- In-hospital morbidities(In hospital admission, up to 30 days)
- Discharge hospital status(On hospital discharge day, up to 30 days)
- Post-operative pain score(Until postoperative 72 hours)
- Preoperative morphine consumption(48 hours after hospital admission)
- 30 days mortality(In hospital admission, up to 30 days)
- Length of hospital stay(In hospital admission, up to 30 days)
- In-hospital mortality rate(In hospital admission, up to 30 days)