Etude de la prévalence de la Douleur Chronique et de Ses Facteurs de Risque après Une Hospitalisation en réanimation Chirurgicale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of patients suffering from chronic pain 3 months after ICU discharge
研究概览
简要总结
The objective of this observational, prospective study is to evaluate the incidence of chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ≥3 days).
Investigators will assess the proportion of patients with chronic pain (defined according to the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge.
All data potentially associated with chronic pain will be collected, including the type of surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of opioids received, patients comorbidity...
Patients will be follow-up at 6 and 12 months to identify impact on quality of life.
详细描述
Acute pain is common for ICU patients, with an incidence of 33% at rest and of 56% during nursing care. However, there is few if any data on chronic pain after an ICU stay (ie lasting more than 3 months after ICU discharge), while chronic pain seems to be frequent in patients, in particular following surgeries. Indeed, several studies have shown that in postoperative period, many patients suffer from chronic pains, with incidence from 12 to more than 50 %, depending on surgery.
Known risk factors include:
- Female gender
- young age
- mental disorder antecedent
- pain prior to surgery
- type of anesthesia, including the type and dose of opioids used
- not correctly controlled severe pain
- prolonged pain
Chronic pain is becoming a public health problem, because of its impact on patients quality of life, but also on the over consumption of opioids as a result, and the addiction that arise.
Chronic pain following an ICU stay as been studied so far. Available studies in ICU are mainly interested in the quality of life, which remains altered even many years after ICU discharge. The most popular survey is the SF-36 which includes a section on chronic pain. However no study, to the best of our knowledge, were interested in chronic pain prevalence and in its risk factors after an ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Hospitalisation in ICU for ≥ 3 days
- •Affiliation to French health care coverage
- •Oral informed consent of the patient
排除标准
- •Patient with chronic pain at inclusion :defined as a prescription of pain killers (level 2 or 3), for more than 3 months
- •Cancer with life expectancy < 6 months
- •Neurological status not allowing to answer surveys
- •Pregnant, nursing or parturient women
- •Adult deprived of liberty by court judgment or administrative
- •Adult patient protected under the law (guardianship)
- •Adult with forced psychiatric care
结局指标
主要结局
Proportion of patients suffering from chronic pain 3 months after ICU discharge
时间窗: 3 months
Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) at 3 months after ICU discharge
次要结局
- Proportion of patients suffering from chronic pain at 6 and 12 months after ICU discharge discharge(12 months)
- Proportion of patients with possible depressive episode at 3, 6 and 12 months after ICU discharge(12 months)