Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 3
- 主要终点
- Incidence of secondary chronic pain
研究概览
简要总结
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.
A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.
A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients.
Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes.
The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care.
Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •adults (>=18 y.o.)
- •hospitalized in the ICU for at least 48 hours
- •with SARS-Cov2 infection confirmed by Polymerase Chain Reaction (PCR)/serology and/or a suggestive chest Computed Tomography scan
- •during the first wave of COVID 19 from March to December 2020 at three investigator sites (2 in Paris and 1 in Lyon)
- •discharged alive from the ICU
- •at least 6 months after discharge
排除标准
- •patient refusal
- •inability to communicate or to have in-person appointment
- •death in the period from ICU discharge to the first phone call for interview
结局指标
主要结局
Incidence of secondary chronic pain
时间窗: starting 6 month after discharge
Secondary chronic pain as defined by International Classification of Disease -11th revision (ICD-11). Chronic secondary pain is organized into the following six categories: 1. Chronic cancer-related pain (ICD-11 code MG30.1) 2. Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2) 3. Chronic secondary musculoskeletal pain (ICD-11 code MG30.3) 4. Chronic secondary visceral pain (ICD-11 code MG30.4) 5. Chronic neuropathic pain (ICD-11 code MG30.5) 6. Chronic secondary headache or orofacial pain (ICD-11 code MG30.6) Any pain detected in the population of interest and fitting in one of 6 categories will be accounted.
次要结局
- Heat pain threshold(starting 6 month after discharge)
- Frequency of different secondary chronic pain classes(starting 6 month after discharge)
- Pain sensitivity level(starting 6 month after discharge)
- Neuropathic pain(starting 6 month after discharge)
- Anxiety and Depression(starting 6 month after discharge)
- Perceived Stress Level(starting 6 month after discharge)
- Pain localization(starting 6 month after discharge)
- The severity of pain and its impact on functioning(starting 6 month after discharge)
- Spiegel Sleep Quality Questionnaire(starting 6 month after discharge)
- Pain Catastrophizing Level(starting 6 month after discharge)
- Posttraumatic Stress Disorder(starting 6 month after discharge)
- Summation pain threshold(starting 6 month after discharge)
研究者
Mikhail Dziadzko, MD, PhD
Attending Pain Physician
Hôpital de la Croix-Rousse