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临床试验/NCT04996524
NCT04996524已完成不适用

Epidural vs. Systemic Analgesia in the Intensive Care Unit: Retrospective Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 647 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
647
试验地点
1
主要终点
delirium score

研究概览

简要总结

Many patients admitted to the general intensive care unit suffer from pain, whether acute or chronic. Those patients include post-operative patients, multi trauma, acute pancreatitis and patients with multiple rib fractures. Most patients in the intensive care unit, whether intubated and ventilated or not, are treated with systemic analgesic drugs, usually given intravenously, enterally, or trans dermally (fentanyl patches).

Continuous epidural anesthesia has been shown in several studies to have an advantage over systemic analgesia in specific conditions, such as pancreatitis, multiple rib fractures and upper abdominal surgeries. Some of its benefits include improved gastrointestinal motility (reduction of ileus rates), decreased thromboembolic events (DVT) and better quality of pain control. In intubated and ventilated patients, continuous epidural anesthesia may reduce the amount of required systemic sedation. Reducing the amount of sedation may contribute to a decrease in delirium rates, shortening the time to extubation and reducing other adverse effects associated with high requirements of sedation drugs (such as a decrease in blood pressure).

Most of the studies comparing systemic analgesia to epidural analgesia examined a population of patients hospitalized in the surgical ward, post breast, abdominal or orthopedic surgeries of the pelvis and lower extremities, or due to other conditions such as pancreatitis or multiple rib fractures. There are almost no studies that have examined the effectiveness of epidural analgesia in patients admitted to the intensive care unit, including sedated and ventilated patients, compared with systemic analgesia.

From 2011 until today, our intensive care unit has admitted about 300 patients who were treated with continuous epidural analgesia. In this study we would like to compare them to another group of patients (about 300 patients as well), who were admitted to the unit for similar etiologies (post-operative, multi- trauma, pancreatitis, etc.), and to observe differences between the groups. We would like to examine differences in mortality within 28 days, as well as differences in morbidity, such as the level of analgesia and delirium rates between groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-99, admitted to the General Intensive Care Unit from January 2011 to June 2021 (inclusive), due to a medical condition that may expose them to significant pain during hospitalization: chest, abdominal, pelvic or lower extremity surgery, pancreatitis, multiple rib fractures, trauma including chest, abdominal, pelvic, or lower limb trauma, and treated with epidural or systemic anesthesia during their stay in the unit.

排除标准

  • Patients not admitted for the above reasons. -

研究组 & 干预措施

epidural analgesia group

Experimental

干预措施: epidural analgesia (Drug)

结局指标

主要结局

delirium score

时间窗: 6 months post ICU admission

To compare delirium score, as measured by RASS score, between the epidural group and the systemic analgesia group

次要结局

  • pain score(6 months post ICU admission)

研究者

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

sara dichtwald

Dr

Meir Medical Center

研究点 (1)

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