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临床试验/NCT01401712
NCT01401712Unknown不适用

Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
试验地点
2
主要终点
Hospital length of stay/time to achieve discharge criteria

研究概览

简要总结

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.

An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.

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
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hospital length of stay/time to achieve discharge criteria

时间窗: Patient will be followed for the duration of hospital stay, 1 week

The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria: 1. Visual Analog Score (VAS) for pain below 4 (of a maximum 10); 2. Ability to perform incentive spirometry with sustained maximal inspiration for three seconds; 3. Hemodynamic stability (heart rate \<100 beats/min, respiratory rate \<20 breaths/min, and systolic blood pressure \>90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air; 4. Absence of neurological deficits; and 5. Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.

次要结局

  • Pain score reduction(Patient will be followed for duration of hospital stay and through daily phone calls upon discharge)

研究者

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

George Velmahos

Division Chief, Trauma, Emergency Surgery, Surgical Critical Care

Massachusetts General Hospital

研究点 (2)

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