Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 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
- 否
入选标准
- •Age ≥ 18 years;
- •Three or more rib fractures;
- •Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
- •Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
- •Patient has capacity to provide informed consent, as determined by:
- •Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
- •Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.
排除标准
- •Lack capacity to provide informed consent;
- •Intubation at time of enrollment;
- •Contraindications to procedure (e.g. known allergy to local anesthetics).
- •Presence of infection at site of catheter placement;
- •Current use of anticoagulant medication;
- •Known allergy to silver;
- •Inability to obtain informed consent;
- •Body weight > 300 lbs;
- •Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).
- •All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.
研究组 & 干预措施
Thoracic epidural catheter
干预措施: Thoracic epidural catheter (Procedure)
Paravertebral catheter (ON-Q® Pain Relief System)
干预措施: ON-Q® Pain Relief System (Procedure)
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
George Velmahos
Division Chief, Trauma, Emergency Surgery, Surgical Critical Care
Massachusetts General Hospital