Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain assessment immediately before and after catheter placement
研究概览
简要总结
The investigators plan to compare the incidence of successful placement of epidural pain catheters versus paracostal catheters for the control of pain and prevention of pulmonary complications for adult trauma patients with blunt chest wall trauma resulting in multiple rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is being admitted to the Surgical ICU, and is encountered within 72 hours from the time of their injury, they will be eligible for the study. If they (or a proxy) choose to participate, consent will be obtained and they will randomly be assigned to receive either an epidural or paracostal catheter for pain control. The aim of the study is to determine if paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma patients. Secondarily the investigators will evaluate success and time of placement of the assigned intervention and follow the patient throughout their hospital course to compare the success of analgesia provided by each modality along with any complications and/or benefits of the two types of catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •>/= 3 rib fractures on a single side
- •Admitted to the Surgical ICU
- •Recruited within 24 hours of admission
排除标准
- •Patient allergy to local anesthetics
- •Patient refusal
- •Inability to consent for any reason
- •Prisoners
- •Age < 18
- •Pregnant women (pregnancy screen performed as part of routine trauma admission labs)
- •Absolute contraindications for either thoracic epidural or paracostal pain catheter placement which include:
- •Localized rash or skin infection over the likely site of insertion (We never want to translocate infectious material from the skin to the epidural space or even into the soft tissue where paracostal catheters lay, although for these there is more flexibility in adjusting placement)
- •Spinal/vertebral instability/fracture including any significant vertebral body injury and 3 or more spinous process fractures near the level of desired epidural placement (transverse process fractures are not considered a contraindication)
- •History of extensive back surgery at the level of desired epidural placement
- •Severe aortic stenosis, mitral stenosis, or pulmonary hypertension
- •Inability to correct coagulopathy (to International Normalized Ratio>1.5)
- •Persistent hemodynamic instability (hypotension with Systolic Blood Pressure<90 that does not respond to initial fluid boluses and requires ongoing pressors beyond the 72 hour window for enrollment)
- •Inability to cooperate and participate in placement (if intubated and sedated, for example) or to lie in the correct position for placement (lateral decubitus for paracostal pain catheters, either sitting up or lateral decubitus for epidural placement)
- •Concern for elevated intracranial pressure (we imagine these patients will also be intubated)
研究组 & 干预措施
Thoracic epidural catheter
Thoracic epidurals work by delivering local anesthetics and narcotics to the epidural space, which then diffuse into the spinal nerve roots and block the transmission of pain from the chest wall to the spinal cord and brain.
干预措施: Thoracic epidural catheter placement (Other)
Paracostal catheter
Paracostal catheters run along the outer surface of the chest wall and act by delivering local anesthetics to the intercostal nerves as traverse the lower border of the ribs.
干预措施: Paracostal catheter placement (Other)
结局指标
主要结局
Pain assessment immediately before and after catheter placement
时间窗: within an hour before and after catheter placement
Pain scores are assessed by nursing on an hourly basis in the ICU
次要结局
- Comparison of improvements in pulmonary function(Duration of admission up to 30 days as long as the patient remains in the ICU)
- Comparison of improvements in maximum daily incentive spirometry(Duration of admission up to 30 days)
- Comparison of improvements in forced vital capacity(Duration of admission up to 30 days as long as the patient remains in the ICU)
- Comparison of improvements in peak expiratory flow(Duration of admission up to 30 days as long as the patient remains in the ICU)
- successful placement of randomized intervention (paracostal vs. epidural catheter)(Within 24 hours of recruitment)
- Comparison of analgesic effect as measured by daily pain scores(Duration of admission up to 30 days)
- Number of patients in each group with pulmonary complications(Duration of admission up to 30 days)
- ICU length of stay(Duration of admission up to 30 days)
- Hospital length of stay(Duration of admission up to 30 days)
- 30-day Mortality(Duration of admission up to 30 days)
- Comparison of daily requirement for narcotics and other additional pain medications.(Duration of admission up to 30 days)
- Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)(Duration of admission up to 30 days)