Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Presumed intervertebral level of epidural catheter
研究概览
简要总结
In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.
Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.
详细描述
Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.
Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18- 80 years old patients
- •Patients undergoing thoracic surgery
- •Patients undergoing upper abdominal surgery
排除标准
- •Severe Aortic Valve stenosis
- •Active Neurologic Disease
- •Allergy to lidocaine or bupivacaine
- •Allergy to iodine-based contrast
- •Cutaneous Disorders at epidural insertion site
- •Preoperative impaired coagulation status
- •Pregnancy
研究组 & 干预措施
Thoracic epidural catheter insertion
Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery
干预措施: Fluoroscopic imaging (Procedure)
结局指标
主要结局
Presumed intervertebral level of epidural catheter
时间窗: During procedure
At the time of thoracic epidural catheter insertion
次要结局
- Radiologic confirmation of epidural catheter placement(Post procedure within one week.)
- Change in Numeric Rating Pain Score from baseline(1, 24 and 48 hrs)
研究者
Kenneth D Candido
Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center
Chicago Anesthesia Pain Specialists