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临床试验/NCT02159560
NCT02159560已完成不适用

Uniport and Multiport Epidural Catheters in Post-surgical Patients

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Epidural Catheter Failure

研究概览

简要总结

The investigators hypothesize that multi-port thoracic epidural catheters will provide superior pain relief when compared to uniport catheters for post-surgical patients.

详细描述

Epidural analgesia (pain relief) is an effective treatment for post-surgical acute pain. The factors that determine the effectiveness of pain relief with epidural analgesia have been studied almost exclusively in the lumbar (low back) spaces for obstetrics (childbirth). These factors include the design of the epidural catheter, the type and dose of medications, and the volume of solution used. One of the important issues specific to the catheter design is whether the tip has a one end-hole, or multiple side holes. The number of holes has been suggested to affect the spread of epidural anesthetic over time, especially with low volume solutions. This has been demonstrated in older, stiffer epidural catheter designs, but has not been shown to be true with the newer, flexible epidural catheters.

The thoracic (upper back) epidural analgesia is widely employed for a many types of surgical pain. While the mechanism of pain relief is similar to that in the lumbar space, there may be differences between the two sites. Firstly, thoracic catheters tend to use low volume, high concentration medication solutions, which likely do not spread as effectively. Secondly, the thoracic catheters often need to be used for prolonged periods of time. Whereas the typical obstetric epidural is used for less than 12 hours, the post-surgical catheter is typically required for one to three days (or more). Finally, the thoracic space is narrow, with a thinner thecal sac, which might promote a difference in the spread of epidural solution.

Thoracic epidural analgesia is routinely used to control post-operative pain for a wide variety of surgical procedures. Based on the improved effectiveness of the one end-hole flexible epidural catheter in obstetrics, this design is commonly used in thoracic epidural analgesia. It has been observed that thoracic epidurals are somewhat less effective after a period of time when compared to the effectiveness of labor epidurals. This may be in part due to the inappropriate assumption that the thoracic epidural space of a post-surgical patient is the same as the lumbar space of a parturient.

The investigators seek to determine whether there is a difference in the analgesia provided by a thoracic multi-port epidural catheter when compared to a thoracic uniport epidural catheter as measured by pain scores, medication given for breakthrough pain, and need to add intravenous opioids. As mentioned previously, these catheters have been studied extensively in laboring patients but there is a striking paucity of literature regarding how anesthetic solutions spread in the thoracic epidural spaces of non-pregnant post-surgical patients and how this may be affected by catheter type. If the hypothesis is supported by results, it may change the practice within the study institution, and possibly, on a much larger scale. This study may also provide a foundation for further research into the physiology of the thoracic epidural space, how it differs from the lumbar epidural space, and how a medication solution spreads within this unique space.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

patient, evaluator, statistician all blinded to assignment

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Surgery in the thorax or upper abdomen
  • Age between 18 and 75
  • Expected use of epidural analgesia for >24 hours

排除标准

  • Contraindication to epidural catheterization
  • Chronic use of opioids
  • Chronic pain
  • Allergy to the standard medications used
  • Body Mass Index >40

结局指标

主要结局

Epidural Catheter Failure

时间窗: 72 hours

The primary outcome of the study will be the incidence of failed epidural analgesia, defined as the need to add intravenous opioids or halting or replacing the epidural catheter because of lack of pain control.

次要结局

  • Number of Subjects Receiving Supplemental Treatments(72 hours)

研究者

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

Phillip Hess

Chief of Obstetric Anesthesia

Beth Israel Deaconess Medical Center

研究点 (2)

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