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临床试验/NCT03559023
NCT03559023Unknown不适用

A Factorial Trial of Ultrasound and Manometry to Improve the Success of Thoracic Epidural Placement

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
480
试验地点
2
主要终点
Successful thoracic epidural placement

研究概览

简要总结

To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle trajectory. The use of sterile manometry tubing to demonstrate a falling and oscillating fluid column has been described as a confirmatory test in the placement of lumbar epidurals. This study will determine if the efficacy of thoracic epidural placement is improved if placement is performed with the use of either US, or manometry, or both techniques combined, compared with a standard landmark-based placement technique alone.

详细描述

In a variety of thoracic and abdominal surgeries, thoracic epidural placement is associated with better pain relief, less opioid consumption, a decrease in adverse perioperative cardiac events, and improved intestinal perfusion and motility. Unfortunately, epidural catheter placement is challenging and is not always successful. The epidural space in the thoracic region is especially difficult to access due to the steep and inferior angulation of most of the spinous processes.

The vast majority of thoracic epidurals are placed using a landmark-based technique (i.e. without ultrasound guidance or fluoroscopy). In addition, a "loss of resistance" technique is typically used to confirm the needle has entered the epidural space. With a paramedian technique, the thoracic spinous processes are palpated (if possible), the needle is advanced through the skin just lateral to the spinous processes until lamina is contacted. The needle is then redirected medially based on an estimate of the location of the midline at the interlaminar space. The needle is then "walked" cephalad or caudad to blindly search for the interlaminar space. The depth to the lamina and interlaminar space are not known which introduces additional uncertainty in the mind of the operator, who must proceed with caution so as to not advance the needle too far and puncture the dural sac. It is not surprising that the landmark approach is associated with a significant number of unsuccessful attempts, long procedure times, and ineffective catheters, with the percentage of failed thoracic epidurals reported as high as 32%. In one study, the failure rate confirmed by both epidural waveform analysis and a sensory test after local anesthetic injection, the primary failure rate was found to be 23%-24%. A higher number of procedural attempts can also lead to an increased risk for complications including paresthesia, epidural hematoma, and dural puncture headaches. The high failure rate of this procedure highlights the need for more studies on ways to improve the techniques for thoracic epidural access.

Ultrasound (US) has proven to be useful in the imaging of the spine, and has also helped improve our ability to access the lumbar epidural space. Ultrasound measurement of the epidural space depth before epidural catheter placement decreased the rate of lumbar epidural catheter replacements, and reduced the number of epidural attempts when performed by first year residents compared to attempts without ultrasound guidance. In another study the use of ultrasound to identify the depth and location of the interlaminar and epidural space improved placement of labor epidurals with a lower number of block failures, a higher number of complete blockade, a higher rate of subject satisfaction, and lower VAS scores. Ultrasound has also been used to image the thoracic spine and epidural space.

The superior medial border of the thoracic transverse process aligns with the interlaminar space. This anatomical fact, combined with the ability to use ultrasound to identify the thoracic transverse processes and other bony landmarks forms the basis of this study. In the transverse plane, ultrasound can be used to identify the thoracic spinous processes and the midline. In the paramedian plane, the lamina, articular process and transverse process can be identified. In the lumbar spine, once the articular process is identified, a paramedian angulation of the ultrasound beam is used to identify an "acoustic window" between the lamina and into the spinal canal, thus identifying the interlaminar space. In the thoracic spine, because of the tight space between the lamina and overlapping of the lamina, an acoustic window is infrequently visualized and cannot be used as a reliable method to identify the interlaminar space. In contrast, both the superior border of the transverse process and the step-off between lamina can be readily identified with ultrasound. Both of these landmarks align with the interlaminar space.

In clinical practice, there is significant variability in techniques used to identify the correct epidural space. Although the loss of resistance technique is the most commonly used, variability exists in methods to confirm presence in the epidural space. Once such technique routinely used at this institution is the manometry technique. This involves using a three-way stopcock connected to clear plastic tubing IV extension tubing filled with normal saline. When the loss of resistance is detected, it can be confirmed by connecting the prefilled tubing to the Tuohy needle and opening the stopcock so the fluid inside is freely flowing. If the Tuohy needle tip is located in the epidural space, the saline column will initially fall, then exhibit pulsatility associated with heartbeat and respiration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Single (Participant)

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

入选标准

  • Epidural indicated for a T4-T10 placement site
  • American Society of Anesthesiologists (ASA) physical status I to IV

排除标准

  • Non-English speaking subjects in situations when an interpreter or consent in their native language is not available.
  • Pregnant women
  • Decsionally impaired
  • Prisoners

结局指标

主要结局

Successful thoracic epidural placement

时间窗: 15 minutes after injection of 1.5% lidocaine

Successful thoracic epidural placement as measured by diminished sensation to pinprick in two or more adjacent dermatomes 15 minutes after the injection of 5 mL of 1.5% lidocaine with 1:200,000 epinephrine into an epidural catheter.

次要结局

  • Diminished sensation to cold(15 minutes after injection of lidocaine)
  • Average pain score(First 24 hours postoperatively)
  • Complications(During epidural placement)
  • Number of attempts(During epidural placement)
  • Procedure time(During epidural placement)

研究者

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

Ryan Ivie

Principal Investigator

Oregon Health and Science University

研究点 (2)

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