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临床试验/NCT06556836
NCT06556836已完成不适用

"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization in Patients Undergoing Open Abdominal Surgery"

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Diagnostic accuracy of ultrasound Mode M compared to epidurography for localizing the catheter in the epidural space.

研究概览

简要总结

The goal of this clinical trial is to evaluate the effectiveness of ultrasound for locating epidural catheters compared to the gold standard, epidurography. This study is focused on patients undergoing major open abdominal surgeries, who often experience moderate to severe pain during the first 24 to 48 hours after surgery.

The main questions it aims to answer are:

How does the accuracy of ultrasound for detecting epidural catheter placement compare to that of epidurography? Can ultrasound provide a reliable alternative to epidurography in surgical settings where epidurography is not feasible?

In this trial, participants will:

Undergo a standard epidural analgesia procedure for pain management during their surgery.

Have their epidural catheter placement checked using both ultrasound and epidurography.

Report their pain levels and any issues with pain control during the immediate postoperative period.

The study will assess whether ultrasound can effectively replace epidurography in confirming catheter placement, potentially offering a less invasive and more practical solution in routine surgical environments.

详细描述

Introduction

Major open abdominal surgeries often result in moderate to severe pain during the first 24-48 hours postoperatively. Epidural analgesia is effective in managing pain for open abdominal and thoracic surgeries during this immediate postoperative period and is considered the gold standard in accelerated rehabilitation protocols. The effectiveness of this pain relief method depends on the precise placement of the catheter in the epidural space. Since the procedure is performed blindly and relies on the anesthesiologist's skill, coupled with variations in anatomical structures, the failure rate of catheter placement ranges from 12% to 30%. Identifying catheter misplacement early in the postoperative period is challenging, as residual anesthetic effects may mask its ineffectiveness if the catheter is positioned outside the epidural space. This challenge can result in uncontrolled postoperative pain later on.

Given the inherent difficulties in catheter placement and the limitations of relying on indirect anatomical assessment and sensory cues, even experienced clinicians may find epidural catheter insertion challenging. Sensory testing and patient-reported pain scores, while useful, do not consistently offer objective confirmation of correct catheter placement. Therefore, more practical and objective methods are needed.

Ultrasound Techniques

Color Doppler ultrasound, which visualizes fluid dynamics and flow direction, and M-mode ultrasound, which provides grayscale images of movement, could offer valuable insights. When fluid is injected into a confined space like the epidural space, it is expected to create turbulence, which would appear as a burst of color on the Doppler image. This turbulence arises because the fluid encounters resistance as it moves through the narrow epidural space. Although studies have demonstrated the reliability of color Doppler ultrasound for visualizing fluid flow through a needle in the caudal space in both adults and children, this does not directly translate to assessing catheter placement in the lumbar epidural space. For example, case series by Riveros-Pérez et al. and Elsharkawy et al. reported that only 37% and 68% of epidural catheter tips were visible in the posterior complex using color Doppler, respectively. Studies have shown mixed results regarding their effectiveness, and their application to detecting catheter placement in the lumbar epidural space has yet to be fully established.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

入选标准

  • Adults aged 18 years or older
  • Provided informed consent
  • Scheduled for major open abdominal surgery that necessitates epidural analgesia
  • Capable of completing the PAIN OUT questionnaire

排除标准

  • Contraindications to epidural analgesia
  • Communication or cognitive impairments that prevent understanding or completing the questionnaire
  • Neurological disorders that affect sensory or motor function
  • Critical illness or unstable medical conditions
  • Use of anticoagulants
  • Advanced liver cirrhosis
  • Certain specific surgical procedures where epidural analgesia is contraindicated or not applicable
  • Allergy to contrast agent

结局指标

主要结局

Diagnostic accuracy of ultrasound Mode M compared to epidurography for localizing the catheter in the epidural space.

时间窗: 15 minutes

Ultrasound M-Mode: To detect a granular or undulating pattern when intermittent boluses of saline solution are administered through the epidural catheter, which indicates correct placement within the epidural space.

Diagnostic accuracy of ultrasound color Doppler compared to epidurography for localizing the catheter in the epidural space.

时间窗: 15 minutes

Ultrasound Doppler Mode: To assess whether the color mosaic between the posterior and anterior complexes is observed when saline solution is administered through the catheter, indicating correct placement within the epidural space. Epidurography: Performed by an interventional pain specialist and a radiologist, it will confirm whether the catheter is correctly positioned inside or outside the epidural space. Diagnostic Accuracy of Ultrasound: Evaluated by comparing the findings from Doppler mode and M-mode (color mosaic and granular pattern) with the results of epidurography (inside or outside the epidural space).

次要结局

  • Pain Relief Effectiveness(10 to 15 minutes)
  • Sensory Assessment Level of Abdominal Wall:(5 minutes)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Garduño López

principal investigator (MSc and MD)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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