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临床试验/NCT06019039
NCT06019039已完成不适用

The Role of Power Doppler Ultrasonography in Localization of Epidural Catheter : an Observational Prospective Study

Yasser S Mostafa, MD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visualization of flow relative to the interspace insertion level by color flow Doppler

研究概览

简要总结

Epidural anesthesia is a widely used method for pain relief which is useful in various settings. Identification of needle entry into the epidural space (EDS) is performed most using a loss of resistance (LOR) technique, which was described in 1921 by Sicard and Forestier, and has remained largely unchanged since. Hysterectomy operations anesthesia and analgesia rely heavily on proper needle placement technique. A noninvasive approach to confirm the correct position of the epidural needle prior to injection of local anesthetics into the epidural space, would thus be beneficial. Ultrasound (US) is a noninvasive approach increasingly used in anesthesia practice. The use of color flow Doppler (CFD) may further aid in defining the epidural space. The aim of current study is to detect and confirm site of epidural catheter in hysterectomy by using color flow doppler ultrasonography.

详细描述

This study will be performed in the Fayoum University hospital. The study design will be prospective study. A detailed informed consent will be signed by the eligible patients .

female patients who undergoing an ultrasound guided for hysterectomy will be included in this review. The ultrasound guided epidural will be used in those in which an anticipated technical difficult landmark epidural space localization will be expected. These included those patients with diagnosis of obesity, defined as Body Mass Index (BMI) ≥35 kg/m2, and lumbar scoliosis, as well as those with poorly defined surface lumbar bone anatomy.

Demographic data, intervertebral level of insertion, dermatome level, and failure rate of epidural needle placement using CFD will be noted for each patient. Operation will be obtained via spinal epidural technique.

Sterile preparation and dropping of the area will be followed by placement of a curvilinear ultrasound transducer in a sterile sheath. The ultrasound will be used to identify the interspinous space. The epidural needle will be guided with the use of ultrasound direction by the use of an out of plane technique.

A two-hand technique will be used to manipulate the needle and ultrasound probe.

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
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who will have hysterectomy operation under epidural analgesia
  • Women with the epidural catheter still in place
  • American Society of Anesthesiologists (ASA) physical status I, II
  • Age range from 30 and 70 years.

排除标准

  • Patient refusal
  • History of allergy to one of the study drugs.
  • Any contraindication to regional anesthesia such as local infection or bleeding disorders

研究组 & 干预措施

Epidural Ultrasound group

After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter.

干预措施: Normal Saline Flush (Drug)

Epidural Ultrasound group

After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter.

干预措施: Doppler (Device)

结局指标

主要结局

Visualization of flow relative to the interspace insertion level by color flow Doppler

时间窗: 1 minute after insertion of epidural catheter

Yes or no

次要结局

  • Duration of epidural analgesia(First 24 hours postoperatively.)
  • Maximum upper sensory block to ice as charted by the nurse(15 minutes after insertion of epidural catheter)
  • Level of epidural catheter insertion(1 minute after insertion of epidural catheter)
  • Verbal numerical rating scale(8 hours postoperatively)
  • Incidence of patchy or asymmetric block(15 minutes after insertion of epidural catheter)
  • Intervertebral level at which the epidural catheter is inserted(1 minute after insertion of epidural catheter)

研究者

发起方
Yasser S Mostafa, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasser S Mostafa, MD

Lecturer of anesthesia

Fayoum University Hospital

研究点 (1)

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