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临床试验/NCT05606952
NCT05606952已完成不适用

Diagnostic Performance of Colour Flow Doppler for Visualization of Epidural Injectate Flow in Labouring Women: A Prospective Observational Study

Menoufia University2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
2
主要终点
sensitivity

研究概览

简要总结

The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

详细描述

patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

研究设计

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

盲法说明

Prospective study

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

排除标准

  • Patients suffering from coagulopathy.
  • Patients on recent anticoagulant therapy.
  • Patients suffering from sepsis or with local sepsis at the insertion site.
  • Patients with platelet count less than 100,000/dl.
  • Patient refusal.
  • Patient with known allergy to local anesthetic drugs
  • Patients delivered by forceps.
  • Patients who have undergone a cesarean section delivery.

研究组 & 干预措施

Group (C)

Active Comparator

patients with BMI less than 35

干预措施: Color Doppler (Device)

Group (O)

Active Comparator

patients with BMI more than 35

干预措施: Color Doppler (Device)

结局指标

主要结局

sensitivity

时间窗: 30 min

Number and percentage of patients in both groups where the flow was detected

次要结局

未报告次要终点

研究者

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

rabab Mohammad habeeb

Principal investigator

Menoufia University

研究点 (2)

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