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临床试验/CTRI/2026/02/104057
CTRI/2026/02/104057尚未招募不适用

A Study to compare the Epifaith syringe versus the conventional LOR syringe for the identification of the epidural space

未提供1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
1

研究概览

简要总结

The EpiFaith syringe is a recently developed, spring-loaded, loss of resistance (LOR) syringe that can apply different degrees of constant syringe pressure while the operator is advancing the epidural needle, which releases when the epidural space is reached. It provides objective and quantitative pressure information as well as a visual signal, which is triggered when the needle tip enters the epidural space.The study hypothesizes that the EpiFaith syringe can detect the LOR of the epidural space effectively with its achievable pressure.

 

•This is a single blind, randomized observational study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study after giving informed consent. After screening, eligible subjects will be randomly assigned to one of the following groups: Group 1: detection by EpiFaith syringe; Group 2: detection by LOR syringe. The following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 18 years and older
  • Surgery requiring epidural anesthesia or analgesia
  • ASA Physical Status 1 to 3.

排除标准

  • 未提供

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Ritu Baloda

Pt B.D.Sharma PGIMS

研究点 (1)

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