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Comparison of the Epifaith® Syringe With the Plastic Syringe

Primary Purpose

Epidural; Anesthesia, Headache, Analgesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labor analgesia
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural; Anesthesia, Headache

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: ASA II to III Require labor analgesia Has submitted inform consent Exclusion Criteria: ASA IV or above Coagulopathy Spinal deformity Neurological, psychological, cardiopulmonary disorder Active liver or kidney injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    The Epifaith® syringe

    The plastic syringe

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time consumed to identify the epidural space
    Starting on the moment which the syringe be attached to the needle

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06085027
    Brief Title
    Comparison of the Epifaith® Syringe With the Plastic Syringe
    Official Title
    Compare the Epifaith® Syringe With the Plastic Syringe for Identification of the Epidural Space in Parturients: A Prospective Randomized Control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are: Whether it consume less time identifying epidural space with the Epifaith® syringe Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epidural; Anesthesia, Headache, Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Epifaith® syringe
    Arm Type
    Experimental
    Arm Title
    The plastic syringe
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Labor analgesia
    Intervention Description
    Perform epidrual analgesia for parturients between 18 to 45 year-old
    Primary Outcome Measure Information:
    Title
    Time consumed to identify the epidural space
    Description
    Starting on the moment which the syringe be attached to the needle
    Time Frame
    During the procedure

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ASA II to III Require labor analgesia Has submitted inform consent Exclusion Criteria: ASA IV or above Coagulopathy Spinal deformity Neurological, psychological, cardiopulmonary disorder Active liver or kidney injury
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sheng Yang, MD
    Phone
    +886978989351
    Email
    chubbyming20@cgmh.org.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rou-Yan Lin, MD
    Phone
    +886978989198
    Email
    emily920703@cgmh.org.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Epifaith® Syringe With the Plastic Syringe

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