search
Back to results

Color Doppler to Confirm Epidural Catheter Positioning in Parturient

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Color Doppler
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: obstetric patients admitted for epidural analgesia in the labor department suite (LDS) Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group (C)

    Group (O)

    Arm Description

    patients with BMI less than 35

    patients with BMI more than 35

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2022
    Last Updated
    November 4, 2022
    Sponsor
    Menoufia University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05606952
    Brief Title
    Color Doppler to Confirm Epidural Catheter Positioning in Parturient
    Official Title
    Color Doppler to Confirm Epidural Catheter Positioning in Parturient, Would it Help
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Prospective study
    Allocation
    Non-Randomized
    Enrollment
    194 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group (C)
    Arm Type
    Active Comparator
    Arm Description
    patients with BMI less than 35
    Arm Title
    Group (O)
    Arm Type
    Active Comparator
    Arm Description
    patients with BMI more than 35
    Intervention Type
    Device
    Intervention Name(s)
    Color Doppler
    Other Intervention Name(s)
    Epidural catheter
    Intervention Description
    color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
    Primary Outcome Measure Information:
    Title
    sensitivity
    Description
    Number and percentage of patients in both groups where the flow was detected
    Time Frame
    30 min

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Labour analgesia
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: obstetric patients admitted for epidural analgesia in the labor department suite (LDS) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    rabab M habeeb
    Phone
    01001970973
    Ext
    02
    Email
    rabab_habeeb@med.menofia.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Color Doppler to Confirm Epidural Catheter Positioning in Parturient

    We'll reach out to this number within 24 hrs