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Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

Primary Purpose

Dural Puncture Epidural Technique

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional epidural
Dural puncture epidural
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dural Puncture Epidural Technique

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Age (25- 55) years. Height (150 -170) cm.

Exclusion Criteria:

Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural

    Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural

    Outcomes

    Primary Outcome Measures

    Time of onset of anesthesia to T10
    Time for complete motor block
    Time for first rescue analgesia will be required during surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2021
    Last Updated
    November 13, 2021
    Sponsor
    National Research Centre, Egypt
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04921761
    Brief Title
    Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
    Official Title
    Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    There is a duplicate study registered. The trial registration and later updates will be in NCT04933500. That is the record that will be updated.
    Study Start Date
    July 1, 2021 (Actual)
    Primary Completion Date
    October 1, 2021 (Actual)
    Study Completion Date
    November 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Research Centre, Egypt
    Collaborators
    Cairo 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 study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dural Puncture Epidural Technique

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Placebo Comparator
    Arm Description
    Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional epidural
    Intervention Description
    In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dural puncture epidural
    Intervention Description
    In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.
    Primary Outcome Measure Information:
    Title
    Time of onset of anesthesia to T10
    Time Frame
    During surgery
    Title
    Time for complete motor block
    Time Frame
    During surgery
    Title
    Time for first rescue analgesia will be required during surgery
    Time Frame
    During surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age (25- 55) years. Height (150 -170) cm. Exclusion Criteria: Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.

    12. IPD Sharing Statement

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    Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

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