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Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
epidural needle
epidural catheter
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. healthy, term (37-42 weeks' gestation),
  2. nulliparous women with singleton
  3. patients in active labor with a cervical dilation <5cm who planned labor analgesia

Exclusion Criteria:

  1. any contraindication to neuraxial anesthesia,
  2. body mass index>50kg/m2,
  3. VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),

5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    epidural needle

    epidural catheter

    Arm Description

    the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.

    the loading dose for labor analgesia administrated via the epidural catheter.

    Outcomes

    Primary Outcome Measures

    The time to onset of labor analgesia
    Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.

    Secondary Outcome Measures

    VSA scores
    the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
    number of PCEA bolus requests
    the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
    analgesia drug ( ropivacaine) requests
    The total ropivacaine dose is recorded and is divided by the hours.

    Full Information

    First Posted
    October 22, 2022
    Last Updated
    October 22, 2022
    Sponsor
    Women's Hospital School Of Medicine Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05594771
    Brief Title
    Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
    Official Title
    Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2022 (Anticipated)
    Primary Completion Date
    June 15, 2023 (Anticipated)
    Study Completion Date
    August 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Women's Hospital School Of Medicine Zhejiang 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
    Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.
    Detailed Description
    The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique. In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.

    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
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    epidural needle
    Arm Type
    Experimental
    Arm Description
    the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.
    Arm Title
    epidural catheter
    Arm Type
    Active Comparator
    Arm Description
    the loading dose for labor analgesia administrated via the epidural catheter.
    Intervention Type
    Procedure
    Intervention Name(s)
    epidural needle
    Intervention Description
    the loading dose for labor analgesia administrated via epidural needle before the catheter insertion
    Intervention Type
    Procedure
    Intervention Name(s)
    epidural catheter
    Intervention Description
    the loading dose for labor analgesia administrated via epidural catheter
    Primary Outcome Measure Information:
    Title
    The time to onset of labor analgesia
    Description
    Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    VSA scores
    Description
    the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
    Time Frame
    8 months
    Title
    number of PCEA bolus requests
    Description
    the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
    Time Frame
    8 months
    Title
    analgesia drug ( ropivacaine) requests
    Description
    The total ropivacaine dose is recorded and is divided by the hours.
    Time Frame
    8 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: healthy, term (37-42 weeks' gestation), nulliparous women with singleton patients in active labor with a cervical dilation <5cm who planned labor analgesia Exclusion Criteria: any contraindication to neuraxial anesthesia, body mass index>50kg/m2, VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia), 5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xinzhong Chen
    Phone
    0571-87061501
    Email
    chenxinz@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaoping Chen
    Email
    5513041@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xinzhong Chen
    Organizational Affiliation
    Women's Hospital School Of Medicine Zhejiang University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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