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Intrathecal Analgesia for Normal Labour

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bupivacaine-fentanyl
levobupivacaine-fentanyl
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. singleton pregnancies
  2. vertex presentation who will be in the active phase of labour with a cervical dilatation >4cm
  3. normal fetal heart rate.

Exclusion Criteria:

  • 1-Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia.
  • 3 Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
    Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.

    Secondary Outcome Measures

    Analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
    Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.

    Full Information

    First Posted
    October 14, 2019
    Last Updated
    January 7, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04221568
    Brief Title
    Intrathecal Analgesia for Normal Labour
    Official Title
    The Comparison of Intrathecal Bupivacaine With Fentanyl and Levobupivacaine With Fentanyl for Labour Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    March 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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
    Primary outcome: Compare the duration of analgesia. Secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
    Detailed Description
    The pain of childbirth is the most severe pain any women can endure in their life time. Painful uterine contractions lead to maternal hyperventilation and increased catecholamine concentrations resulting im maternal and fetal hypoxemia. Labour pain when unrelieved can have adverse effect on the course of labour as well as on the fetal wellbeing. An effective labour analgesia lead to better fetal and maternal outcome. Although the gold standard in labour analgesia is utilization of epidural services which are widely used to provide pain-free labour in many parts of the world and and have the advantage of providing flexibility to meet the needs of each patient . Epidurals have long been associated with increased oxytocin use, increased fetal malposition, increased rates of instrumental and cesarian delivery, and longer labour . The use of single-shot intrathecal low dose found to be effective . The advantages of this form of technique include the rapidity of onset and reliability, with minimal hemodynamic changes and motor block. Spinal block is cheaper as well as less technically challenging when compared to epidural and combined spinal epidural block. Intrathecal analgesia alone is useful when duration of labour can be reasonably estimated. Opioid combined with a small dose of local anesthetic provides rapid analgesia and dissipates when no longer needed. Bupivacaine because of its least placental transfer, due to high protein binding and minimal motor block compared to sensory block in lower doses, has become the popular choice for labor analgesia. Addition of neuraxial lipid soluble opioids permitted reduction in the dose while maintaining effective analgesia and minimizing potential adverse effects on the progress of labor and lower extremity motor block . Levobupivacaine is the S (-) enantiomer of racemic bupivacaine. Previous studies have shown that it exhibits a clinical profile similar to bupivacaine with the added advantage of less motor impairment .

    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
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    multiparous parturients at term pregnancy (American society of anathesiologist physical status grade II)
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine-fentanyl
    Intervention Description
    local anathetic&analgesic drugs
    Intervention Type
    Drug
    Intervention Name(s)
    levobupivacaine-fentanyl
    Intervention Description
    local anathetic&analgesic drugs
    Primary Outcome Measure Information:
    Title
    Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
    Description
    Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.
    Time Frame
    From2 to 8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)
    Secondary Outcome Measure Information:
    Title
    Analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
    Description
    Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.
    Time Frame
    From2-8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: singleton pregnancies vertex presentation who will be in the active phase of labour with a cervical dilatation >4cm normal fetal heart rate. Exclusion Criteria: 1-Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia. 3 Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    peter elesha
    Phone
    +201207674699
    Email
    peter_hero14@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hamdy abbas
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    wesam nashat
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1077683
    Citation
    Brose D. [Pathology of the orofacial systems]. Zahntechnik (Berl). 1975 May;16(5):224-7. No abstract available. German.
    Results Reference
    background

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    Intrathecal Analgesia for Normal Labour

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