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Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

Primary Purpose

Analgesia in Labor

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESP Block With Bupivacain
Epidural Analgesia
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia in Labor focused on measuring analgesia, vaginal delivery, ESP, EPIDURAL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Full termed parturients admitted for vaginal delivery
  • singleton pregnancy
  • No contraindications to perimedullar analgesia techniques

Exclusion Criteria:

  • Indication to Cesarean section during labor period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Epidural Analgesia

    ESP Block

    Arm Description

    Patients of this group Will receive an epidural analgesia through a lumbar epidural catheter

    Bilateral ESP block performed at the level of the 3 rd Lumbar transverse process.

    Outcomes

    Primary Outcome Measures

    Analgesia during labor
    analgesia assessed using VAScore

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2021
    Last Updated
    February 26, 2021
    Sponsor
    Mongi Slim Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04776512
    Brief Title
    Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
    Official Title
    Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mongi Slim Hospital

    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
    Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery. At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups: ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process. Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.
    Detailed Description
    Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery. At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups: ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process. Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia. For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision. Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space. For the 2 groups, analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia in Labor
    Keywords
    analgesia, vaginal delivery, ESP, EPIDURAL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Epidural Analgesia
    Arm Type
    Experimental
    Arm Description
    Patients of this group Will receive an epidural analgesia through a lumbar epidural catheter
    Arm Title
    ESP Block
    Arm Type
    Experimental
    Arm Description
    Bilateral ESP block performed at the level of the 3 rd Lumbar transverse process.
    Intervention Type
    Procedure
    Intervention Name(s)
    ESP Block With Bupivacain
    Intervention Description
    bilateral lumbar ESP block using 0.375% Bupivacain
    Intervention Type
    Procedure
    Intervention Name(s)
    Epidural Analgesia
    Intervention Description
    Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil
    Primary Outcome Measure Information:
    Title
    Analgesia during labor
    Description
    analgesia assessed using VAScore
    Time Frame
    change in VAS score 1 hour after the beginning of labor

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    full termed parturients
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Full termed parturients admitted for vaginal delivery singleton pregnancy No contraindications to perimedullar analgesia techniques Exclusion Criteria: Indication to Cesarean section during labor period
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mhamed Sami Mebazaa, Professor
    Phone
    0021622252589
    Email
    msmebazaa@gamil.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ben Souissi Asma, As professor
    Phone
    0021698336883
    Email
    bsouissiasma@gamil.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

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