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
About this trial
This is an interventional treatment trial for Analgesia in Labor focused on measuring analgesia, vaginal delivery, ESP, EPIDURAL
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
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
NCT ID
NCT04776512
First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Mongi Slim Hospital
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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