Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

February 26, 2021 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural Analgesia
Patients of this group Will receive an epidural analgesia through a lumbar epidural catheter
Procedure: Epidural Analgesia
Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil
Experimental: ESP Block
Bilateral ESP block performed at the level of the 3 rd Lumbar transverse process.
Procedure: ESP Block With Bupivacain
bilateral lumbar ESP block using 0.375% Bupivacain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia during labor
Time Frame: change in VAS score 1 hour after the beginning of labor
analgesia assessed using VAScore
change in VAS score 1 hour after the beginning of labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mongi Slim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP versus Epidural analgesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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