Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

NCT ID: NCT04776512

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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).

Conditions

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Analgesia in Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Epidural Analgesia

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

Group Type EXPERIMENTAL

Epidural Analgesia

Intervention Type PROCEDURE

Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil

ESP Block

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

Group Type EXPERIMENTAL

ESP Block With Bupivacain

Intervention Type PROCEDURE

bilateral lumbar ESP block using 0.375% Bupivacain

Interventions

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ESP Block With Bupivacain

bilateral lumbar ESP block using 0.375% Bupivacain

Intervention Type PROCEDURE

Epidural Analgesia

Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mhamed Sami Mebazaa, Professor

Role: CONTACT

0021622252589

Ben Souissi Asma, As professor

Role: CONTACT

0021698336883

Other Identifiers

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ESP versus Epidural analgesia

Identifier Type: -

Identifier Source: org_study_id

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