Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

Not Applicable

• Conditions: Analgesia in Labor
• Interventions: Procedure: ESP Block With Bupivacain; Procedure: Epidural Analgesia

• Registration Number: NCT04776512
• Lead Sponsor: Mongi Slim Hospital

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).

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study Start: 2021-03-01
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• Indication to Cesarean section during labor period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	ESP Block With Bupivacain	Bilateral ESP block performed at the level of the 3 rd Lumbar transverse process.
Epidural Analgesia	Epidural Analgesia	Patients of this group Will receive an epidural analgesia through a lumbar epidural catheter

Primary Outcome Measures

Name	Time	Method
Analgesia during labor	change in VAS score 1 hour after the beginning of labor	analgesia assessed using VAScore