Erector Spinae Plane Block Versus Classic Epidural Analge... | NCT04776512

Studies
Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

NCT04776512

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Mar 1, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Analgesia in Labor

Interventions

ESP Block With Bupivacain
Epidural Analgesia

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Feb 26, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2021

Last Update Posted Date

Mar 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESP Block With Bupivacain	Procedure	bilateral lumbar ESP block using 0.375% Bupivacain	ESP Block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

full termed parturients

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mhamed Sami Mebazaa, Professor	Contact	0021622252589		msmebazaa@gamil.com
Ben Souissi Asma, As professor	Contact	0021698336883		bsouissiasma@gamil.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015360	Analgesia, Epidural

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided