NCT04776512

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 23, 2021

Last Update Submit

February 26, 2021

Conditions

Analgesia in Labor

Keywords

analgesia, vaginal delivery, ESP, EPIDURAL

Outcome Measures

Primary Outcomes (1)

  • Analgesia during labor

    analgesia assessed using VAScore

    change in VAS score 1 hour after the beginning of labor

Study Arms (2)

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

ESP Block With BupivacainPROCEDURE

bilateral lumbar ESP block using 0.375% Bupivacain

ESP Block
Epidural AnalgesiaPROCEDURE

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

Epidural Analgesia

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfull termed parturients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Indication to Cesarean section during labor period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Central Study Contacts

Mhamed Sami Mebazaa, Professor

CONTACT

0021622252589msmebazaa@gamil.com

Ben Souissi Asma, As professor

CONTACT

0021698336883bsouissiasma@gamil.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of anesthesia and intensive care department

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share