M-mode Ultrasonography for Epidural Catheter Identification and Confirmation of Correct Catheter Position (ETEMERC)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of M-mode Ultrasonography for Epidural Catheter Identification, and Correct Placement, in Obstetric Anesthesia

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of M-mode (M-m) and color Doppler (cD) ultrasonography to identify the epidural catheter position for parturients in the delivery room.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

Indeed, only 2 retrospective studies have described this strategy on cohorts with small numbers of adult patients. One demonstrated in a mixed population the possible localization of the epidural analgesia catheter using color Doppler (cD) mode (67.5% of cases) and M-mode (M-m) ultrasonography (M-m) (75%). Only one study identified the position of the epidural catheter in the obstetric context due to the cD mode ; with a low rate of visualization (37.1% of cases).

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of the M-m and cD mode to identify proper catheter placement in parturients in the delivery room.

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women admitted to the delivery room for a vaginal delivery with an epidural analgesia.
  • Written informed consent.
  • French speaking patient.

Exclusion Criteria:

  • Patient with a contraindication to neuraxial analgesia.
  • Visual Analogue Scale score >7 at epidural analgesia pose.
  • No health insurance.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parturients
Adult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter.
Other: Location of the epidural analgesia catheter
Research of the location of the epidural analgesia catheter using M-mode and color Doppler (cD) ultrasonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of epidural catheter localisation in M-mode (M-m) ultrasonography
Time Frame: Day 0
The location of the epidural catheter is based on the visualization of the "beach and sea" sign with injection of the analgesic solution through the epidural catheter into the epidural space.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of epidural catheter localisation in color Doppler (cD) ultrasonography
Time Frame: Day 0
The localization of the epidural catheter is based on the visualization of a blue and red mosaic with the injection of the analgesic solution through the epidural catheter in the epidural space.
Day 0
Risk factors associated with location failure in M-m et cD mode
Time Frame: 14 months
Description of the risk factors associated with catheter localization failure using M-mode (M-m) and color Doppler (cD) mode.
14 months
Best neuraxial ultrasound view to locate the epidural analgesia catheter with M-mode (M-m) and color Doppler (cD) mode
Time Frame: 14 months
Determine the best neuraxial ultrasound view to locate the epidural catheter with M-mode (M-m) and color Doppler (cD) mode.
14 months
Evaluate the effectiveness of epidural analgesia when the catheter is considered in the epidural space by lumbar neuraxial ultrasound
Time Frame: Day 0

Evaluate the percentage of epidurals having had a symmetrical sensory level > D10 when the epidural catheter is considered in the epidural space by lumbar neuraxial ultrasound.

The epidural analgesia rate with a sensory level >D10 is determined 30 min after epidural analgesia application thanks to a sensitive test.
Day 0
Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheter
Time Frame: Day 0
Evaluate the time required in minutes to confirm the correct positioning of the epidural analgesia catheter using M-m and cD mode.
Day 0
Assess operator satisfaction with M-mode (M-m) and color Doppler (cD) to locate the epidural catheter
Time Frame: Day 0
Operator satisfaction score with M-mode (M-m) and color Doppler (cD) to locate the epidural analgesia catheter with a numerical scale from 0 to 10.
Day 0
Evaluate the satisfaction of parturients in terms of comfort during the lumbar neuraxial ultrasound to identify the epidural catheter
Time Frame: Day 0
Evaluate the satisfaction of parturients in terms of comfort during the lumbar neuraxial ultrasound to identify the epidural catheter with a numerical scale from 0 to 10
Day 0

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Investigators

  • Study Director: Hawa Keita-Meyer, MD, PhD, Assistance Publique - Hopitaux de Paris
  • Principal Investigator: Lauranne Ossé, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 9, 2023

Primary Completion (Actual)

May 26, 2024

Study Completion (Actual)

May 26, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP230314
  • 2023-A00076-39 (Other Identifier: IDRCB Number)

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Epidural Analgesia for Labour and Delivery

Clinical Trials on Location of the epidural analgesia catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe