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Completed

NCT Number: NCT05897814

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Location of the epidural analgesia catheter

Other

Research of the location of the epidural analgesia catheter using M-mode and color Doppler (cD) ultrasonography.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ETEMERC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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