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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05897814
Acronym
ETEMERC
Enrollment
100
Registered
2023-06-09
Start date
2023-09-09
Completion date
2024-05-26
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Analgesia for Labour and Delivery

Keywords

Epidural anesthesia, Localization of the epidural analgesia catheter, Lumbar neuraxial ultrasound, Color Doppler mode, M-mode ultrasonography, Obstetric

Brief summary

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.

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.

Interventions

OTHERLocation of the epidural analgesia catheter

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

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of epidural catheter localisation in M-mode (M-m) ultrasonographyDay 0The 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

MeasureTime frameDescription
Risk factors associated with location failure in M-m et cD mode14 monthsDescription of the risk factors associated with catheter localization failure using M-mode (M-m) and color Doppler (cD) mode.
Best neuraxial ultrasound view to locate the epidural analgesia catheter with M-mode (M-m) and color Doppler (cD) mode14 monthsDetermine the best neuraxial ultrasound view to locate the epidural catheter with M-mode (M-m) and color Doppler (cD) mode.
Evaluate the effectiveness of epidural analgesia when the catheter is considered in the epidural space by lumbar neuraxial ultrasoundDay 0Evaluate 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.
Success rate of epidural catheter localisation in color Doppler (cD) ultrasonographyDay 0The 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.
Assess operator satisfaction with M-mode (M-m) and color Doppler (cD) to locate the epidural catheterDay 0Operator 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.
Evaluate the satisfaction of parturients in terms of comfort during the lumbar neuraxial ultrasound to identify the epidural catheterDay 0Evaluate 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
Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheterDay 0Evaluate the time required in minutes to confirm the correct positioning of the epidural analgesia catheter using M-m and cD mode.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026