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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Epidural Analgesia for Labour and Delivery

Treatments

Other: Location of the epidural analgesia catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05897814
APHP230314
2023-A00076-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Parturients
Experimental group
Description:
Adult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter.
Treatment:
Other: Location of the epidural analgesia catheter

Trial contacts and locations

1

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Central trial contact

Hélène Morel; Lauranne Ossé, MD, PhD

Data sourced from clinicaltrials.gov

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