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

NCT05897814 | Completed

• 2 other identifiers: APHP2303142023-A00076-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Success rate of epidural catheter localisation in M-mode (M-m) ultrasonography

  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 Outcomes (7)

• Success rate of epidural catheter localisation in color Doppler (cD) ultrasonography

  Day 0

• Risk factors associated with location failure in M-m et cD mode

  14 months

• Best neuraxial ultrasound view to locate the epidural analgesia 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

  Day 0

• Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheter

  Day 0

Study Arms (1)

Parturients

EXPERIMENTAL

Adult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter.

Other: Location of the epidural analgesia catheter

Interventions

Location of the epidural analgesia catheter OTHER

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

Parturients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (5)

• Vanhaesebrouck A, Vilain A, Rey S, Fresson J. Les maternités en 2016: résultats de l'enquête nationale périnatale (ENP). Revue d'Épidémiologie et de Santé Publique. 2018;66:S54

  BACKGROUND

• Sicard JA, Forestier J. Radiographic method for exploration of the extradural space using lipidol. Rev Neurol. 1921;28:1264

  BACKGROUND

• Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184.

  PMID: 25493689 BACKGROUND

• Elsharkawy H, Sonny A, Govindarajan SR, Chan V. Use of colour Doppler and M-mode ultrasonography to confirm the location of an epidural catheter - a retrospective case series. Can J Anaesth. 2017 May;64(5):489-496. doi: 10.1007/s12630-017-0819-y. Epub 2017 Jan 10.

  PMID: 28074426 BACKGROUND

• Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.

  PMID: 30482003 BACKGROUND

Study Officials

• Lauranne Ossé

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Hawa Keita-Meyer, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 9, 2023
• Study Start: September 9, 2023
• Primary Completion: May 26, 2024
• Study Completion: May 26, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)