Epidural Analgesia for Labour and DeliveryETEMERCNCT05897814
M-mode Ultrasonography for Epidural Catheter Identification and Confirmation of Correct Catheter Position
A study testing Location of the epidural analgesia catheter in people with Epidural Analgesia for Labour and Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Analgesia for Labour and Delivery
- What is being tested?
- Location of the epidural analgesia catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2023to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women admitted to the delivery room for a vaginal delivery with an epidural analgesia.
- Written informed consent.
- French speaking patient.
Who cannot join
- Patient with a contraindication to neuraxial analgesia.
- Visual Analogue Scale score >7 at epidural analgesia pose.
- No health insurance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Location of the epidural analgesia catheter
- Keywords
- Epidural anesthesia, Localization of the epidural analgesia catheter, Lumbar neuraxial ultrasound, Color Doppler mode, M-mode ultrasonography, Obstetric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location of the epidural analgesia catheterOther
Research of the location of the epidural analgesia catheter using M-mode and color Doppler (cD) ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Parturients | Experimental | Adult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter. Receives: Other: Location of the epidural analgesia catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (7)
Success rate of epidural catheter localisation in color Doppler (cD) ultrasonography
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.
Measured: Day 0
Risk factors associated with location failure in M-m et cD mode
Description of the risk factors associated with catheter localization failure using M-mode (M-m) and color Doppler (cD) mode.
Measured: 14 months
Best neuraxial ultrasound view to locate the epidural analgesia catheter with M-mode (M-m) and color Doppler (cD) mode
Determine the best neuraxial ultrasound view to locate the epidural catheter with M-mode (M-m) and color Doppler (cD) mode.
Measured: 14 months
Evaluate the effectiveness of epidural analgesia when the catheter is considered in the epidural space by lumbar neuraxial ultrasound
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.
Measured: Day 0
Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheter
Evaluate the time required in minutes to confirm the correct positioning of the epidural analgesia catheter using M-m and cD mode.
Measured: Day 0
Assess operator satisfaction with M-mode (M-m) and color Doppler (cD) to locate the epidural catheter
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.
Measured: Day 0
Evaluate the satisfaction of parturients in terms of comfort during the lumbar neuraxial ultrasound to identify the epidural catheter
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start9 Sep 2023
- Primary completion26 May 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epidural Analgesia for Labour and DeliveryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lauranne Ossé, Principal investigator, Assistance Publique - Hôpitaux de ParisHawa Keita-Meyer, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897814
- Sponsor's protocol ID
- APHP230314
- Other IDs
- 2023-A00076-39
- Acronym
- ETEMERC
- Status last verified
- Sep 2025
- First submitted
- 11 May 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Sicard JA, Forestier J. Radiographic method for exploration of the extradural space using lipidol. Rev Neurol. 1921;28:1264
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.
PubMed 25493689Elsharkawy 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.
PubMed 28074426Riveros-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.
PubMed 30482003Osse L, Myriam B, Dahan S, Xavier R, Saumtally H, Orliaguet G, Bouvet L, Keita H. Performance of M-mode and Color Doppler Ultrasound for Confirming Epidural Catheter Placement in Laboring women: A Prospective Cohort Study. Anaesth Crit Care Pain Med. 2026 Apr 14:101850. doi: 10.1016/j.accpm.2026.101850. Online ahead of print.
PubMed 41990952
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of M-mode Ultrasonography for Epidural Catheter Identification, and Correct Placement, in Obstetric Anesthesia
- ClinicalTrials.gov ID
- NCT05897814
- Acronym / sponsor ID
- ETEMERC / APHP230314
- Keywords
- Epidural anesthesia, Localization of the epidural analgesia catheter, Lumbar neuraxial ultrasound, Color Doppler mode, M-mode ultrasonography, Obstetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 26 May 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients | Experimental | Other: Location of the epidural analgesia catheterAdult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women admitted to the delivery room for a vaginal delivery with an epidural analgesia.
- Written informed consent.
- French speaking patient.
Key exclusion criteria (3 listed)
- Patient with a contraindication to neuraxial analgesia.
- Visual Analogue Scale score >7 at epidural analgesia pose.
- No health insurance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Location of the epidural analgesia catheterResearch of the location of the epidural analgesia catheter using M-mode and color Doppler (cD) ultrasonography. | Other | Parturients |
Primary outcome
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.
7 secondary outcomes
Success rate of epidural catheter localisation in color Doppler (cD) ultrasonography
Time frame: Day 0
Risk factors associated with location failure in M-m et cD mode
Time frame: 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
Evaluate the effectiveness of epidural analgesia when the catheter is considered in the epidural space by lumbar neuraxial ultrasound
Time frame: Day 0
Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheter
Time frame: Day 0
Assess operator satisfaction with M-mode (M-m) and color Doppler (cD) to locate 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
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- BackgroundVanhaesebrouck 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
- BackgroundSicard JA, Forestier J. Radiographic method for exploration of the extradural space using lipidol. Rev Neurol. 1921;28:1264
- Background: PubMed 25493689Perlas 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.
- Background: PubMed 28074426Elsharkawy 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.
- Background: PubMed 30482003Riveros-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.
- Results publication: PubMed 41990952Osse L, Myriam B, Dahan S, Xavier R, Saumtally H, Orliaguet G, Bouvet L, Keita H. Performance of M-mode and Color Doppler Ultrasound for Confirming Epidural Catheter Placement in Laboring women: A Prospective Cohort Study. Anaesth Crit Care Pain Med. 2026 Apr 14:101850. doi: 10.1016/j.accpm.2026.101850. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauranne Ossé principal investigator
Assistance Publique - Hôpitaux de Paris
Hawa Keita-Meyer, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Location of the epidural analgesia catheter in people with Epidural Analgesia for Labour and Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of epidural catheter localisation in M-mode (M-m) ultrasonography (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897814, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.