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

Epidural Analgesia for Labour and Delivery Clinical Trial

— ETEMERC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897814
• Other study ID #: APHP230314
• Secondary ID: 2023-A00076-39
• Status: Completed
• Phase: N/A
• Start date: September 9, 2023
• Est. completion date: May 26, 2024

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 26, 2024
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epidural Analgesia for Labour and Delivery

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

Vanhaesebrouck A, Vilain A, Rey S, Fresson J. Les maternite´s en 2016: re´sultats de l'enque^te nationale pe´rinatale (ENP). Revue d'E´pide´miologie et de Sante´ Publique. 2018;66:S54

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 0
Secondary	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.	14 months
Secondary	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.	14 months
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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	Day 0