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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epidural Analgesia for Labour and Delivery

Intervention / Treatment
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* Other: Location of the epidural analgesia catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parturients<br>Adult patients admitted to the delivery room of Necker-Enfants Malades hospital maternity with an epidural catheter. | Other: Location of the epidural analgesia catheter<br>* Research of the location of the epidural analgesia catheter using M-mode and color Doppler (cD) ultrasonography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural anesthesia, Localization of the epidural analgesia catheter, Lumbar neuraxial ultrasound, Color Doppler mode, M-mode ultrasonography, Obstetric