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Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals

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ClinicalTrials.gov Identifier: NCT05126745
Recruitment Status : Completed
First Posted : November 19, 2021
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study Description
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Brief Summary:

Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.

The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.


Condition or disease Intervention/treatment
Labor Pain Device: color flow Doppler ultrasonography

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Actual Study Start Date : November 17, 2021
Actual Primary Completion Date : June 6, 2022
Actual Study Completion Date : June 6, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients who had an epidural placed for labour
Patients who had an epidural placed for labour may take part. Study procedures will take place after delivery and prior to removal of the epidural catheter.
 Device: color flow Doppler ultrasonography
Doppler ultrasonography


Outcome Measures
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Primary Outcome Measures :
  1. Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound [ Time Frame: 15 min ]
    Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).


Secondary Outcome Measures :
  1. Level of epidural catheter insertion: questionnaire [ Time Frame: 5 min ]
    The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4

  2. Epidural regimen: questionnaire [ Time Frame: 5 min ]
    Settings for the epidural pump as charted by the anesthesiologist and the nurse.

  3. Maximum upper sensory block to ice: questionnaire [ Time Frame: 5 min ]
    Maximum upper sensory block to ice as charted by the nurse in the electronic charting system

  4. Any anesthetic intervention for patchy or asymmetric block [ Time Frame: 5 min ]
    The anesthetic record will be reviewed for any interventions done.

  5. Number of manual epidural top ups [ Time Frame: 5 min ]
    The number of top ups given by nurses or physicians manually will be recorded from the chart.

  6. Number of PCEA (patient controlled epidural analgesia) boluses delivered [ Time Frame: 5 min ]
    Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.

  7. Duration of epidural analgesia [ Time Frame: 5 min ]
    Time of epidural placement to delivery or placement to top up for caesarean delivery.

  8. Quality of analgesia questionnaire - 1st stage [ Time Frame: 5 min ]

    Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 :

    On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated?


  9. Quality of analgesia questionnaire - 2nd stage [ Time Frame: 5 min ]

    Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10:

    On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby?



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women who have delivered under epidural analgesia, either with vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
Criteria

Inclusion Criteria:

  • Women who have delivered under epidural analgesia
  • Women who have vaginal or caesarean delivery
  • Women with the epidural catheter still in place

Exclusion Criteria:

-Women who experience fetal or maternal complications during delivery

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126745


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT05126745    
Other Study ID Numbers: 21-07
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
epidural catheter
epidural analgesia
labor epidural
ultrasound
Doppler
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations