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NCT Number: NCT05126745

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

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

color flow Doppler ultrasonography

Device

Doppler ultrasonography

Primary outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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