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

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05126745
Collaborator
(none)
45
1
6.6
6.8

Study Details

Study Description

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 Phase
  • Device: color flow Doppler ultrasonography

Study Design

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 :
Nov 17, 2021
Actual Primary Completion Date :
Jun 6, 2022
Actual Study Completion Date :
Jun 6, 2022

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound [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 [5 min]

    The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4

  2. Epidural regimen: questionnaire [5 min]

    Settings for the epidural pump as charted by the anesthesiologist and the nurse.

  3. Maximum upper sensory block to ice: questionnaire [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 [5 min]

    The anesthetic record will be reviewed for any interventions done.

  5. Number of manual epidural top ups [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 [5 min]

    Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.

  7. Duration of epidural analgesia [5 min]

    Time of epidural placement to delivery or placement to top up for caesarean delivery.

  8. Quality of analgesia questionnaire - 1st stage [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 [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

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
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

Locations

Site City State Country Postal Code
1 Mount Sinai Hospital Toronto Ontario Canada M5G1X5

Sponsors and Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

  • Principal Investigator: Jose CA Carvalho, MD, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT05126745
Other Study ID Numbers:
  • 21-07
First Posted:
Nov 19, 2021
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022