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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05126745
Enrollment
45
Registered
2021-11-19
Start date
2021-11-17
Completion date
2022-06-06
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

epidural catheter, epidural analgesia, labor epidural, ultrasound, Doppler

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.

Interventions

DEVICEcolor flow Doppler ultrasonography

Doppler ultrasonography

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound15 minVisualization 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

MeasureTime frameDescription
Epidural regimen: questionnaire5 minSettings for the epidural pump as charted by the anesthesiologist and the nurse.
Maximum upper sensory block to ice: questionnaire5 minMaximum upper sensory block to ice as charted by the nurse in the electronic charting system
Any anesthetic intervention for patchy or asymmetric block5 minThe anesthetic record will be reviewed for any interventions done.
Number of manual epidural top ups5 minThe number of top ups given by nurses or physicians manually will be recorded from the chart.
Level of epidural catheter insertion: questionnaire5 minThe anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
Duration of epidural analgesia5 minTime of epidural placement to delivery or placement to top up for caesarean delivery.
Quality of analgesia questionnaire - 1st stage5 minQuality 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?
Quality of analgesia questionnaire - 2nd stage5 minQuality 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?
Number of PCEA (patient controlled epidural analgesia) boluses delivered5 minNumber of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026