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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126745
• Other study ID #: 21-07
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: July 2022
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• color flow Doppler ultrasonography
Doppler ultrasonography

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound	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).	15 min
Secondary	Level of epidural catheter insertion: questionnaire	The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4	5 min
Secondary	Epidural regimen: questionnaire	Settings for the epidural pump as charted by the anesthesiologist and the nurse.	5 min
Secondary	Maximum upper sensory block to ice: questionnaire	Maximum upper sensory block to ice as charted by the nurse in the electronic charting system	5 min
Secondary	Any anesthetic intervention for patchy or asymmetric block	The anesthetic record will be reviewed for any interventions done.	5 min
Secondary	Number of manual epidural top ups	The number of top ups given by nurses or physicians manually will be recorded from the chart.	5 min
Secondary	Number of PCEA (patient controlled epidural analgesia) boluses delivered	Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.	5 min
Secondary	Duration of epidural analgesia	Time of epidural placement to delivery or placement to top up for caesarean delivery.	5 min
Secondary	Quality of analgesia questionnaire - 1st stage	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?	5 min
Secondary	Quality of analgesia questionnaire - 2nd stage	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?	5 min