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

NCT05126745 | Completed

• 1 other identifier: 21-07
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

epidural catheter; epidural analgesia; labor epidural; ultrasound; Doppler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Level of epidural catheter insertion: questionnaire

  5 min

• Epidural regimen: questionnaire

  5 min

• Maximum upper sensory block to ice: questionnaire

  5 min

• Any anesthetic intervention for patchy or asymmetric block

  5 min

• Number of manual epidural top ups

  5 min

Study Arms (1)

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

Interventions

color flow Doppler ultrasonography DEVICE

Doppler ultrasonography

Patients who had an epidural placed for labour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Women who experience fetal or maternal complications during delivery

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• van den Bosch OFC, Gleicher Y, Arzola C, Siddiqui N, Downey K, Carvalho JCA. Color flow Doppler in spinal ultrasound: a novel technique for assessment of catheter position in labor epidurals. Reg Anesth Pain Med. 2022 Dec;47(12):775-779. doi: 10.1136/rapm-2022-103948. Epub 2022 Sep 7.

  PMID: 36215115 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 19, 2021
• Study Start: November 17, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)