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

NCT ID: NCT05126745

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-06-06

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

color flow Doppler ultrasonography

Intervention Type: DEVICE

Doppler ultrasonography

Interventions

color flow Doppler ultrasonography

Doppler ultrasonography

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36215115 (View on PubMed)

Other Identifiers

21-07

Identifier Type: -

Identifier Source: org_study_id