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Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

NCT04020042 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-06-01

No results posted yet for this study

Summary

Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs).

A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate the time for equipment setup due to its portability and instant power-up. In addition, it provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique features may be helpful in laboring women with a particular BMI range. We aim to define the usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in various BMIs.

The primary outcome: The time needed to complete epidural placements.

Secondary outcomes:

* The number of needle insertion attempts,
* The rate of success measured by the need to replacements during the labor course for vaginal or cesarean delivery.

Conditions

  • Labor Pain

Interventions

OTHER

Ultrasound image guidance

Epidural landmarks will be determined with using ultrasound image

OTHER

Landmark palpation

Epidural landmarks will be determined with palpation

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Seema Dave, MPH · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2021-03-23
Completion
2021-03-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020042 on ClinicalTrials.gov