Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

NCT04020042 | Terminated

• 1 other identifier: STU-2019-0571
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The time needed to complete epidural placements

  The number of removal and insertion of the epidural needle until feeling epidural space.

  Within 10 minutes during epidural needle placement

Secondary Outcomes (1)

• The number of needle insertion attempts

  Within 10 minutes during epidural needle placement

Study Arms (2)

Ultrasound imaging guidance

EXPERIMENTAL

Determination of epidural needle site by using ultrasound guidance

Other: Ultrasound image guidance

Traditional landmark palpation

ACTIVE COMPARATOR

Depermination of epidural needle site by using traditional landmark method

Other: Landmark palpation

Interventions

Ultrasound image guidance OTHER

Epidural landmarks will be determined with using ultrasound image

Ultrasound imaging guidance

Landmark palpation OTHER

Epidural landmarks will be determined with palpation

Also known as: Determination of epidural lanmakrks with palpation

Traditional landmark palpation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years
• Parturient in active labor and desires labor epidural for pain relief.
• American Society of Anesthesiologists (ASA) Class I, 2 and 3 parturients, which include normal parturients
• Parturients with morbidities (including obesity) that are not life-threatening,
• Parturient BMI ≥ 25

You may not qualify if:

• History of scoliosis or back surgery
• Patient refusal
• Patient with elevated intracranial pressure
• Any patient with a contraindication for placement of epidural anesthesia, including infection at needle insertion site, or coagulopathy.
• ASA Class 4

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Seema Dave, MPH

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 15, 2019
• Study Start: August 28, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

US (1)