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Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020042
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Labor Pain Other: Ultrasound image guidance Other: Landmark palpation Not Applicable

Detailed Description:

This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups.

In routine clinical setting, patients admitted to clinic and evaluated labor condition. If patient in active labor and request epidural for labor pain, the standard care team inform obstetric anesthesia epidural team by using pager. Standard of care anesthesia epidural team perform preoperative evaluation and placed the catheter.

The patients in active labor will receive labor epidural analgesia, regardless of the study participation. There is no changes epidural local anesthetic type and doses. The research intervention is only placing hand-hold ultrasound to the back of the patient and see the land mark visually before the epidural catheter placement. The remaining catheter placement is the same as the control group.

Study Procedures:

A Total of 300 eligible parturients will be randomly assigned to one of the two groups either the ultrasound imaging guidance or the traditional landmark palpation group for labor epidural needle placement. The research intervention is simply placing a hand-held ultrasound device on the back of the patient and insert the epidural needle with ultrasound image guidance.

Parturient will receive epidural catheter regardless of the study participation. In the traditional landmark method, anesthetist palpates the structure to determine the site of the initial needle insertion site. The needle will be protruded as in usual standard practice. Anesthetist may remove and insert needle again until feeling epidural space. When anesthetist determine the tip of the needle is in the epidural space, the epidural catheter will be protruded through the needle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Timely Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation in Parturients With Various Body Mass Indices (BMI): A Prospective Randomized Clinical Trial
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound imaging guidance
Determination of epidural needle site by using ultrasound guidance
Other: Ultrasound image guidance
Epidural landmarks will be determined with using ultrasound image

Active Comparator: Traditional landmark palpation
Depermination of epidural needle site by using traditional landmark method
Other: Landmark palpation
Epidural landmarks will be determined with palpation
Other Name: Determination of epidural lanmakrks with palpation




Primary Outcome Measures :
  1. The time needed to complete epidural placements [ Time Frame: Within 10 minutes during epidural needle placement ]
    The number of removal and insertion of the epidural needle until feeling epidural space.


Secondary Outcome Measures :
  1. The number of needle insertion attempts [ Time Frame: Within 10 minutes during epidural needle placement ]
    The epidural needle insertion attempts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020042


Contacts
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Contact: Michelle Eddins, MD 214/645-1060 Michelle.Eddins@UTSouthwestern.edu
Contact: Beverly Perez, DO 469/419-2966 BEVERLY.PEREZ@UTSouthwestern.edu

Locations
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United States, Texas
Parkland Health Hospital System Recruiting
Dallas, Texas, United States, 75390
Contact: Weike Tao, MD    214-759-0387    Weike.Tao@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Director: Seema Dave, MPH UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04020042    
Other Study ID Numbers: STU-2019-0571
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms