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Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

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ClinicalTrials.gov Identifier: NCT04020042
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE August 28, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
The number of needle insertion attempts [ Time Frame: Within 10 minutes during epidural needle placement ]
The epidural needle insertion attempts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
Official Title  ICMJE Timely Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation in Parturients With Various Body Mass Indices (BMI): A Prospective Randomized Clinical Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Labor Pain
Intervention  ICMJE
  • Other: Ultrasound image guidance
    Epidural landmarks will be determined with using ultrasound image
  • Other: Landmark palpation
    Epidural landmarks will be determined with palpation
    Other Name: Determination of epidural lanmakrks with palpation
Study Arms  ICMJE
  • Experimental: Ultrasound imaging guidance
    Determination of epidural needle site by using ultrasound guidance
    Intervention: Other: Ultrasound image guidance
  • Active Comparator: Traditional landmark palpation
    Depermination of epidural needle site by using traditional landmark method
    Intervention: Other: Landmark palpation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Eddins, MD 214/645-1060 Michelle.Eddins@UTSouthwestern.edu
Contact: Beverly Perez, DO 469/419-2966 BEVERLY.PEREZ@UTSouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020042
Other Study ID Numbers  ICMJE STU-2019-0571
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Seema Dave, MPH UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP