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
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.
- 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|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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, 2021|
|Estimated Study Completion Date :||December 1, 2021|
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
- 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.
- The number of needle insertion attempts [ Time Frame: Within 10 minutes during epidural needle placement ]The epidural needle insertion attempts
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
|Contact: Michelle Eddins, MD||214/645-1060||Michelle.Eddins@UTSouthwestern.edu|
|Contact: Beverly Perez, DO||469/419-2966||BEVERLY.PEREZ@UTSouthwestern.edu|
|United States, Texas|
|Parkland Health Hospital System||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Weike Tao, MD 214-759-0387 Weike.Tao@utsouthwestern.edu|
|Study Director:||Seema Dave, MPH||UT Southwestern Medical Center|