Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
Primary Purpose
Labor Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound image guidance
Landmark palpation
Sponsored by
About this trial
This is an interventional other trial for Labor Pain
Eligibility 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
Sites / Locations
- Parkland Health Hospital System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound imaging guidance
Traditional landmark palpation
Arm Description
Determination of epidural needle site by using ultrasound guidance
Depermination of epidural needle site by using traditional landmark method
Outcomes
Primary Outcome Measures
The time needed to complete epidural placements
The number of removal and insertion of the epidural needle until feeling epidural space.
Secondary Outcome Measures
The number of needle insertion attempts
The epidural needle insertion attempts
Full Information
NCT ID
NCT04020042
First Posted
July 12, 2019
Last Updated
May 27, 2022
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04020042
Brief Title
Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Manpower issues
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound imaging guidance
Arm Type
Experimental
Arm Description
Determination of epidural needle site by using ultrasound guidance
Arm Title
Traditional landmark palpation
Arm Type
Active Comparator
Arm Description
Depermination of epidural needle site by using traditional landmark method
Intervention Type
Other
Intervention Name(s)
Ultrasound image guidance
Intervention Description
Epidural landmarks will be determined with using ultrasound image
Intervention Type
Other
Intervention Name(s)
Landmark palpation
Other Intervention Name(s)
Determination of epidural lanmakrks with palpation
Intervention Description
Epidural landmarks will be determined with palpation
Primary Outcome Measure Information:
Title
The time needed to complete epidural placements
Description
The number of removal and insertion of the epidural needle until feeling epidural space.
Time Frame
Within 10 minutes during epidural needle placement
Secondary Outcome Measure Information:
Title
The number of needle insertion attempts
Description
The epidural needle insertion attempts
Time Frame
Within 10 minutes during epidural needle placement
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema Dave, MPH
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Parkland Health Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
We'll reach out to this number within 24 hrs