Labor Pain Clinical Trial
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
Verified date | May 2022 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 74 |
Est. completion date | March 23, 2021 |
Est. primary completion date | March 23, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health Hospital System | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The number of needle insertion attempts | The epidural needle insertion attempts | Within 10 minutes during epidural needle placement |
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