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Clinical Trials/NCT02984267
NCT02984267
Completed
Not Applicable

Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40

Thomas J. Vernon1 site in 1 country18 target enrollmentDecember 2016
ConditionsLabor Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Thomas J. Vernon
Enrollment
18
Locations
1
Primary Endpoint
Total Time Required for Epidural Catheter Placement
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
April 15, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Thomas J. Vernon
Responsible Party
Sponsor Investigator
Principal Investigator

Thomas J. Vernon

OB Anesthesia Fellow

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Current (pregnant) BMI ≥ 40
  • ASA score of 3 or less
  • Full term pregnancy (37 weeks gestational age or greater)

Exclusion Criteria

  • Known scoliosis
  • Known contraindications to neuraxial blockade
  • Intrauterine fetal demise or non-viable fetus.

Outcomes

Primary Outcomes

Total Time Required for Epidural Catheter Placement

Time Frame: Assessed immediately during epidural catheter placement

Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter

Secondary Outcomes

  • Epidural Procedure Time(Assessed immediately during epidural catheter placement)
  • Number of Attempts at Epidural Catheter Placement(Assessed immediately during epidural catheter placement)
  • Patient Anxiety Level(Assessed immediately following epidural catheter placement)
  • Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt(Assessed immediately during epidural catheter placement)
  • Complications(Assessed immediately during epidural catheter placement and within 24 hours after delivery)
  • Epidural Failure Rate(Assessed within 24 hours after delivery)
  • Epidural Catheter Placement Satisfaction Level(Assessed immediately following epidural catheter placement)
  • Palpation or Ultrasound Time(Assessed immediately prior to epidural catheter placement)
  • Overall Anesthesia Experience Satisfaction(Measured within 24 hours of delivery)

Study Sites (1)

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