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

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ClinicalTrials.gov Identifier: NCT02984267
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by (Responsible Party):
Thomas J. Vernon, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Labor Pain Device: Ultrasound Other: Palpation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Study Start Date : December 2016
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : April 15, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound Group
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
 Device: Ultrasound
Using ultrasound guidance to evaluate the spine prior to epidural placement
Palpation Group
The control group that will have their epidural placed in the usual fashion based on palpation
 Other: Palpation
Using palpation only to evaluate the spine prior to epidural placement


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Epidural Procedure Time [ Time Frame: Assessed immediately during epidural catheter placement ]
    Time required to successfully place the epidural catheter

  2. Number of Attempts at Epidural Catheter Placement [ Time Frame: Assessed immediately during epidural catheter placement ]
  3. Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt [ Time Frame: Assessed immediately during epidural catheter placement ]
  4. Complications [ Time Frame: Assessed immediately during epidural catheter placement and within 24 hours after delivery ]
    Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.

  5. Epidural Failure Rate [ Time Frame: Assessed within 24 hours after delivery ]
    Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported

  6. Epidural Catheter Placement Satisfaction Level [ Time Frame: Assessed immediately following epidural catheter placement ]
    Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.

  7. Patient Anxiety Level [ Time Frame: Assessed immediately following epidural catheter placement ]
    Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.

  8. Palpation or Ultrasound Time [ Time Frame: Assessed immediately prior to epidural catheter placement ]
    The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion

  9. Overall Anesthesia Experience Satisfaction [ Time Frame: Measured within 24 hours of delivery ]
    Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current (pregnant) BMI ≥ 40
  • Age ≥ 18
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02984267


Locations
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United States, Pennsylvania
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Thomas J. Vernon
West Penn Allegheny Health System
  Study Documents (Full-Text)

Documents provided by Thomas J. Vernon, University of Pittsburgh:
Statistical Analysis Plan  [PDF] October 1, 2016
Study Protocol  [PDF] October 1, 2016

More Information
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Responsible Party: Thomas J. Vernon, OB Anesthesia Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02984267    
Other Study ID Numbers: OBUS1123
First Posted: December 6, 2016    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations