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OpenTrials
Completed

NCT Number: NCT02984267

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

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

Using ultrasound guidance to evaluate the spine prior to epidural placement

Palpation

Other

Using palpation only to evaluate the spine prior to epidural placement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thomas J. Vernon

Other

Collaborators

  • West Penn Allegheny Health System

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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