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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: Ultrasound; Other: Palpation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • Magee Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time Required for 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	Assessed immediately during epidural catheter placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural Procedure Time	Time required to successfully place the epidural catheter	Assessed immediately during epidural catheter placement
Number of Attempts at Epidural Catheter Placement		Assessed immediately during 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	Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.	Assessed immediately during epidural catheter placement and within 24 hours after delivery
Epidural Failure Rate	Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported	Assessed within 24 hours after delivery
Epidural Catheter Placement Satisfaction Level	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.	Assessed immediately following epidural catheter placement
Patient Anxiety Level	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.	Assessed immediately following epidural catheter placement
Palpation or Ultrasound Time	The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion	Assessed immediately prior to epidural catheter placement
Overall Anesthesia Experience Satisfaction	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.	Measured within 24 hours of delivery

Collaborators and Investigators

• Sponsor: Thomas J. Vernon
• Collaborators: West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ACTUAL): April 15, 2017
• Study Completion (ACTUAL): April 15, 2017

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (ESTIMATE): December 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: OBUS1123