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

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Ultrasound
* Other: Palpation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Group<br>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement | Device: Ultrasound<br>* Using ultrasound guidance to evaluate the spine prior to epidural placement<br>|
| Other: Palpation Group<br>The control group that will have their epidural placed in the usual fashion based on palpation | Other: Palpation<br>* Using palpation only to evaluate the spine prior to epidural placement<br>|

What is the study measuring?
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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 |