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

Not Applicable

Completed

Conditions: Labor Pain

Interventions: Device: Ultrasound
Other: Palpation

Registration Number: NCT02984267

Lead Sponsor: Thomas J. Vernon

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 18

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Group	Ultrasound	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Palpation Group	Palpation	The control group that will have their epidural placed in the usual fashion based on palpation

Primary Outcome Measures

Name	Time	Method
Total Time Required for Epidural Catheter Placement	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

Name	Time	Method
Epidural Procedure Time	Assessed immediately during epidural catheter placement	Time required to successfully place the epidural catheter
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	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.
Epidural Failure Rate	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
Epidural Catheter Placement Satisfaction Level	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.
Patient Anxiety Level	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.
Palpation or Ultrasound Time	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
Overall Anesthesia Experience Satisfaction	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.