N/A
N=18
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT02984267 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Total Time Required for Epidural Catheter Placement — 6.1; 11.0 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Device); Palpation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Thomas J. Vernon
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Time Required for Epidural Catheter Placement |
6.1; 11.0 | — |
| SECONDARY Epidural Procedure Time |
4.33; 10.1 | — |
| SECONDARY Number of Attempts at Epidural Catheter Placement |
1; 5 | — |
| SECONDARY Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt |
5; 2 | — |
| SECONDARY Complications |
0; 4 | — |
| SECONDARY Epidural Failure Rate |
0; 0 | — |
| SECONDARY Epidural Catheter Placement Satisfaction Level |
9; 7.3 | — |
| SECONDARY Patient Anxiety Level |
5.4; 6.0 | — |
| SECONDARY Palpation or Ultrasound Time |
1.8; 0.9 | — |
| SECONDARY Overall Anesthesia Experience Satisfaction |
79.1; 74.3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02984267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.