Does Ultrasound of the Spine Improve Labor Epidurals/Spinal Anesthesia in Obstetric Patients?

Study Overview
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Brief Summary
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The investigators are interested in determining the utility of ultrasound of the spine for labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The investigators hypothesized that in women with poor spinal landmarks that the use of ultrasound of the spine will improve the process of placing labor epidurals or spinal anesthetics

Detailed Description
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Ultrasound has been in use for peripheral regional anesthesia for several years and is becoming more common. It is currently routinely used here at the University of Missouri. Ultrasound for neuraxial anesthesia, however, is less common and is only being done in a few centers.. There have been several case reports of its use in obstetric anesthesia for patients with prior spinal surgery or spinal deformity. There have been even few prospective randomized studies. While its use may have significant advantages, it is not yet clear what those advantages are and in whom it may be most beneficial. The investigators seek to answer the following questions regarding the use of preprocedure ultrasound for neuraxial analgesia/anesthesia in obstetric patients: Are there benefits to the use of pre procedure ultrasound for neuraxial analgesia/anesthesia? If so, what are the benefits? If measurable, to what extent does the patient benefit? Do all patients benefit or only a specific subgroup? Is there a cost to the use of pre procedure ultrasound, i.e. extra time needed to perform the ultrasound exam vs a savings with the use of pre procedure ultrasound, i.e., less time to perform the epidural analgesic or spinal anesthetic as a direct result of the use of ultrasound? In particular the investigators hypothesize that in patients whose spinal landmarks are not palpable or are barely palpable, ultrasound will be found to be beneficial as determined by metrics described below (see item #6). In patients whose landmarks are prominent or easily palpable pre procedure ultrasound will not be of significant benefit.

Official Title
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The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients

Conditions
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Pregnancy, Labor Pain

Intervention / Treatment
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* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in labor Women scheduled for cesarean delivery Exclusion Criteria: Under age 18 Emergency cesarean deliveries Unable to cooperate with ultrasound examination or regional anesthesia Advanced labor Contraindications to regional anesthesia Unable to understand the consent process

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Group<br>Patients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement | Device: Ultrasound<br>* Ultrasound examination of the lumbar spine. The level of the lumbar interspace will be determined by the oblique/sagittal method. The transverse method will be used to determine the best lumbar interspace and the distance from the skin to the target (epidural space or intrathecal space)<br>|
| No Intervention: No Ultrasound Group<br>Patients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts needed for proper needle placement | An attempt is defined as a separate needle puncture. A needle pass is defined as the passage of a needle through a single puncture site | 30 min or less | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia | 30 min | 
| Patient Satisfaction | Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Labor, Epidural Analgesia, Epidural Anesthesia, Spinal Anesthesia, Ultrasound, Neuraxial Analgesia, Neuraxial Anesthesia, Cesarean delivery