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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-08-31

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

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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.

Conditions

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Pregnancy Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Ultrasound Group

Patients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

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)

No Ultrasound Group

Patients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound

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)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes