View Clinical Trial (Medical Research Study)
The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65201 |
| Conditions: |
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Pregnancy - Labor Pain - Cesarean Delivery |
| Purpose: |
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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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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01243216 |
| Primary Contact: |
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Principal Investigator
Steven T Fogel, M.D.
University of Missouri-Columbia School of Medicine
Steven T Fogel, M.D.
Phone: 573-882-2568
Email: fogels@health.missouri.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbia, Missouri 65201
United States
Steven T Fogel, M.D.
Phone: 573-882-2568
Email: fogels@health.missouri.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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