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

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ClinicalTrials.gov Identifier: NCT01243216
Recruitment Status : Withdrawn (Lack of personnel/research time)
First Posted : November 18, 2010
Last Update Posted : September 30, 2016
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
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

Condition or disease Intervention/treatment
Pregnancy Labor Pain Device: Ultrasound

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients
Study Start Date : October 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound Group
Patients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement
Device: 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)
No Intervention: No Ultrasound Group
Patients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement.

Primary Outcome Measures :
  1. Number of attempts needed for proper needle placement [ Time Frame: 30 min or less ]
    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

Secondary Outcome Measures :
  1. Time [ Time Frame: 30 min ]
    The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia

  2. Patient Satisfaction [ Time Frame: 30 min ]
    Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243216

United States, Missouri
Women's and Children's Hospital
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Principal Investigator: Steven T Fogel, M.D. University of Missouri-Columbia School of Medicine

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01243216     History of Changes
Other Study ID Numbers: 1167437
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Epidural Analgesia
Epidural Anesthesia
Spinal Anesthesia
Neuraxial Analgesia
Neuraxial Anesthesia
Cesarean delivery

Additional relevant MeSH terms:
Labor Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs