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

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01243216
Collaborator
(none)
0
1
2
46
0

Study Details

Study Description

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 Phase
  • Device: Ultrasound
N/A

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 Design

Study Type:
Interventional
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 :
Oct 1, 2010
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of attempts needed for proper needle placement [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 [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 [30 min]

    Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's and Children's Hospital Columbia Missouri United States 65201

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

  • Principal Investigator: Steven T Fogel, M.D., University of Missouri-Columbia School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01243216
Other Study ID Numbers:
  • 1167437
First Posted:
Nov 18, 2010
Last Update Posted:
Sep 30, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Missouri-Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2016