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Clinical Trials/NCT01243216
NCT01243216
Withdrawn
Not Applicable

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

University of Missouri-Columbia1 site in 1 countryOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of Missouri-Columbia
Locations
1
Primary Endpoint
Number of attempts needed for proper needle placement
Status
Withdrawn
Last Updated
9 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
August 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Patient Satisfaction(30 min)
  • Time(30 min)

Study Sites (1)

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