Skip to main content
Clinical Trials/NCT01243216
NCT01243216WithdrawnNot Applicable

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

University of Missouri-Columbia1 site in 1 countryStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Number of attempts needed for proper needle placement

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
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

Arms & Interventions

Ultrasound Group

Experimental

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

Intervention: Ultrasound (Device)

No Ultrasound Group

No Intervention

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

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials