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

Not Applicable

Withdrawn

• Conditions: Labor Pain; Pregnancy
• Interventions: Device: Ultrasound

• Registration Number: NCT01243216
• Lead Sponsor: 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

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Women's and Children's Hospital; 🇺🇸 Columbia, Missouri, United States