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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01243216
First received: November 16, 2010
Last updated: November 17, 2010
Last verified: September 2010
  Purpose

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 Intervention
Pregnancy
Labor Pain
Cesarean Delivery
Device: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Number of attempts needed for proper needle placement [ Time Frame: 30 min or less ] [ Designated as safety issue: No ]
    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:
  • Time [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia

  • Patient Satisfaction [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243216

Contacts
Contact: Steven T Fogel, M.D. 573-882-2568 fogels@health.missouri.edu

Locations
United States, Missouri
Women's and Children's Hospital Recruiting
Columbia, Missouri, United States, 65201
Contact: Steven T Fogel, M.D.    573-882-2568    fogels@health.missouri.edu   
Principal Investigator: Steven T Fogel, M.D.         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Steven T Fogel, M.D. University of Missouri-Columbia School of Medicine
  More Information

Publications:
Responsible Party: Steven T Fogel MD Associate Professor and Director of Obstetric Anesthesia, University of Missouri
ClinicalTrials.gov Identifier: NCT01243216     History of Changes
Other Study ID Numbers: 1167437
Study First Received: November 16, 2010
Last Updated: November 17, 2010
Health Authority: USA: University of Missouri Health Sciences Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Pregnancy
Labor
Epidural Analgesia
Epidural Anesthesia
Spinal Anesthesia
Ultrasound
Neuraxial Analgesia
Neuraxial Anesthesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014