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Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

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ClinicalTrials.gov Identifier: NCT01192074
Recruitment Status : Terminated (Lack of personnel/research time to recruit participants.)
First Posted : August 31, 2010
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.

Condition or disease Intervention/treatment
Pregnancy Device: Ultrasound

Detailed Description:

All patients presenting in labor or are having a cesarean delivery are eligible except: patients who are under age 18, have contraindications to regional anesthesia, in advanced labor, having emergency conditions and/or unable to understand the consent process.

  • Data collected include:
  • Ultrasound depth in transverse and oblique sagittal views
  • Actual needle depth
  • Level of placement
  • Number of separate needle placements
  • Number of needle redirects
  • Angle of probe
  • Angle of needle
  • Total number of attempts
  • Pt height
  • Pt weight
  • Pt BMI
  • Pt age
  • Pt gravity/parity
  • Pt co-morbidities, e.g. pre-eclampsia
  • Procedure performed
  • Operator (Attending, CA-1, CA-2, CA-3, CRNA)

What is currently being examined is the correlation between ultrasound depth of the target area vs actual needle depth


Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
Study Start Date : January 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Ultrasound of the spine
Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery
Device: Ultrasound
Preprocedure ultrasound examination of the spine



Primary Outcome Measures :
  1. Correlation of Ultrasound vs Needle Depth [ Time Frame: Beginning of ultrasound exam to end of ultrasound exam: average 5 min ]
    The ultrasound measured depth taken via oblique sagittal views and transverse views of the epidural space for epidural analgesia or intrathecal space for spinal anesthesia will be correlated with actual needle depth


Secondary Outcome Measures :
  1. Attempt Number [ Time Frame: Beginning of placement of epidural or spinal needle to end of placement: average 10 min ]
    The number of needle placement attemtps: an attempt is defined as a separate needle placement The number of needle redirects: a redirect is defined at the need for changing the angle of needle direction at each separate needle attempt



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients in labor Pregnant patients scheduled for cesarean section
Criteria

Inclusion Criteria:

  • Pregnant women in labor or scheduled for induction requesting labor epidural analgesia
  • Pregnant women scheduled for cesarean delivery
  • Pregnant women in labor who are going to have a non-emergent cesarean delivery under spinal anesthesia

Exclusion Criteria:

  • Emergency delivery
  • Emergency cesarean section
  • Advanced labor
  • Contraindications to neuraxial analgesia/anesthesia
  • Unable to understand consent
  • Under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192074


Locations
United States, Missouri
University of Missouri Women's and Children's Hospital
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Steven T Fogel, MD University of Missouri-Columbia

Publications:
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01192074     History of Changes
Other Study ID Numbers: 1147418
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Keywords provided by University of Missouri-Columbia:
Obstetric
Analgesia
Anesthesia
Obstetric Anesthesia
Obstetric Analgesia
ultrasound
ultrasonography
epidural analgesia
epidural anesthesia
spinal anesthesia
neuraxial anesthesia
neuraxial analgesia
pregnancy
labor
cesarean delivery
cesarean section

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs