Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01192074
First received: August 26, 2010
Last updated: August 30, 2010
Last verified: January 2010
  Purpose

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 Intervention
Pregnancy
Device: Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation of Ultrasound vs Needle Depth [ Time Frame: Beginning of ultrasound exam to end of ultrasound exam: average 5 min ] [ Designated as safety issue: No ]
    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:
  • Attempt Number [ Time Frame: Beginning of placement of epidural or spinal needle to end of placement: average 10 min ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 400
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant Women
Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery
Device: Ultrasound
Preprocedure ultrasound examination of the spine

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  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: NCT01192074

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

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

Publications:
Responsible Party: Steven T Fogel, MD, Department of Anesthesiology and Perioperative Medicine University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01192074     History of Changes
Other Study ID Numbers: 1147418
Study First Received: August 26, 2010
Last Updated: August 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Obstetric
Obstetric Anesthesia
Obstetric Analgesia
Analgesia
Anesthesia
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014