Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Pregnant patients in labor Pregnant patients scheduled for cesarean section
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
Contact: Steven T Fogel, MD | 573-882-2568 | fogels@health.missouri.edu |
United States, Missouri | |
University of Missouri Women's and Children's Hospital | Recruiting |
Columbia, Missouri, United States, 65201 | |
Principal Investigator: Steven T Fogel, MD |
Principal Investigator: | Steven T Fogel, MD | University of Missouri-Columbia |
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 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 |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012