Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy
• Intervention / Treatment: 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
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients in labor Pregnant patients scheduled for cesarean section

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Ultrasound vs Needle Depth	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	Beginning of ultrasound exam to end of ultrasound exam: average 5 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attempt Number	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	Beginning of placement of epidural or spinal needle to end of placement: average 10 min

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Steven T Fogel, MD, University of Missouri-Columbia

Publications and helpful links

General Publications

• Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
• Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
• Chin KJ, Perlas A, Singh M, Arzola C, Prasad A, Chan V, Brull R. An ultrasound-assisted approach facilitates spinal anesthesia for total joint arthroplasty. Can J Anaesth. 2009 Sep;56(9):643-50. doi: 10.1007/s12630-009-9132-8. Epub 2009 Jun 23.
• Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
• Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): August 31, 2010

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; Analgesia; cesarean section; pregnancy; spinal anesthesia; Anesthesia; epidural analgesia; ultrasonography; labor; Obstetric; cesarean delivery; neuraxial anesthesia; neuraxial analgesia; epidural anesthesia; Obstetric Anesthesia; Obstetric Analgesia
• Other Study ID Numbers: 1147418