Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

NCT01192074 | Terminated DMC

• 1 other identifier: 1147418
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Attempt Number

  Beginning of placement of epidural or spinal needle to end of placement: average 10 min

Study Arms (1)

Ultrasound of the spine

Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery

Device: Ultrasound

Interventions

Ultrasound DEVICE

Preprocedure ultrasound examination of the spine

Ultrasound of the spine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients in labor Pregnant patients scheduled for cesarean section

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Women's and Children's Hospital

Columbia, Missouri, 65201, United States

Location

Related Publications (5)

• 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.

  PMID: 18319185 BACKGROUND

• 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.

  PMID: 17456672 BACKGROUND

• 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.

  PMID: 19548051 BACKGROUND

• 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.

  PMID: 14656785 BACKGROUND

• 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.

  PMID: 11421838 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Steven T Fogel, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 31, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

US (1)