Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

Pregnancy Clinical Trial

Official title:

Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01192074
• Other study ID #: 1147418
• Status: Terminated
• Phase: N/A
• First received: August 26, 2010
• Last updated: September 2, 2016
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Ultrasound
Preprocedure ultrasound examination of the spine

Locations

Country	Name	City	State
United States	University of Missouri Women's and Children's Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No