Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

Terminated

• Conditions: Pregnancy
• Interventions: Device: Ultrasound

• Registration Number: NCT01192074
• Lead Sponsor: University of Missouri-Columbia

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound of the spine	Ultrasound	Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery

Primary Outcome Measures

Name	Time	Method
Correlation of Ultrasound vs Needle Depth	Beginning of ultrasound exam to end of ultrasound exam: average 5 min	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

Name	Time	Method
Attempt Number	Beginning of placement of epidural or spinal needle to end of placement: average 10 min	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

Trial Locations

Locations (1)

University of Missouri Women's and Children's Hospital; 🇺🇸 Columbia, Missouri, United States