Ultrasound and Neuraxial Anesthesia in Pregnancy (USPREG)

Ultrasound Confirmation of Neuraxial Anesthetic Vertebral Level in Post-partum Patients

Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the fetus, making patients familiar and comfortable with its usage. Ultrasonography does not result in adverse effects to the mother or fetus and is readily available at most facilities, yet is not routinely used to identify lumbar interspaces prior to providing neuraxial anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar intervertebral spaces and is more accurate than simple palpation of obscure anatomic landmarks. The investigators are interested to know the accuracy of anatomic landmark palpation in predicting the lumbar interspace of neuraxial anesthesia administration compared to identification of the interspace by ultrasound. The investigators are also interested in presenting anesthesia providers with feedback regarding their accuracy and then investigating whether this feedback causes a change in provider practice (i.e. use of ultrasound) or improved identification of the interspace prior to providing neuraxial anesthesia.

Study Overview

• Status: Completed
• Conditions: Infusion Site Anaesthesia
• Intervention / Treatment: Other: Education

Detailed Description

Informed consent will be obtained and documented. All post-partum patients who received neuraxial anesthesia will be asked to provide consent for ultrasound to be used at their bedside to identify the interspace where the neuraxial anesthetic was administered. A low frequency ultrasound probe and sterile gel will be used to perform the less than five-minute study. The site of the neuraxial anesthetic placement will be identified by the puncture mark on the skin. The investigators will note the patient's medical record number and BMI, the names of the resident and attending anesthesiologist who placed the neuraxial anesthetic, the documented intervertebral space at the time of neuraxial anesthetic placement, anesthetic type, whether ultrasound was used for the initial neuraxial placement, and the documented intervertebral space identified post-partum by ultrasound.

Following 3 months of data collection, information regarding the documented intervertebral space versus the actual intervertebral space that the neuraxial anesthetic was administered will be provided to each anesthesiologist and resident. Following delivery of this information, an additional 3 months of data collection will be performed (the same as the first 3 months) to evaluate whether a practice change took place.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60601
      • The University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Post-partum patients who had neuraxial anesthesia for their delivery.

Description

Inclusion Criteria: All post-partum patients > 18 years old who had neuraxial anesthesia for delivery and are English Speaking.

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Exclusion Criteria: Age < 18 years and non-English speaking, and did not have neuraxial anesthesia for delivery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre cohort group; Following 3 months of data collection (pre-cohort group), education regarding the documented intervertebral space versus the actual intervertebral space that the neuraxial anesthetic was administered will be provided to each anesthesiologist and resident. Following delivery of this information, an additional 3 months of data collection will be performed (post-cohort group) (the same as the first 3 months) to evaluate whether a practice change took place.	Other: Education; Education
Post cohort group.; Following 3 months of data collection (pre-cohort group), education regarding the documented intervertebral space versus the actual intervertebral space that the neuraxial anesthetic was administered will be provided to each anesthesiologist and resident. Following delivery of this information, an additional 3 months of data collection will be performed (post-cohort group) (the same as the first 3 months) to evaluate whether a practice change took place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound identification of lumbar interspace	Number of vertebral levels different between lumbar interspace on palpation versus on ultrasound	3 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Barbara Scavone, MD, The University of Chicago Medicine

Publications and helpful links

General Publications

• Wallace DH, Currie JM, Gilstrap LC, Santos R. Indirect sonographic guidance for epidural anesthesia in obese pregnant patients. Reg Anesth. 1992 Jul-Aug;17(4):233-6.
• 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, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6.
• Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound
• Other Study ID Numbers: IRB14-1556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO