NCT02392533

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

March 13, 2015

Last Update Submit

September 24, 2019

Conditions

Infusion Site Anaesthesia

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

  • Ultrasound identification of lumbar interspace

    Number of vertebral levels different between lumbar interspace on palpation versus on ultrasound

    3 months

Study Arms (2)

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

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.

Interventions

EducationOTHER

Education

Pre cohort group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago MEDICINE

Chicago, Illinois, 60601, United States

Location

Related Publications (4)

  • 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.

    PMID: 1515392RESULT

  • 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: 14656785RESULT

  • 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.

    PMID: 12031746RESULT

  • 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.

    PMID: 11069342RESULT

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Barbara Scavone, MD

    The University of Chicago MEDICINE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

January 26, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)