Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 12:06 PM
Study NCT ID:
NCT02392533
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound and Neuraxial Anesthesia in Pregnancy
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
Ultrasound Confirmation of Neuraxial Anesthetic Vertebral Level in Post-partum Patients
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USPREG
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: