Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03433612
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
A Novel Method of Improving Accuracy of Anatomical Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
Status:
COMPLETED
Status Verified Date:
2018-10
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:
SAIL
Brief Summary:
This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.
Detailed Description:
The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.
The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.
Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).
The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.
Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: