Clinical trial NCT03433612: Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
Official title: A Novel Method of Improving Accuracy of Anatomical Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Anatomical Landmarks
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will undergo estimation of the L4-L5 interspace using the classic and novel technique, followed by identification of the interspace using lumbar ultrasound.
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* Ultrasound-determined gestation age greater than or equal to 37 weeks
* Expressed interest or indication for epidural anesthesia
* Patients in the first stage of labor

Exclusion Criteria:

* Patients perceived or indicating that she is unable to cooperate with positioning
* BMI greater than 45 kg/m2
* Previous spine surgery or known spinal deformities
* Impaired decision making abilities
* non-English speaking

Primary outcomes:
measure: Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace
timeFrame: From enrollment to the end of data collection, approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Carlo Pancaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pancaro C, Rajala B, Vahabzadeh C, Cassidy R, Klumpner TT, Kountanis JA, McCabe M, Rector D, Aman C, Sankar K, Schoenfeld R, Engoren M. Sacral anatomical interspace landmark for lumbar puncture in pregnancy: A randomized trial. Neurology. 2020 Feb 11;94(6):e626-e634. doi: 10.1212/WNL.0000000000008749. Epub 2019 Dec 12.