Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Patients | Other | Estimates of the location of the L4-L5 intervertebral space will be done by the classic intercristal line technique and novel SAIL technique. Each technique will be performed by different randomly assigned investigators. * Both techiques will be assessed on all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classic Intercristal Line Technique | Other | Researcher will use the classic technique to estimate the L4-L5 interspace. The classic technique begins by palpating both the right and left posterior iliac crests and following the imaginary line that intersects each (intercristal line) with the non-dominant hand to the spine where it is estimated to intersect the L4 spinous process or L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace | Percentage of trials for the novel and classic technique respectively that the estimation correctly matches the L4-L5 interspace as determined by lumbar paramedian ultrasound will serve as a measure of accuracy | From enrollment to the end of data collection, approximately 15 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlo Pancaro, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31831599 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
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.
Not provided
Not provided
The estimation marks from each technique (two total) will be on the back of the patient (one on the left flank, one on the right flank), therefore the patient does not know where the marks are. Additionally, each mark will be covered with a taped on gauze pad to conceal it so that the two investigators are blinded to each others assessment. The ultrasound clinician will be masked to the two estimations. The marks will still remain covered while the interspace is determined by the third assessor using lumbar ultrasound.
Not provided
|
|
| Novel SAIL Technique | Other | Researcher will use the novel technique to estimate the L4-L5 interspace. The SAIL technique begins by palpating the sacrum and the researcher sliding the non-dominant hand up the dorsal surface of the sacrum to the first interspace (L5-S1) and then up one more interspace to estimate the L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique. |
|
|