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Pancaro 2019
Pancaro 2019
0000000000008749
ARTICLE
®
Neurology 2019;00:1-10. doi:10.1212/WNL.0000000000008749
Abstract
Objective
To determine whether the sacral anatomical interspace landmark (SAIL) technique is more
accurate than the classic intercristal line (ICL) technique in pregnant patients and to assess the
percentage of clinical determinations above the third lumbar vertebra.
Methods
In this prospective, randomized, open-label trial, there were 110 singleton pregnant patients
with gestational age greater than 37 weeks included. Selection procedure was a convenience
sample of pregnant patients who presented for office visits or vaginal or cesarean delivery
between March 15 and July 31, 2018, at a single-center obstetric tertiary care university hospital.
Both techniques were evaluated by 2 physicians independently assessing each method. Before
data collection, we hypothesized that the SAIL technique would be more accurate than the ICL
technique in determining the L4-L5 interspace, and that the SAIL technique would produce
more estimations below the third lumbar vertebra than the ICL technique. Therefore, the
primary outcome was accuracy in identifying the L4-L5 lumbar interspace with SAIL vs ICL.
The secondary outcome was difference in clinical assessments above the third lumbar vertebra.
Both outcomes were measured via ultrasonography.
Results
Patients were 31 ± 5 years of age (mean ± SD) and had body mass index of 31.8 ± 5.7 kg/m2 and
gestational age of 38.8 ± 1.1 weeks. A total of 110 patients were analyzed. SAIL correctly
identified the L4-L5 interspace 49% of the time vs 8% using ICL (p < 0.0001). Estimations
above L3 were 1% for SAIL vs 31% for ICL (p < 0.0001).
Conclusions
Our study shows improved accuracy in identifying intervertebral space using the SAIL tech-
nique; this may prevent direct mechanical trauma to the conus medullaris when lumbar
punctures are performed in pregnancy.
Clinicaltrials.gov identifier
NCT03433612.
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
In the United States, at least 360,0001 diagnostic lumbar delivery. Patients who were not in labor and those in first stage
punctures (LPs) are performed annually, many without ra- of labor were eligible for recruitment. Patients in labor who
diologic guidance.2 In addition, nearly 1 million spinal anes- were perceived by the nurse or the clinician to be unable to
thetics, also performed by LP without imaging guidance, are cooperate with positioning were excluded. In addition,
administered in pregnant patients undergoing cesarean de- patients who had undergone a previous spine surgery, who
livery.3 The intercristal line (ICL) clinical method is the most had known spinal deformities, who had impaired decision-
widely employed method to identify the LP site.4,5 In preg- making abilities, who had a body mass index (BMI) greater
nancy, the ICL method leads to misidentification of the L4-L5 than 45, or who were non-English-speaking were also
interspace 86% of the time,6 causing the provider to enter excluded.
a higher than intended interspace,7 with consequent risk of
mechanical trauma to the conus medullaris,4,8 increasing the Recruitment and randomization
risk of major morbidity.9 To our knowledge, there are no The study was performed on days that authors C.P., B.R., and
studies evaluating a clinical identification technique alterna- C.V. were available. A convenience sample of eligible patients
tive to the ICL method to perform LPs. The sacral anatomical was recruited during office visits or upon presentation to the
interspace landmark (SAIL) technique consists of identifying labor and delivery unit. Once written consent was obtained,
the sacrum by palpation. The provider’s hand slides cephalad a study ID number was assigned and demographic in-
along the dorsal surface of the sacrum in order to identify the formation was collected: age, height, weight, BMI, and ges-
first interspace between the sacrum and the last lumbar ver- tational age. Both the operator order (C.P. or B.R. going first)
tebra (L5-S1). Once the L5-S1 space has been identified, the and the operator technique (whether C.P. or B.R. performed
provider’s hand slides cephalad 1 more interspace to identify ICL or SAIL) were randomized, using a computer-generated
the L4-L5 landmark space. randomization tool (randomizer.org/) in blocks of 10
patients. Using this procedure, both techniques were studied
We hypothesized that the SAIL technique is more accurate in in 110 patients by both providers. Each provider performed
identifying the L4-L5 interspace than the classic ICL tech- 55 ICL and 55 SAIL assessments. Each estimation technique
nique in pregnancy. We also hypothesized that the SAIL (ICL and SAIL) was performed by 2 obstetric anesthesiolo-
technique produces more estimations below the third lumbar gists (C.P. and B.R.), who both have more than 10 years of
vertebra than the ICL technique. The primary outcome was clinical experience performing LPs.
correct identification of the L4-L5 interspace. The secondary
outcome was the occurrence of measurements that fell Clinical estimate technique
above L3. Patients were positioned sitting to one side of a level stretcher
with the neck, back, and hips flexed. The hips were positioned
with the weight distributed evenly between both sides. An
Methods assistant stood facing the patient helping to maintain her
position, if needed.
Standard protocol approvals, registrations,
and patient consents The ICL technique consists of first palpating the posterior
The University of Michigan institutional review board (IRB) iliac crests (figure 2A). Then, the provider’s hand slides me-
approved this prospective randomized observational study dially along an imaginary line connecting the 2 posterior iliac
(IRB HUM00109509). Before enrollment began, the study crests (figure 2B). This line is said to cross the midline at the
was registered at clinicaltrials.gov (NCT03433612). All items L4 vertebrae or L4-L5 interspace. If the provider palpates
of the Strengthening the Reporting of Observational Studies a spinous process, this would be regarded as L4 and the
in Epidemiology (STROBE) statement checklist10 were fol- provider’s nondominant hand would slide 1 interspace cau-
lowed. The STROBE flow diagram is shown in figure 1. All dally to the L4-L5 interspace. If the provider palpates an
participants gave written consent to participate in the study. intervertebral space, the palpated interspace is presumed to be
the L4-L5 intervertebral space.
Patients and enrollment
A total of 110 pregnant patients older than 18 years with The SAIL technique consists of first identifying the dorsal aspect
a singleton gestation and at ultrasound-determined gesta- of the sacrum by palpation (figure 2C). Once the lowest part of
tional age of 37 weeks or greater were enrolled before the sacrum has been palpated, the provider’s hand slides ceph-
placement of neuraxial blockade for cesarean or vaginal alad to the dorsal surface of the sacrum in order to identify the
first interspace between the sacrum and the last lumbar vertebra, performed the SAIL technique and the other investigator
the L5-S1 interspace. Then, once the L5-S1 intervertebral space performed the ICL technique. The investigator performing
has been identified, the provider’s hand will slide up 1 more each technique was reversed for the other 55 patients.
interspace in order to identify the L4-L5 interspace (figure 2D).
A third provider (C.V.), experienced with lumbar ultraso-
Using these 2 techniques, 2 providers consecutively marked nography and blinded to the 2 clinical estimates, scanned with
the patient’s skin with an erasable pen at the estimated L4-L5 ultrasound the lumbo-sacral area in the same flexed position
level as previously described.6 The ICL technique findings and marked with an erasable pen the vertebral levels L1, L2,
were marked, with a short 1/2 inch horizontal line, on the skin L3, L4, L5, S1 and the intervertebral levels L1-L2, L2-L3, L3-
covering the areas where the left posterior axillary and the left L4, L4-L5, L5-S1, as previously described.6
scapular lines intersect cranio-caudally: the latissimus dorsi,
external oblique, gluteus medius, and gluteus maximum. The Ultrasound equipment and technique
ICL technique mark was then concealed with a folded 40 × 40 A portable SonoSite Inc. Edge (Bothell, WA) ultrasound
woven gauze swab and tape. Likewise, the SAIL technique system, fitted with a 4-MHz C60X curved array probe, was
findings were marked as above on the right side and the used to determine the vertebral and intervertebral spaces. The
markings concealed. The skin markings were aided by using probe was applied in the paramedian longitudinal plane to
a 30-cm ruler with an embodied spirit level to ensure that visualize the sacrum and the interlaminar spaces individually.
markings were at the same level of the palpation over the The interlaminar space between the L5 vertebra and the sa-
spine. The folded 40 × 40 woven gauze swab and tape was used crum was identified first. The L5 level was marked on the skin
so that each physician was blinded to the other’s estimation. at the midpoint of the probe by positioning the L5 lamina in
The first physician made sure that covering the marking did the center of the screen, as previously described.6 The L4 to
not interfere with the next physician’s ability to accurately L1 levels were identified and marked moving cephalad. The
assess and determine the interspace level with the other sacrum was marked in a similar manner moving caudally. The
technique. In half (n = 55) of the patients, 1 investigator marks for the ICL and SAIL clinical estimates were then
(A, B) Classic technique. The classical intercristal line technique consists of first palpating the posterior iliac crests (A). Then, the provider’s hand slides medially
along an imaginary line connecting the 2 posterior iliac crests to locate the estimated interspace (B). (C, D) The SAIL technique consists of first palpating the
lowest part of the dorsal aspect of the sacrum. The provider’s hand then slides cephalad along the dorsal surface of the sacrum in order to identify the first
interspace between the sacrum and the last lumbar vertebra, the L5-S1 interspace (C). Then, once the L5-S1 intervertebral space has been identified, the
provider’s hand slides cephalad 1 more interspace to identify the L4-L5 interspace (C, D).
uncovered and the corresponding vertebral and intervertebral McNemar test for marginal homogeneity. The primary null
levels were noted. An assistant reported the levels as follows: hypothesis was that the success and failure rates for the ICL
L1 = 1, L1-L2 = 1.5, L2 = 2, L2-L3 = 2.5, L3 = 3, L3-L4 = 3.5, and SAIL techniques are the same. The secondary outcome
L4 = 4, L4-L5 = 4.5, L5 = 5, L5-sacrum = 5.5, sacrum = 6. was the frequency of measurements that fell above the third
lumbar vertebra. This secondary outcome was also assessed
Statistical analysis for homogeneity across technique (ICL/SAIL) using the
The primary outcome was the correct identification of the L4- McNemar test. The secondary null hypothesis was that the
L5 interspace with each technique, ICL and SAIL. Observed probability of a measurement falling above the third lumbar
success rates were compared between techniques using the vertebra is the same for the ICL and SAIL technique.
The mode produced by the classic technique was the L3-L4 interspace while the mode produced by the SAIL technique was the L4-L5 interspace. Median level
identified (interquartile range): classic ICL: L3-L4 interspace (L2, L3-L4 interspace) vs SAIL: L4-L5 interspace (L4, L4-L5 interspace), p < 0.0001, Wilcoxon signed-
rank test.
distance from the L4-L5 level, on average (table 2). No de- associated with absolute distance |ICL–SAIL| between the 2
mographic factors were significantly associated with either techniques. For every decade (10-year) increase in age, the
distance or absolute distance between the true L4-L5 level and average absolute distance between the 2 estimates increased by
the ICL-estimated level. Only age was found to be significantly about 0.31. Therefore, an increase of 33 years of age is
ICL estimate 2.5 L2-L3 3.5 (1); L3-L4 (1) 3.5 L3-L4 1 L1 5.5 L5-Sacrum
SAIL estimate 4 L4 4.5d (0.5); L4-L5 (0.5) 4.5d L4-L5 2.5 L2-L3 5.5 L5-Sacrum
associated with approximately a 1-interspace increase in the of the L4-L5 interspace. One possibility is that the cephalad
absolute distance between techniques (table 2). end of a prominent median sacral crest (the rudimentary
fusion of sacral spinous processes) could have been mistaken
for the lumbo-sacral interspace, and the second cephalad in-
Discussion terspace counting upward was therefore erroneously esti-
mated as L4-L5. Given sacral bone anatomical variations,15,16
The SAIL technique is more accurate than the ICL technique
we do not know whether the absence or the incomplete
in the identification of the L4-L5 interspace. More impor-
genesis of the median sacral crest could lead to better accuracy
tantly, the current study shows that even when the identifi-
in determining the desired intervertebral space when the SAIL
cation of the L4-L5 interspace is incorrect, the SAIL technique
method is used. Another hypothesis as to why the L5-S1
is within 1 space 98% of the time. Moreover, 99% of in-
interspace was incorrectly identified as L4-L5 is that even
terspace identifications using the SAIL technique were below
L3, the lowest point where the conus medullaris may be though the apex of sacral hiatus is most commonly located at
found,12 minimizing the theoretical risk of needle injury to the the S4 level, in 3%–15% of cases it can terminate as high as the
spinal cord. Conversely, when the ICL technique estimate is S1, S2, and S3 levels,17,18 potentially misleading the clinician
not accurate, the intervertebral space is almost always higher to feel this gap as the lumbosacral interspace, and sub-
than L4-L5, and 30% of the time is even more cephalad sequently causing an erroneous, more caudal estimation of the
than L3. L4-L5 interspace as the palpation moves cephalad.
The position of the conus medullaris has been reported to be Using the sacrum as the initial clinical point of reference could
lower in females than in males.13 A combination of a low theoretically lead the clinician to inaccurately make a lower
position of the conus medullaris and a higher clinical esti- assessment than the lumbo-sacral interspace. However, using
mation of the targeted interspace might increase the risk of the SAIL method, no assessments were made lower than the
contact between the tip of the spinal needle and the spinal L5-S1 interspace, implying that whenever a LP is to be per-
cord, putting patients at higher risk of neurologic injury.9 Of 7 formed there is always a chance to reach a vertebral interspace
reported conus injuries, 6 occurred in pregnant patients re- for the purpose of CSF sampling or drug delivery. However, in
ceiving spinal or combined spinal epidural blocks, most be- contrast to the ICL method, the SAIL method is less likely to
lieved to be at the L2-3 interspace.9 Furthermore, the inaccurately make a high assessment, leading to a potentially
American Society of Anesthesiologists’ Closed Claims data- dangerous puncture at the conus medullaris level.
base reported that 2 spinal cord injuries that resulted in
paraplegia were attributable to direct drug injection into the In addition, lumbosacral transitional vertebrae such as the
spinal cord.14 sacralization of the fifth lumbar vertebra or the lumbarization of
first sacral vertebra can mislead the clinician to an improper
In 19% of cases, the SAIL technique incorrectly identified L5- identification of the correct interspace.19 In either situation,
S1 as L4-L5. We hypothesize that in those assessments there when using the SAIL technique, the first palpable interspace
was anatomical variability leading to more caudal estimation would actually be the L4-L5 intervertebral space and the
ICL technique
Age decade (10 years) 0.07 (−0.22 to 0.36) 0.6338 −0.06 (−0.36 to 0.24) 0.6917
Gestational age (weeks) 0.03 (−0.09 to 0.16) 0.6223 −0.05 (−0.18 to 0.08) 0.4191
SAIL technique
Age decade (10 years) −0.07 (−0.27 to 0.13) 0.4709 0.23 (−0.03 to 0.48) 0.0791
Gestational age (weeks) −0.02 (−0.10 to 0.07) 0.7140 −0.10 (−0.21 to 0.01) 0.0683
BMI (10 kg/m2) 0.05 (−0.12 to 0.21) 0.5802 −0.30 (−0.51 to −0.08) 0.0073
Age decade (10 years) 0.31 (0.01 to 0.60) 0.0430 −0.29 (−0.61 to 0.04) 0.0801
Gestational age (weeks) −0.09 (−0.22 to 0.04) 0.1517 0.05 (−0.09 to 0.19) 0.4867
BMI (10 kg/m2) −0.21 (−0.46 to 0.04) 0.1011 0.20 (−0.07 to 0.47) 0.1522
Abbreviations: BMI = body mass index; CI = confidence interval; ICL = intercristal line; SAIL = sacral anatomical interspace landmark technique.
second palpable interspace would actually be the L3-L4 in- The results of these studies reflect the inherent variability of the
terspace. Because of the use of ultrasound in this study to define ICL technique. The ICL’s normal distribution ranges from as
each interspace, it remains unknown whether the patients in- low as the L5-S1 interspace to as high as the L3-4 interspace in
cluded in this study had lumbosacral transitional vertebrae. nonpregnant patients.23 The variability of ICL distribution in
pregnancy is greater than in nonpregnant patients, where the
Our results are consistent with what other investigators have ICL determined by radiograph coincides with the L4 spinous
reported when assessing the LP site chosen by the ICL process or the L4-5 interspace 78.6% of the time but is as high
technique. Studying 51 pregnant patients, 2 experienced as the L3-4 interspace in only 3.7% of patients.24 In addition,
anesthesiologists were able to accurately determine the L4-L5 the soft tissue residing on top of the iliac crests is likely in-
interspace in only 14% of their assessments.6 In another study, creased in pregnancy, leading the clinician to higher than an-
when physicians examined 45 pregnant patients, they found ticipated assessment when using the ICL method.
that the palpated ICL was located above the L4-L5 interspace
in all women enrolled in their study.20 Similarly, other In obese patients, the ICL method can be challenging,25 and
investigators found by ultrasound confirmation after LP that 6 palpation of sacral interspaces through the SAIL can be con-
LPs in 99 patients were carried out at the L1-L2 interspace, sidered as an alternative. However, we found that a significant
with a considerable risk of needle contact with the conus increase in BMI was associated with a 1-interspace decrease in
medullaris.7 Moreover, when a team of 4 anesthesiologists the SAIL-estimated distance from the L4-L5 level, but the
with more than 5 years of experience in performing routine clinical significance of this finding remains to be established.
LPs studied 100 consecutive patients, the clinical estimation
of the correct interspace occurred 29% of the time, as con- This study has several limitations. First, even though clinicians
firmed by MRI findings, with the actual space identified being have been performing caudal anesthesia for many decades, the
higher than assumed 68% of the time.21 In another study, anatomical landmarks for caudal blocks do not take into
palpation successfully identified the intended interspace in consideration the palpation of sacral structures that are
only 30% of cases, and intervertebral spaces in up to 27% of cephalad to the sacral hiatus and cornua.26 Therefore, clini-
cases were incorrectly identified by more than 1 level.22 cians may not be familiar with the palpation of the area above
performed exclusively in pregnant patients, so the generaliz- Christie University of Author Assisted with data collection
ability of our findings to the pediatric, male, elderly, and Vahabzadeh, Michigan, and performed lumbo-sacral
MD Ann Arbor ultrasound, interpreted data,
nonpregnant population remains undetermined. It is possible revised manuscript for
that other anatomic characteristics, unique to these other intellectual content
populations, affect the accuracy of each estimation technique. Ruth Cassidy, University of Author Performed statistical
Nonetheless, our findings strongly suggest that the conven- MA Michigan, analysis, interpreted data,
Ann Arbor revised manuscript for
tional ICL method for estimation of the site of LP should be intellectual content
reevaluated. Future studies should determine if our findings
Thomas T. University of Author Interpreted data, revised
can be reproduced in different patient populations, by a vari- Klumpner, Michigan, manuscript for intellectual
ety of medical practitioners, across diverse clinical settings. MD Ann Arbor content
likely to result in an estimation below L3. Whenever ultrasound Madeline University of Author Recruited patients, assisted
or radiology guidance is not available, neurologists, emergency McCabe Michigan, with data collection,
Ann Arbor interpreted data, revised
medicine physicians, neurosurgeons, primary care physicians, manuscript for intellectual
intensivists, anesthesiologists, and others who perform LPs content
might find an estimation technique that reduces the risk of Dana Rector University of Author Recruited patients, assisted
misidentification of a higher lumbar interspace, like the SAIL Michigan, with data collection,
Ann Arbor interpreted data, revised
technique, useful in avoiding potential needle contact with the manuscript for intellectual
conus medullaris. However, further research is needed before content
this novel technique can be implemented in clinical practice. Casey Aman University of Author Assisted with data collection,
Michigan, interpreted data, revised
Acknowledgment Ann Arbor manuscript for intellectual
content
The authors thank Virginia E. Fulford, MS, CMI, Alar
Illustration, for artwork. Keerthana University of Author Designed and acquired
Sankar Michigan, approval for study
Ann Arbor
Study funding
Robert University of Author Designed and acquired
This study was funded by the University of Michigan De- Schoenfeld Michigan, approval for study
partment of Anesthesiology. Ann Arbor
Publication history
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Carlo University of Author Designed and conceptualized of the intercristal line in pregnancy. Anesth Analg 2011;113:559–564.
Pancaro, MD Michigan, study, performed clinical 7. Schlotterbeck H, Schaeffer R, Dow WA, Touret Y, Bailey S, Diemunsch P. Ultraso-
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Updated Information & including high resolution figures, can be found at:
Services http://n.neurology.org/content/early/2019/12/12/WNL.0000000000008
749.full
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