d

1. EFFICACY OF PRE-PROCEDURAL ULTRASOUND OF
LUMBAR SPINE IN IMPROVING THE PROCEDURAL
SKILL OF SUBARACHNOID BLOCK
DR. P R ARTHI
REG. NO: 1601021003 | JULY/2016 OF ADMISSION | MAY/2016 YR OF
EXAMINATION
M.D ANAESTHESIOLOGY, MGMCRI
GUIDE
DR. V R HEMANTH KUMAR
PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI
Co-GUIDE
DR. ARCHANA ARETI
SENIOR RESIDENT
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI
Co-GUIDE
DR. V JAYA
ASSISSTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

2. 2
CANDIDATE
 Candidate Name :Dr. P R Arthi
 Course of Study : MD ANAESTHESIOLOGY
 University Identity No : 1601021003
 Mobile Phone No : +919487547071
 E-mail Address : arthi.pre@gmail.com
 Month/Yr of Admission : JUNE 2016
 Month/Yr of Examination : MAY 2019
GUIDES
 GUIDE: DR. R V HEMANTH KUMAR
 Professor
 Department of Anaesthesia and Critical Care
 9003550553
 drvrhk@gmail.com
 CO GUIDE: DR. ARCHANA ARETI
 Senior Resident
 Department of Anaesthesia and Critical Care
 8374237095
 archanaareti@gmail.com
 CO GUIDE: DR.V JAYA
 Assistant Professor
 Department of Anaesthesia and Critical Care
 9843804054
 jayav@mgmcri.ac.in

3. 3
PART II – THE PROTOCOL
1 INTRODUCTION
Spinal anaesthesia is one of the commonest procedures performed, and one of the
first skills to be acquired by an anaesthesiologist. It requires considerable skill, and
demands a precise and total understanding of regional anatomic relationships1
.
Acquiring adequate knowledge of the anatomy and orientation of central neuraxis,
for performance of a successful block, is still largely based on the “blind” landmark
based procedure. Radiological examination and simulation based training techniques
have been employed successfully, to better aid the teaching process2
.
In recent times, Ultrasonography has shed light in various aspects in clinical
anaesthesia, and has proven to be a useful tool for point of care procedures.
Pertaining to central neuraxial blockade, USG guided procedures have been proven
to identify and navigate the difficult anatomy3
, but because the procedure is time
taking and there pose some difficulty in obtaining clear images, it is not routinely
used in clinical practise4
. However in a setting where practise makes perfect, to
include its application as a teaching tool for the normal anatomy, may prove to
improve the technique of lumbar puncture for spinal anaesthesia in normal as well as
difficult anatomy, thereby reducing the distress experienced by the patient with
multiple attempts at spinal anaesthesia, also reducing incidence of associated
complications (e.g hematoma, post dural puncture headache)5
. This study is
designed to evaluate if a preprocedural ultrasonographic examination of the lumbar
spine, improves the performance of lumbar puncture for spinal anaesthesia.

4. 4
2 AIMS AND OBJECTIVES
Aim
To evaluate the efficacy of Pre-procedural Ultrasound of Lumbar spine in improving
the procedural skill of Subarachnoid block.
Objectives:
1. Incidence of Procedural success within first needle pass
2. Number of needle passes to achieve successful procedure
3. Number of attempts
4. Time taken for performance of procedure
5. Incidence of procedural failure
3 REVIEW OF LITERATURE
1. Levy JH et al conducted a retrospective study of the incidence and causes of
failed spinal anesthetics in a university hospital. One hundred sequential spinal
anesthetic procedures were reviewed retrospectively to study specifically the
incidence and causes of failed spinal anesthesia. Variables examined included the
patient population, the technical aspects of performing subarachnoid tap and
subsequent blockade, and the level of training of the anesthetists. They found a
17% incidence of spinal failure, defined as the need to use general anesthesia
during the surgical procedure. Failure was found to be significantly associated
with a lack of free flow of cerebral spinal fluid, the use of tetracaine without
epinephrine, and an increased administration of intravenous supplementation.
Forty-one% of the failures represented errors in judgement, either in not properly
anticipating the duration of surgery or injecting local anesthetic solution in the
absence of a free flow of cerebral spinal fluid. An incidental finding was the lack
of documentation in many of the variables examined. They attributed the high
incidence of failed spinal anesthesia mainly to technical reasons, most of them
avoidable. The use of local and regional anesthesia requires considerable
technical skills and demands a precise and total understanding of regional

5. 5
anatomic relationships. They concluded that spinal and epidural anesthesia,
continue to be utilized widely; and even though these techniques, safe as they are,
are being poorly taught.
2. Udani DA et al evaluated a simulation-based mastery learning with deliberate
practice to improve the clinical performance in spinal anesthesia. 21 anesthesia
residents were enrolled. After baseline assessment of SAB on a task-trainer, all
residents participated in a base curriculum. Residents were then randomized so
that half received additional deliberate practice including repetition and expert-
guided, real-time feedback. All residents were then retested for technique. SABs
on all residents’ next three patients were evaluated in the operating room (OR).
Before completing the base curriculum, the control group completed 81% of a
16-item performance checklist on the task-trainer and this increased to 91% after
finishing the base curriculum (<0.02). The intervention group also increased the
percentage of checklist tasks properly completed from 73% to 98%, which was a
greater increase than observed in the control group (< 0.03). The OR time
required to perform SAB was not different between groups. In conclusions
thebase curriculum significantly improved resident SAB performance, Deliberate
practice training added a significant, independent, incremental benefit. The
clinical impact of the deliberate practice intervention in the OR on patient care is
unclear.
3. Weed JT et al evaluated the use of pre-procedure ultrasound examination as a
screening tool for difficult spinal anaesthesia. They performed a pre-procedure
ultrasound examination of the spine on 60 patients undergoing lower extremity
orthopaedic surgery under spinal anaesthesia. They hypothesised that the
inability to identify the posterior longitudinal ligament or vertebral body easily
with ultrasound would be associated with difficulty placing a spinal anaesthetic.
Clinicians blinded to the ultrasound scan performed the injections using the
traditional landmark technique. The spinal procedure was videotaped and
subsequently reviewed by independent investigators. They defined procedure
difficulty by total procedure time (> 400 s) and number of needle passes (10)
required to achieve return of cerebrospinal fluid, or abandonment of the
procedure due to unsuccessful dural puncture. When images of the posterior
longitudinal ligament were poor (low score group), the mean (SD) number of

6. 6
passes was 21.2 (30.6), compared with 4.8 (7.5) with good ultrasound images
(high score group) (p < 0.01). The mean (SD) time for placement was 420 (300) s
in the low score group vs 176 (176) s in the high score group (p < 0.01). In
conclusion, the data not only support the existing evidence that ultrasound
imaging of the PLL is a reliable indicator for an open window to the intrathecal
space, it also emphasises the potential role that ultrasound can play in the
decision-making process. Ultrasound may allow us to predict which patients are
at risk for a prolonged procedure involving multiple needle passes. Even more
convincing is its ability to predict when the procedure will be easy. While
certainly helpful to clinicians, this strategy could also empower patients who are
weighing the risks and benefits of their anaesthetic options. Patients ambivalent
regarding a spinal anaesthetic may opt for general anaesthesia if ultrasound
examination is discouraging. Alternatively, these patients could be reassured
with favourable ultrasound findings. They concluded that whether it is used to
facilitate such a dialogue or simply to identify an optimal insertion site,
ultrasound represents an additional technology at the anesthesiologist’s disposal.
4. Chin KJ et al published Ultrasonography of the adult thoracic and lumbar spine
for central neuraxial blockade, in Anesthesiology 2011. Ultrasound guidance has
revolutionized regional anesthesia, but its application in neuraxial blockade has
not yet enjoyed the popularity, even though spinal and epidural anesthesia are the
most widely used regional anesthetic techniques. This can be attributed both to
the efficacy of the traditional landmark-guided technique of neuraxial blockade
and to the limitations of ultrasonography of the adult spine. Ultrasonographic
visualization of structures encased within the bony vertebrae in adults is possible
only through the interlaminar spaces between adjacent vertebrae. However, this
is also the basis for the utility of ultrasound in neuraxial blockade: if an
interlaminar window that permits passage of sound waves into the vertebral canal
can be identified, the same window will permit passage of a needle into the
epidural or intrathecal space.In addition, ultrasound aids in identification of
intervertebral levels, estimation of the depth to epidural and intrathecal spaces,
and location of important landmarks, including the midline and interlaminar
spaces. This can facilitate neuraxial blockade, particularly in patients with
difficult surface anatomic landmarks. In this review article, the authors

7. 7
summarize the current literature, describe the key ultrasonographic views, and
propose a systematic approach to ultrasound imaging for the performance of
spinal and epidural anesthesia in the adult patient.
5. Srinivasan K et al evaluated conventional landmark-guided midline versus
preprocedure ultrasound-guided paramedian techniques for spinal anesthesia.
One hundred consenting patients scheduled for elective total joint replacements
(hip and knee) were randomized into group C (conventional) and group P
(preprocedural ultrasound-guided paramedian technique) with 50 in each group.
The patients were blinded to the study group. In group C, spinal anesthetic was
done via the midline approach using clinically palpated landmarks. In group P, a
preprocedural ultrasound scan was used to mark the paramedian insertion site,
and spinal anesthetic was performed via the paramedian approach. The average
number of passes in group P was approximately 0.34 times that in group C, a
difference that was statistically significant (P = 0.01). Similarly, the average
number of attempts in group P was approximately 0.25 times that of group C (P =
0.0021). In group P, on an average, it took 81.5 (99% confidence interval, 68.4–
97 seconds) seconds longer to identify the landmarks than in group C (P =
0.0002). All other parameters, including grading of palpated landmarks, time
taken for spinal anesthetic injection, periprocedural pain scores, periprocedural
patient discomfort visual analog scale score, conversion to general anesthetic,
paresthesia, and radicular pain during needle insertion, were similar between the
2 groups. They concluded that routine use of paramedian spinal anesthesia in the
orthopedic patient population undergoing joint replacement surgery, guided by
preprocedure ultrasound examination, significantly decreases the number of
passes and attempts needed to enter the subarachnoid space.
4 RESEARCH QUESTION OR HYPOTHESIS
Pre procedural ultrasonographic examination of lumbar spine improves the
performance of subarachnoid block.

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5 SUBJECTS AND METHODS
5.1 STUDY SUBJECTS
The Study InvolvesHUMANS
5.2 TYPE OF STUDY
Randomised, single blinded Clinical Trial
5.3 PLACE OF STUDY
Dept of Anaesthesiology, Mahathma Gandhi Medical College and Research Institute
5.4 SELECTION PROCESS
5.4.1 STUDY POPULATION
All patients posted for elective surgery under spinal anaesthesia
5.4.2 VOLUNTEERS RECRUITEMENT PROCESS
Not Applicable
5.4.3 INCLUSION CRITERIA
 Patients scheduled for surgery under subarachnoid block
 Age 18-75 years
 ASA grade I and II
5.4.4 EXCLUSION CRITERIA
 Patient refusal
 Contraindication for spinal anaesthesia – infection at site, coagulopathy,
allergy to local anaesthetics

9. 9
 Spinal deformity
 BMI > 35, Pregnancy
 Previous spine surgery
 Lower limb fractures
5.4.5 SAMPLING PROCEDURE
Continuous sampling, patients will be randomised into 2 groups by sealed envelope
technique.
5.4.6 STUDY GROUPS
The Number of Groups is: 2
Specify the Groups: Group LM – Landmark based procedure
Group US– preprocedural USG based technique
5.4.7 SAMPLE SIZE
Levy et al reported a failure rate for landmark based spinal anaesthesia to be 17%.
To reduce this incidence to 4%, with alpha of 0.05 and beta 80%, we calculated
sample size, using formula given below, to be 87 per group.
Considering drop out we took sample size to be 100 patients.

10. 10
5.5 METHODOLOGY / PROCEDURES:
After obtaining ethical committee approval and informed consent, 200 patients
satisfying inclusion and exclusion criteria will be recruited for the study by
continuous sampling.
The anaesthesiologists performing the subarachnoid blocks will receive a teaching
module of spine anatomy and ultrasonography of central neuraxis along with
phantom training prior to performing the procedures.
After under going preoperative evaluation, the patients will receive premedication as
per institute protocol on the night before and day of surgery. On the day of surgery
the patients will be shifted to the pre anaesthetic procedure room.
In the procedure room, after connecting the standard monitors (electrocardiogram,
pulsoximetry and non invasive blood pressure monitor), appropriate IV acsess with
an 18G venous cannula will be secured. After patient placed in right or left lateral
position, the patients will be randomised by sealed envelope technique to be in either
Group LM or Group US.
In Group LM, the performer of the subarachnoid block will identify and mark the
L2,3 and 4 spinous procesess, the widest interspinous space, with a marker on the
skin, by traditional palpatory landmark based technique.
In Group US, the performer will perform a preprocedural scan of the lumbar spine,
by using Sonosite X porte (Sonosite, Bothwell, WA, USA) ultrasound system with
multibeam capability(compound imaging), low frequency curvilinear probe C60 (2-
5Hz). A median sagittal view (midline) of the neuraxis will be obtained and the
sacrum identified, and then on scanning cephalad, the L5 – S1 space will be noted.
Subsequent interspinous spaces will be identified counted and marked. A transverse
spinous process view will be used to identify the spinous procesess. The

11. 11
interspinous space at the which the clearest image of the posterior complex
(ligamentum flavum and posterior dura)and anterior complex (anterior dura and
vertebral body)is obtained and marked. Also the depth to the posterior complex is
approximated, and the angle at which probe is tilted is also noted.
From the procedure room, the patients in both the groups will be transferred to the
concerned OT, and the subarachnoid block will be perfomed as per institute
departmental protocol after following a preprocedural checklist, by the
anaesthesiologist who has identified the landmarks in the procedure room.
The performance of the subarachnoid block will be assessed by the consultant
anaesthesiologist who was not present in the procedure room, and so is blinded to
whether the performer has done a pre procedural USG scan. The OT consultant will
assess the procedure by noting
1. Noting the procedural success in first needle pass – Acheivement of CSF in
first pass of needle
2. The number of needle passes - defined as the number of forward
advancements of the spinal needle in a given interspinous space, i.e.,
withdrawal and redirection of spinal needle without exiting the skin
3. The number of attempts - defined as the number of times the spinal needle is
withdrawn from the skin and reinserted
4. The time taken to detect CSF – time from first needle insertion till CSF
detection.
A maximum of 3 attempts will be allowed for the performer. After 3 attempts, it will
be considered as a procedural failure, following which the Senior anaesthesiologist
will intervene.

12. 12
After obtaining approval from ethical Committee
o 200 patients will be recruited by continuous sampling after satisfying criteria for
selection. Informed consent will be obtained.
o All performers of the SAB, will be given a teaching module on anatomy of spine,
lumbar anatomy and basics of spine scan .
o On day of surgery, patients shifted to procedure room
o Patient in either sitting/lateral position, will be randomised into 2 groups, by sealed
envelope technique.
o In both groups markings will be made on the back of the patient with a skin marker,
by the performer of the SAB
Group LM– Landmark based Group US– USG based
o Subarachnoid block procedure in the OT, according to institutional protocol, after following a pre
procedure checklist.
o Patients in either sitting/lateral position at L2/3 or L3/4 Spinal space with 25 G Quinke tip needle
 Consultant Anaesthesiologistwill assess the performance of the SAB
Methodology Flow chart

13. 13
5.5.1 INTERVENTIONS/DRUGS USED
Preprocedural USG scan before performance of spinal anaesthesia.
5.5.2 PROCUREMENT OF INVESTIGATIONAL DRUGS,
STORAGE, DISPENSING, ETC.
Not applicable
5.6 STUDY TERMINATION
Study will be terminated after the end of enrolment of the required number of
patients.
6 STUDY VARIABLES
S. No
Name of the dependent /
independent variables
Scale of measurement
(Quantitative /
qualitative)
Descriptive / Inferential
Statistics to be used
1. Incidence of procedural
success in first needle pass
Quantitative Chi Square Test
2. Number of needle passes Quantitative Student t test
3. Number of Attempts Quantitative Student t test
4. Time taken for procedure Quantitative Student t Test
5. Incidence of procedural failure Quantitative Chi square test
6.1 DATA COLLECTION
Data will be collected using predefined data capture form(Appendix I) and then
transferred to a masterchart.The privacy and confidentiality of the patient will be
maintained. All patient identifiable numbers and information will be stripped and
replaced by anonymous numbers.

14. 14
6.2 STATISTICAL METHODS
• Incidence of procedural success within one needle pass in both groups– Chi
square test
• Number of needle passes between both groups – Student t test
• Number of attempts between both the groups – Student t test
• Duration of procedure between both groups – Student t test
• Incidence procedure failure in both groups– Chi square test
7 REFERENCES
1. Levy JH, Islas JA, Ghia JN, Turnbull C. A retrospective study of the incidence and causes of
failed spinal anesthetics in a university hospital. Anesth Analg. 1985 Jul;64(7):705–10.
2. Udani AD, Macario A, Nandagopal K, Tanaka MA, Tanaka PP. Simulation-Based Mastery
Learning with Deliberate Practice Improves Clinical Performance in Spinal Anesthesia.
Anesthesiol Res Pract [Internet]. 2014;2014:e659160
3. Chin KJ, Karmakar MK, Peng P. Ultrasonography of the Adult Thoracic and Lumbar Spine for
Central Neuraxial Blockade: Anesthesiology. 2011 Jun;114(6):1459–85.
4. Weed JT, Taenzer AH, Finkel KJ, Sites BD. Evaluation of pre-procedure ultrasound examination
as a screening tool for difficult spinal anaesthesia*. Anaesthesia. 2011 Oct 1;66(10):925–30.
5. Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided
Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia:
Anesthesia & Analgesia. 2015 Oct;121(4):1089–96.
6. Karmakar MK, Li X, Kwok WH, Ho AM-H, Ngan Kee WD. Sonoanatomy relevant for
ultrasound-guided central neuraxial blocks via the paramedian approach in the lumbar region. Br
J Radiol. 2012 Jul;85(1015):e262–9.
7. Conroy PH, Luyet C, McCartney CJ, McHardy PG. Real-Time Ultrasound-Guided Spinal
Anaesthesia: A Prospective Observational Study of a New Approach. Anesthesiol Res Pract [Inter
net]. 2013;2013:e525818.

15. 15
8 PRELIMINARY WORK DONE ALREADY
Review of Literature, Data Collection proforma (Appendix I) and patient consent
form.
9 ETHICAL ISSUES
Spinal anaesthesia is the standard of care for infraumbilical surgeries, with this study
we want to investigate if a preprocedural ultrasonographic examination will improve
the technique. The study involves geriatric population and covert observation or
recording.
10 INFORMED CONSENT PROCEDURE
Attached Appendix II
11 QUALITY CONTROL
Name of Officer designated by the department for quality control:
Name : Dr T Sivashanmugam
Designation:Head of the Department
Telephone No: 9442505567
E-mail: drsiva95@gmail.com
12 SPONSORSHIPS
Not Applicable

16. 16
13 INVESTIGATORS DECLARATION
This is to certify that the protocol entitled “EFFICACY OF PRE-
PROCEDURAL ULTRASOUND OF LUMBAR SPINE IN IMPROVING
THE PROCEDURAL SKILL OF SUBARACHNOID BLOCK” was
reviewed by us for submission to the SBV Institutional Ethics Committee and
certified that this protocol represents an accurate and complete description of the
proposed research. Wehave read the ICMR guidelines, ICP-GCP
guidelines/CPCSEA guidelines/and other applicable guidelinesand undertake to
ensure that the rights and welfare of the study subjects are protected.
The study will be performed as per the approved protocol only. If any deviation is
warranted, the same will be presented to the ethical committee and permission will
be sought. We assure that the study will be terminated immediately in case of any
unforeseen adverse consequences and we will inform the same to the ethical
committee immediately.

17. 17
APPENDIX I
PROFORMA
EFFICACY OF PRE-PROCEDURAL ULTRASOUND OF LUMBAR SPINE
IN IMPROVING THE PROCEDURAL SKILL OF SUBARACHNOID
BLOCK
Name: ASA physical status:
Age/sex: Co morbidities:
Hospital No: Surgical procedure:
Diagnosis:
Group Allotted: Landmark based group [LM] / USG based group (US)
Anaesthesiologist performing spinal:
Performance assessment of Lumbar puncture for subarachnoid block
1. Successful procedure within first needle pass : yes/no
2. Number of needle passes :
3. Number of attempts :
4. Total time taken for Lumbar puncture :
5. Procedural failure : yes/no
Definitions
1. The number of needle passes - defined as the number of forward advancements
of the spinal needle in a given interspinous space, i.e., withdrawal and redirection
of spinal needle without exiting the skin
2. The number of attempts - defined as the number of times the spinal needle is
withdrawn from the skin and reinserted
3. The time taken to detect CSF – time from first needle insertion till CSF detection.
A maximum of 3 attempts will be allowed for the performer. After 3 attempts, it
will be considered as a procedural failure.

18. 18
APPENDIX II
INFORMATION SHEET TO PARTICIPANTS IN THE RESEARCH PROJECT
Name of the research project:”EFFICACY OF PRE-PROCEDURAL
ULTRASOUND OF LUMBAR SPINE IN IMPROVING THE PROCEDURAL
SKILL OF SUBARACHNOID BLOCK “
We welcome and thank you for having accepted our request to participate in our study.
This sheet contains the details of the study; the possible risks, discomfort and benefits
for the participants are also given.
You can read and understand by yourself; if you wish, we are ready to read and explain
the same to you. If you do not understand anything or if you want any more details we
are ready to provide the details.
INFORMATION TO THE PARTICIPANTS
To evaluate if an ultrasound scan of the spine can improve the performance of
spinal anaesthesia, with an injection in your back. The study is being conducted by,
Dr. P R Arthi, a Post Graduate medical student belonging to Anesthesiology
Department, under the guidance of Prof. Dr. R.V Hemanth Kumar. After satisfying our
selection criteria for this study. You have your own choice to take part in this study. If
you don't wish to participate, you will not be included in this study. Even so you will
continue to receive the medical treatment without prejudice. My responsibilities is to
Cooperate for preoperative checkup. To cooperate while performing the scan and
spinal anaesthesia. Indicate at any point, any discomfort during procedure and there is
benefit results from this study to contribute to medical research and education, and for
improved of patient management. There may be some discomfort at the time of scan or

19. 19
spinal (needle prick in your back), risk of reaction due to anaesthesia and you need not
pay for the treatment. Your participation in this study and your personal details will be
kept confidential and will be maintained. If you are interested to know study’s results
your will be informed. If you want to withdraw from the study you are free to leave
this study anytime.

20. 20
INFORMED CONSENT
I have been informed about the details of the research project “EFFICACY OF PRE-
PROCEDURAL ULTRASOUND OF LUMBAR SPINE IN IMPROVING THE
PROCEDURAL SKILL OF SUBARACHNOID BLOCK “
I _______________________ have been informed about the details of the study in my
own language, and been given opportunity to ask questions and clarify my doubts. I
have understood the details of study, such as the performance of a preprocedural spine
examination before performance of spinal anaesthesia. I know the possible risks and
benefits for me by taking part in the study. I understand that I can withdraw from the
study at any point of time and even then, I will continue to get the medical treatment as
usual. I understand that I will not get any payment for taking part in this study. I will
not object if the results of this study are getting published in any medical journals,
provided my personal identity is not reviewed. I know what I am supposed to do by
taking part in this study and I assure that I will give my full co-operation for this study
Signature/Thumb impression of the participant (Name/Address)
__________________________________
__________________________________
__________________________________
Signature/Thumb impression of the witness (Name/Address)
__________________________________
__________________________________
__________________________________
Name & Signature of the investigator
__________________________________
__________________________________

21. 21
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