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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 AD MISSION | MAY/2016 YR OF

EXAMINATION

M.D ANAESTHESIOLOGY, MGMCRI

GUIDE

DR . V R HEMANTH KUMAR

PROF ES SOR

DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI

Co-GUIDE

DR . ARCHANA ARETI

SENIO R RESIDENT


Co-GUIDE

DR . V JAYA

ASSISSTANT P ROFE SSOR


MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

2

CANDIDATE

Candidate Name :Dr. P R Arthi

Course of Study : MD ANAESTHESIOLOGY

University Identity No : 1601021003

Mobile Phone No : +919487547071

E-mail Address : [email protected]

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

[email protected]

CO GUIDE: DR. ARCHANA ARETI

Senior Resident


8374237095

[email protected]

CO GUIDE: DR.V JAYA

Assistant Professor


9843804054

[email protected]

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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.

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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

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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

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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

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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

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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.

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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

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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.

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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

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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.

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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.

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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: [email protected]

12 SPONSORSHIPS

Not Applicable

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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.

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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.

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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

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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.

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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

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