THESIS PROTOCOL
FOR
DIPLOMATE OF NATIONAL BOARD
ANAESTHESIOLOGY
COMPARISON BETWEEN ULTRASOUNDGUIDED ANTERIOR
SUPRASCAPULAR NERVE BLOCK AND INTERSCALENE NERVE BLOCK
FOR POSTOPERATIVEANALGESIAAFTER ARTHROSCOPIC SHOULDER
SURGERY- A PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY.
Candidate
Dr. Sandeep Dahiya
MBBS, DA.
DNB Resident
Co-GUIDE CO-GUIDE
Dr. Vivek Gupta Dr. Saloni Paranjape
MBBS, MD MBBS, DNB
Consultant Consultant
Guide
Dr. S. P. Singh
MBBS, MBA, DA, MD, FIAMS, CCST (Anaesthesia UK)
Fellow Adult Critical Care Medicine (John Hopkins School of Medicine USA)
Principal Consultant and Co-Ordinator
Department of Anaesthesiology
Dr B.L.Kapur Memorial Hospital, Pusa Road
New Delhi - 110005
•Shoulder procedures are associated with significant postoperative pain which require
use of opioid for several days.
•Various modalities have been tried for post-operative analgesia like intra-articular
local anesthetics or morphine, intravenous opioids as continuous infusion or patient
controlled analgesia (PCA) , non steroidal anti-inflammatory drugs , brachial plexus
nerve blocks like interscalene, suprascapular, supraclavicular, axillary or a
combination of these.
•Although, 'Multi-modal' analgesic techniques incorporating paracetamol, non-
steroidal anti-inflammatory drugs and tramodol can reduce opioid requirements; but,
opioid consumption remains significantly high.
•Apart from nausea, vomiting, sedation, the opioids can cause nociception-induced
central sensitization and secondary hyperalgesia. (1)
INTRODUCTION
 Ultrasound guided interscalene nerve block is a common technique for
postoperative analgesia in patients undergoing shoulder surgery.(2).
 However, the incidence of hemidiaphgramatic paralysis is 33% - 60% even
with low dose (5-10ml) ultrasound guided interscalene block.(2)
 One method of avoiding diaphragm paresis is performing blocks more distally
along the brachial plexus, and thereby increasing the distance between block
location and the phrenic nerve.
 An example of a block more distal to the Interscalene is Suprascapular block.
 The suprascapular nerve provides sensory contributions to 70% of the joint
capsule in addition to the subacromial bursa, the acromioclavicular joint and the
coracoclavicular ligament.
 Siegenthaler et al. have described a proximal ultrasound-guided selective anterior
suprascapular nerve block within supraclavicular fossa. (7).
 This anterior suprascapular nerve block, without the addition of an axillary nerve
block, has been shown to provide diaphragm-sparing analgesia after total shoulder
arthroplasty .(8)
 This and other similar studies has inspired us to conduct a comparative analysis
between the two blocks (Suprascapular Nerve block and Interscalene Nerve
Block)
REVIEW OF LITERATURE
• Singelyn et al (2004) conducted a prospective, randomized, blinded study
to compare analgesic efficacy after arthroscopic shoulder surgery following
intraarticular analgesia (IA), suprascapular nerve block (SSB), and
interscalene brachial plexus block (ISB).
• No significant difference was observed between the IA and control groups,
whereas Groups SSB and ISB had significantly lower pain scores.
• At 4-h follow-up, better pain relief on movement was noted in Group ISB
than in Group SSB.
• They concluded that ISB is the most efficient analgesic technique after
arthroscopic acromioplasty. SSB block would be a clinically appropriate
alternative. (9.)
• Reference : Singelyn, FJ, Lhotel, L, Fabre, B; Pain relief after arthroscopic shoulder surgery: A comparison of
intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg 2004;
99:589–92
 Sang Mook Lee et al (2012) investigated on 61 patients who underwent
arthrocopic rotator cuff repair, in three groups: PCA ( patient controlled analgesia)
only, PCA with ISB (Interscalene block) and PCA with SSB+ANB(Suprascapular
Block + Axillary Nerve Block).
 They found VAS score as:
PCA only group: Highest.
PCA with ISB group: Lowest but with higher fluctuations.
PCA with SSB + ANB: Between other two groups but without any
fluctuation.
 It was summed that PCA with SSB + ANB is better anesthetic choice during initial
24 hours after surgery.
 Reference : Lee SM, Park SE, Nam YS. Analgesic effectiveness of nerve block in shoulder arthroscopy: Comparison
between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012;20:2573–8.
 Nibedita Pani et al (2019) compared inter-scalene block and shoulder block
for post-operative analgesia after shoulder arthroscopic surgery.
 They included 76 patients, divided into 2 groups:- ISB (Interscalene Block)
and SHB (which includes suprascapular block along with axillary nerve block)
group.
 Both the nerve blocks were achieved by using ultrasound and a nerve
stimulator.
 They concluded that SHB is as effective as ISB for post-operative pain relief
and with fewer complications due to selective blockade of suprascapular and
axillary nerves.
 Reference: Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia
for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder
block. Indian J Anaesth. 2019;63(5):382–387.
 PRIMARY AIM: To study and compare the analgesic effects of
ultrasound guided anterior suprascapular nerve block and interscalene
nerve block after arthroscopic shoulder surgery, precisely defined in
terms of pain relief, quality, duration and overall patient satisfaction.
 SECONDARY AIMS: To study and compare the motor block at the
wrist and hand, if any.
-Time to first rescue analgesia.
- Motor weakness in wirst / hand.
-Presence of post-operative subjective dyspnea, if any.
AIMS & OBJECTIVES:
The sample size is calculated on the basis of the primary objective for a
non-inferiority margin of 1:10, estimated rate of incomplete NRS
Questionaire of 10 %, significance of 5%, and study power of 90 %.
The treatment will be given to patients after random allocation of patients
to interscalene group and suprascapular group each.
Total of 62 patients will be included in research, 31 in each group after
random allocation.
The sample size calculated with the formula of sample size calculation of
randomised control trial for non inferiority trial given below.
Statistical Analysis (Sample Size):
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MT Anticipated mean difference in
Test group (post - pre)
2.1
MC Anticipated mean in Control
group (post - pre)
0.5
α Standard Deviation 2
1-α Set level of confidence (usual
value >0.9)
0.95
1-B Set level of power (usual value
>0.7)
0.9 Power of study is 90%
D Absolute Difference P1-P2 1.6
δ Non-inferiority margin 0.1
Z1 Z associated with Confidence 1.644853627
Z2 Z associated with power 1.281551566
r Ratio of subjects in control to
test group
1
N Minimum number of subjects
in Test Group
31 31+31 = 62, this is final sample size
according to study by Asuka
Desroches
Los Angeles, California, April 2015
N1 Minimum number of subjects
in Control Group
31
FORMULA USED :
n= (1+r) * (Z1-α + Z1-α)2 * σ2
r ((MT - MC)-δ)2
The quantitative variables in both groups Group ISB and
Group SSB will be expressed as mean +/- stimulation SD and
compared using unpaired t-test between groups and paired t-
test within each group at various follow-ups.
The Qualitative variables will be expressed as
Frequencies/Percentages and compared using Chi-square test.
A p-value<0.05 will be consider statistically significant.
Statistical Package for Social sciences (SPSS) version 16.0 will
be used for statistical analysis.
Statistical Analysis:
MATERIALS AND METHODS
• Prospective, Randomized, Comparative, double blind study
• Time frame - 12 months.
• Detailed pre-anaesthetic check-up
• Written informed consent and Obtaining institutional ethical committee approval
. 62 patients satisfying the inclusion-exclusion criteria mentioned below will be
included in this study and divided into two groups, Interscalne nerve block and
Suprascapular nerve block.
- Shoulder Arthroscopic Suregery under general anaesthesia.
- Age 18 years to 60 year old.
- American society of anaesthesiologists grade I – III.
Inclusion Criteria
Exclusion Criteria
1. Patients not willing to give consent.
2. Respiratory disease.
3. Uncontrolled Diabetes Mellitus.
4. Patients on Anti-coagulant and Anti-platelet Drugs.
5. Patients Allergic to Local Anaesthetic and USG Gel.
6. Patients with psychiatric drugs, alcohol and Drug Abuse.
7. Pregnant patients
8. Patients with organ dysfunction.
9. Prior surgery in neck or Infraclavicular/ Suprascapular
fossa.
Group ISB (Interscalene): This group will be administered
Balanced General Anaesthesia followed by Ultrasound
guided Interscalene Nerve Block with 10 ml of 0.25%
Ropivacaine.
Group SSB (Suprascapular): This group will be
administered Balanced General Anaesthesia followed by
Ultrasound guided Anterior Suprascapular Nerve Block with
10 ml of 0.25% Ropivacaine.
Patients will be randomized into two groups of 31 patients each
Group ISB and Group SSB.
Group Allocation
Pre-operative anaesthesia check up
 Continuous monitoring of Heart rate, Non invasive blood pressure, oxygen
saturation and Electrocardiogram.
 Nothing per oral status will be confirmed.
 A detailed history of any major illness or any disease in the past
 General physical examination and systemic examination
 Pain at rest in the operative shoulder will be assessed verbally, recorded
on an 11-point numerical rating scale to the tenths of a unit.
 Patients will be explained about US guided ISB and SSB , its advantages
and complications and consent will be taken.
Anaesthesia Technique
General Anaesthesia will be induced using Injection Fentanyl (2 mcg/kg) i.v. and
Propofol 1-2 mg/kg i.v. Cisatracurium 0.15mg/kg i.v. will be used to facilitate
endotracheal intubation.
Anaesthesia will be maintained with sevoflurane in an oxygen air mixture with FiO2
0.5%.
Each Patient will then receive either interscalene or suprascapular nerve block as per
randomization under ultrasound guidance with a high-frequency linear array
ultrasound transducer (SonoSite) with a 22G 5 cm stimuplex needle.
Blocks will be administered by a senior anaesthesiologist having more than 7 years
experience in ultrasound guided nerve blocks, and will not be involved in the study
thereafter.
For the Group ISB (Interscalene nerve block):
Anterior and middle scalene muscle will be identified lateral to carotid artery.
The brachial plexus will be located between the two scalene muscles. The needle will
be inserted in plane plane and 0.25% ropivacaine 10 ml will be injected after negative
aspiration.
For the Group SSB (Anterior Suprascapular nerve block):
Transducer will be placed parallel to the clavicle to
visualize the subclvian artery. On moving the probe cranio-caudally, the
suprascapular nerve will be identified as a small hypoechoic round structure
diverging posteriorly from the upper trunk of the brachial plexus.
Needle will be inserted in the plane deep to the omohyoid muscle till the tip
is next to the nerve. 10 ml of 0.25% ropivaciane will be injected after
negative aspiration.
For the Group SSB (Anterior Suprascapular nerve block):
Observations:
1) Numeric rating score before nerve block at rest and on movement of limb.
2) Numeric rating score after nerve block at 1, 2, 6, 12 and 24 hours after surgery.
3) Time for first rescue analgesia.
4) Patient's satisfaction score: 1- Good
2- Satisfactory
3- Poor
5) Adverse effect like;
-Vomiting
-Nausea
-Pruritis
-Subjective dyspnoea
-Motor block (weak wrist grip)
Sensory block
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STUDY PROFORMA
Sl. No.......... Date-.............
Name of Patient.………………………………………………………………………
Age…… (Years)​ Sex …..(M/F) M.R.D. No…………………..
Weight………….. (in Kg) ASA Grading….…………..
Pre-Operative Diagnosis …………................. Planned Surgery……………
Any Co-morbidity ……………………..
Time of Induction……................. Time for giving SSB/ISB Block……
Time of Intubation ………… Time of Incision………………
Time of Extubation…………
General Anaesthesia Drugs:
Propofol (mg)……………​ Fentanyl (mcg)……………
Cis- Atracurium (mg)…….. ​​ Myopyrrolate………..
Paracetamol (mg)………
Ephedrine......................... Atropine............................
Total dose of intraoperative Fentanyl.......................
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TIME PULSE
(Per Min)
BLOOD
PRESSURE
(mmHg)
SPO2
(%)
DOSE OF
FENTANYL
(mcg)
REMARKS
(if any)
Prior to general
anaesthesia
induction
Pre Block
Post Block
At time of
incision
5 min. post
incision
15 min post
incison
30 min post
incision
At end of surgery
Observations:
Intra-operative :-
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TIME
(hours)
NRS SCORE
(0-10)
PULSE
(Per Min)
BLOOD
PRESSURE
(mmHg)
RESP RATE
(/min)
SPO2
(%)
DOSE OF
FENTANYL
(mcg)
REMARKS
(if any)
1
2
6
12
24
Post-Operative Monitored Parameters
TIME
(hours)
1 2 6 12 24
Vomiting
Nausea
Pruritis
subjective Dyspnea
Motor Block (Wrist
grip)
Sensory Block
Side Effect
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Numeric Rating Scale (NRS) on 0-10 scale
Poor (3) Satisfactory (2) Good (1)
Patient Satisfaction Score
PATIENT INFORMATION SHEET
Study Title: Comparison between Ultrasound Guided Anterior Suprascapular Nerve Block and Interscalene Nerve Block for Postoperative Analgesia
after Arthroscopic Shoulder Surgery: A Prospective Randomized Double Blind Study.
Study Site​: Dr. B. L. Kapur Memorial Hospital Pusa Road, New Delhi-110005.
Principal Investigator of the study: Dr. Sandeep Dahiya
Information Leaflet​​: You are invited to take part in a research project whose aim is to compare the better nerve blocks between ultrasound guided
Anterior Suprascapular Nerve Block and Interscalene Nerve Block in an post-operative Analgesia for patients who had underwent Arthroscopic
shoulder surgery.
Note: Before you decide whether or not to take part, it is important for you to understand the importance of this study and what it will involve.
Please take time to read this information sheet carefully and discuss it with family or friends if you wish so. You are requested to contact the
investigator for more information (see the contact details at the end of this information sheet). Thanks for your participation.
Aim of the study:
The aim of the study is to compare the analgesic effects of ultrasound guided anterior suprascapular nerve block and interscalene nerve block after
arthroscopic shoulder surgery, defined, in terms of pain relief, quality, duration, anti-emetic effects, sedation score and overall patient
satisfaction etc.
What harm it may do?
Respiratory complication leading to desaturation, cardiovascular side effects viz. hypotension, bradycardia, hypertension, dysrhythmias, and drug
reaction, infection, nausea, vomiting.
What is the study about?
Pain is most common adverse outcome of surgery, which affects the post-surgical morbidity, ambulation and discharge from hospital. Obese
patients have higher incidence of respiratory depression to opioid drugs. Thus, post-operative analgesia plays such a crucial role in such
patients. Use of Ultrasound guided anterior suprascapular and Interscalene block has shown good post-operative pain relief in such
conditions.
Do I have to pay for it?
NO. Nothing extra needs to be paid apart from routine expenditure for surgery. The cost of Ultrasound guided anterior
suprascapular and Interscalene block will be taken care by the Dr B. L. Kapur Memorial Hospital.
How it will be given?
It will be given under ultrasound guidance after general anesthesia has been induced.
Will my participation in the study be kept confidential?
If you agree to participate then all the information regarding you and your health will be kept confidential with the help of the
signal indicator. Researchers assure to keep your information confidential.
Can I refuse?
Participation is entirely voluntary. The results will be published in scientific journals will not reveal your identity.
Is the study safe?
Previous studies have shown that the study drug is safe. Ethics Committee of the institute has given official permission to conduct
this study after evaluating it with the experts in this field.
If you agree to participate, it will help us to understand the scientific facts associated with this drug and blocks. So that it may
help us to improve the quality of care for future patients.
Your Responsibility
1. You shall provide accurate and detailed information of your past medical and treatment history to investigators.
2. If any adverse events occurs after procedure you shall immediately inform the appropriate details to the investigators.
Note: For further information you are requested to contact:
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रोगी सूचना पत्रक
अध्ययन शीर्षक: दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन।
अध्ययन सथि: डॉ बी एि कपूर मेमोररयि अस्पताि, पुसा रोड, नई नदल्ट्िी - 110005
अध्ययन के प्रधान जांचकताष: डॉ संदीप दनिया
सूचना पिक:
आपको इस शोध पररयोजना " दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन। " में भाग
िेने के निए आमंनित नकया जाता िै |
यि तय करने से पििे नक आप भाग िेना चािते िैं या निीं, यि समझना आपके निए मित्वपूणष िै नक यि अध्ययन क्यों नकया जा रिा िै और इसमें क्या शानमि िोगा।
कृ पया इस सूचना पि को ध्यान से पढ़ने के निए समय िें और यनद आप चािें तो पररवार या दोस्तों के साथ चचाष करें। आपसे अनुरोध िै नक अनधक जानकारी के निए जांचकताष से संपकष करें (इस सूचना पि के अंत में संपकष नववरण देखें)। आपकी भागीदारी
के निए धन्यवाद।
अध्ययन का उद्देश्य:
अध्ययन का उद्देश्य दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन नवष ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन। , ननन्रा स्कोर,
एंटी-एमैनटक इफे क्ट्स आनद की शुरुआत और अवनध।
यह क्या नुकसान कर सकता है?
स्वाश सम्बन्धी परेशानी से ऑक्सीजन की कमी होने की ओर अग्रसर िोती िै, कानडषयोवैस्कु िर साइड इफे क्ट्स जैसे िाइपोटेंशन, ब्रैडकानडषया, िाइपरटेंशन, धड़कन में गड़बड़ी िोना, और दवा प्रनतनिया, संिमण, मतिी, उल्ट्टी।
क्या अध्ययन है?
ददष सजषरी का सबसे आम प्रनतकू ि पररणाम िै, जो अस्पताि से सनजषकि नवकृ नत, मित्वाकांक्षा और ननवषिन को प्रभानवत करता िै। मोटे रोनगयों में ओनपयोइड दवाओं से श्वसन अवसाद की उछच घटनाएं िोती िैं। इस प्रकार, ऐसे रोनगयों में
पोस्टऑपरेनटव एनाल्ट्जेनसया एक मित्वपूणष भूनमका ननभाता िै। दूरबीन से कं धे के ऑपरेशन के बाद अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन नवष ब्िॉक से ददष राित प्रदान करने के निए नदखाया गया िै।
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क्या मुझे इसके लिए भुगतान करना है?
निीं। शल्ट्य नचनकत्सा के निए ननयनमत व्यय के अिावा कु ि भी अनतररक्त भुगतान करने की आवश्यकता निीं िै। अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक
और इंटरसेक्िेन नवष ब्िॉक की िागत डॉ बी एि कपूर मेमोररयि अस्पताि की देखभाि की जाएगी।
यह कै से लिया जाएगा?
इसे अल्ट्रासाउंड ननदेनशत नकया जाएगा।
क्या अध्ययन में मेरी भागीिारी गोपनीय रखी जाएगी?
यनद आप भाग िेने के निए सिमत िैं तो आपके और आपके स्वास््य के बारे में सारी जानकारी नसग्नि सूचक की सिायता से गोपनीय रखी जाएगी। शोधकताष आपकी
जानकारी को गोपनीय रखने का आश्वासन देते िैं।
क्या मैं मना कर सकता हूँ?
भागीदारी पूरी तरि से स्वैनछिक िै। पररणाम वैज्ञाननक पनिकाओं में प्रकानशत िोने पर आपकी पिचान प्रकट निीं करेंगे।
क्या अध्ययन सुरलित है?
नपििे अध्ययनों से पता चिा िै नक अध्ययन दवा सुरनक्षत िै। संस्थान की नैनतकता सनमनत ने इस क्षेि के नवशेर्ज्ञों के साथ मूल्ट्यांकन करने के बाद इस अध्ययन को
आयोनजत करने की आनधकाररक अनुमनत दी िै।
यनद आप भाग िेने के निए सिमत िैं, तो यि िमें इस दवा से जुड़े वैज्ञाननक त्यों को समझने में मदद करे गा, तानक यि भनवष्य के मरीजों के निए देखभाि की गुणवत्ता में
सुधार करने में िमारी मदद कर सके ।
आपका उत्तरिालयत्व
1. आप जांचकताषओं को अपने नचनकत्सा और उपचार इनतिास की सटीक और नवस्तृत जानकारी प्रदान करेंगे।
2. यनद प्रनिया के बाद कोई प्रनतकू ि घटना िोती िै तो आप तुरंत जांचकताषओं को उपयुक्त नववरण सूनचत करेंगे।
अनधक जानकारी के निए आपसे संपकष करने का अनुरोध नकया जाता िै:
INFORMED CONSENT FORM
I .............................................(C/o, S/o, D/o, W/o) ........................................................................
R/o ............................................................................................................................................................
I have been informed that "Comparison between Ultrasound Guided Anterior Suprascapular Nerve Block and
Interscalene Nerve Block for Postoperative Analgesia after Arthroscopic Shoulder Surgery: A Prospective
Randomized Double Blind Study" is being carried out , which will be used to treat me/my relative.
I have been given the chance to discuss the study and ask questions. I consent that the information arriving from
my clinical progress may be used in study. My participation is voluntary.
Dr. Sandeep Dahiya has informed me to my full satisfaction in the language I understand, about the purpose of
treatment. I have been informed about the duration of study and instructions to be followed during the study
period August 2019 to June 2020. I realize that this is being done for the sake of knowing the relative merits of
comparison between post-operative analgesic effects of ultrasound guided anterior suprascapular block and
interscalene block for arthroscopic shoulder surgery and I give full consent for the same.
I have also been explained the side effects of the treatment to be used. I give full consent for being enrolled in the
above study and I reserve my rights to withdraw from study whenever I wish without prejudice.
Signature of patient/ patient's relative witness
........ ...........
Thumb Impression: ........................
Date: .................
Place: ................
Signature of Investigator:
Name: ............
Date: …………..
07/12/17
सूनचत सिमनत प्रपि
मैं...................................................पुि/पुि/पनत्न.......................................................ननवानस……………....................................
....................................................................................मुझे सूनचत नकया गया िै नक "दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए
अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन का मूल्ट्यांकन
नकया जा रिा िै", नजसका उपयोग मेरे / मेरे ररश्तेदार के इिाज के निए नकया जाएगा।
मुझे अध्ययन पर चचाष करने और प्रश्न पूिने का मौका नदया गया िै। मैं सिमनत देता िं नक मेरी उपचार प्रगनत से आने वािी जानकारी का अध्ययन में नकया जा सकता िै।
मेरी भागीदारी स्वैनछिक िै।
डॉ संदीप दनिया ने मुझे मेरी समझने वािी भार्ा में मेरी पूणष संतुनि के निये, उपचार के उद्देश्य और प्रकृ नत के बारे में बताया िै । अध्ययन और ननदेशों की अवनध के बारे में
मुझे सूनचत नकया गया िै। मैं समझता िं नक अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बाद ददष से राित पर अछिा
प्रभाव पड़ता िै। मुझे एिसास िै नक यि ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना को जानने के निए नकया जा रिा िै
और मैं इसके निए पूरी सिमनत देता िं। मुझे इिाज के दुष्प्रभावों को भी समझाया गया िै। मैं उपयुषक्त अध्ययन में दानखिा िेने के निए पूणष सिमनत देता िं और तब भी मैं
पूवाषग्रि के नबना , मैं अध्ययन से वापस िेने के अपने अनधकार सुरनक्षत रखता ि
रोगी / रोगी के सापेक्ष साक्षी िस्ताक्षर
िस्ताक्षर या अंगूठे की िाप ........................ ….....................
नाम ………………………………………... …....................
नदनांक: …............ ..........................
जांचकताष का िस्ताक्षर:
नाम: ................................................. तारीख: …………………………..……….
References
1) Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review
of current techniques. Anaesthesia 2010; 65: 608– 624.
2) Urmey WF, Talts KH, Sharrock NE: One hundred percent incidence of Hemidiaphragmatic paresis associated with
interscalene brachial plexus analgesia as diagnosed by ultrasonography. Anesth Analg 1991; 72:498-503.
3) fMarhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J. Anaesth 2005;
94:7-17.
4) Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW: Suprascapular and Interscalene nerve block for
shoulder surgery: A systemic review and meta-analysis. Anesthesiology 2017; 127:- 1013’998-1013.
5) Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS: A comparison of combined suprascapular and
axillary nerve blocks to interscalene nerve block for analgesia in arthroscopic shoulder surgery: An equivalence
study. Reg Anesth Pain Med 2016; 41:564-71.
6) Tran DQ, Elgueta MF, Aliste J, Finlayson RJ: Diaphragm-sparing nerve blocks for shoulder surgery . Reg Anesth
Pain Med 2017; 42:32-8.
7) Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U: Ultrasound guided
suprascapular nerve block, description of novel supraclavicular approach. Reg Anesth pain Med 2012;37:325-8.
8) Auyong DB, Yuan SC, Choi DS, et al; A Double-Blind Randomized Comparison of Continuous Interscalene,
Supraclavicular, and Suprascapular Blocks for Total Shoulder Arthroplasty Regional Anesthesia & Pain
Medicine 2017;42:302-309.
9) Singelyn, FJ, Lhotel, L, Fabre, B Pain relief after arthroscopic shoulder surgery: A comparison of intraarticular
analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg 2004; 99:589–92
10) Pitombo, PF, Barros, RM, Matos, MA, Módolo, NS Selective suprascapular and axillary nerve block provides
adequate analgesia and minimal motor block: Comparison with interscalene block. Braz J Anesthesiol 2013; 63:45–
51
11) Lee SM, Park SE, Nam YS. Analgesic effectiveness of nerve block in shoulder arthroscopy: Comparison between
interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012;20:2573–8.
12) Kumara AB, Gogia AR, Bajaj JK, Agarwal N. Clinical evaluation of post-operative analgesia comparing
suprascapular nerve block and interscalene brachial plexus block in patients undergoing shoulder arthroscopic
surgery. J Clin Orthop Trauma 2016;7:34-9.
13) Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic
surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019;63(5):382–387.
THANK YOU

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Dr. Sundeep Thesis Protocol PPT

  • 1. THESIS PROTOCOL FOR DIPLOMATE OF NATIONAL BOARD ANAESTHESIOLOGY COMPARISON BETWEEN ULTRASOUNDGUIDED ANTERIOR SUPRASCAPULAR NERVE BLOCK AND INTERSCALENE NERVE BLOCK FOR POSTOPERATIVEANALGESIAAFTER ARTHROSCOPIC SHOULDER SURGERY- A PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY.
  • 2. Candidate Dr. Sandeep Dahiya MBBS, DA. DNB Resident Co-GUIDE CO-GUIDE Dr. Vivek Gupta Dr. Saloni Paranjape MBBS, MD MBBS, DNB Consultant Consultant Guide Dr. S. P. Singh MBBS, MBA, DA, MD, FIAMS, CCST (Anaesthesia UK) Fellow Adult Critical Care Medicine (John Hopkins School of Medicine USA) Principal Consultant and Co-Ordinator Department of Anaesthesiology Dr B.L.Kapur Memorial Hospital, Pusa Road New Delhi - 110005
  • 3. •Shoulder procedures are associated with significant postoperative pain which require use of opioid for several days. •Various modalities have been tried for post-operative analgesia like intra-articular local anesthetics or morphine, intravenous opioids as continuous infusion or patient controlled analgesia (PCA) , non steroidal anti-inflammatory drugs , brachial plexus nerve blocks like interscalene, suprascapular, supraclavicular, axillary or a combination of these. •Although, 'Multi-modal' analgesic techniques incorporating paracetamol, non- steroidal anti-inflammatory drugs and tramodol can reduce opioid requirements; but, opioid consumption remains significantly high. •Apart from nausea, vomiting, sedation, the opioids can cause nociception-induced central sensitization and secondary hyperalgesia. (1) INTRODUCTION
  • 4.  Ultrasound guided interscalene nerve block is a common technique for postoperative analgesia in patients undergoing shoulder surgery.(2).  However, the incidence of hemidiaphgramatic paralysis is 33% - 60% even with low dose (5-10ml) ultrasound guided interscalene block.(2)  One method of avoiding diaphragm paresis is performing blocks more distally along the brachial plexus, and thereby increasing the distance between block location and the phrenic nerve.  An example of a block more distal to the Interscalene is Suprascapular block.
  • 5.  The suprascapular nerve provides sensory contributions to 70% of the joint capsule in addition to the subacromial bursa, the acromioclavicular joint and the coracoclavicular ligament.  Siegenthaler et al. have described a proximal ultrasound-guided selective anterior suprascapular nerve block within supraclavicular fossa. (7).  This anterior suprascapular nerve block, without the addition of an axillary nerve block, has been shown to provide diaphragm-sparing analgesia after total shoulder arthroplasty .(8)  This and other similar studies has inspired us to conduct a comparative analysis between the two blocks (Suprascapular Nerve block and Interscalene Nerve Block)
  • 7. • Singelyn et al (2004) conducted a prospective, randomized, blinded study to compare analgesic efficacy after arthroscopic shoulder surgery following intraarticular analgesia (IA), suprascapular nerve block (SSB), and interscalene brachial plexus block (ISB). • No significant difference was observed between the IA and control groups, whereas Groups SSB and ISB had significantly lower pain scores. • At 4-h follow-up, better pain relief on movement was noted in Group ISB than in Group SSB. • They concluded that ISB is the most efficient analgesic technique after arthroscopic acromioplasty. SSB block would be a clinically appropriate alternative. (9.) • Reference : Singelyn, FJ, Lhotel, L, Fabre, B; Pain relief after arthroscopic shoulder surgery: A comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg 2004; 99:589–92
  • 8.  Sang Mook Lee et al (2012) investigated on 61 patients who underwent arthrocopic rotator cuff repair, in three groups: PCA ( patient controlled analgesia) only, PCA with ISB (Interscalene block) and PCA with SSB+ANB(Suprascapular Block + Axillary Nerve Block).  They found VAS score as: PCA only group: Highest. PCA with ISB group: Lowest but with higher fluctuations. PCA with SSB + ANB: Between other two groups but without any fluctuation.  It was summed that PCA with SSB + ANB is better anesthetic choice during initial 24 hours after surgery.  Reference : Lee SM, Park SE, Nam YS. Analgesic effectiveness of nerve block in shoulder arthroscopy: Comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012;20:2573–8.
  • 9.  Nibedita Pani et al (2019) compared inter-scalene block and shoulder block for post-operative analgesia after shoulder arthroscopic surgery.  They included 76 patients, divided into 2 groups:- ISB (Interscalene Block) and SHB (which includes suprascapular block along with axillary nerve block) group.  Both the nerve blocks were achieved by using ultrasound and a nerve stimulator.  They concluded that SHB is as effective as ISB for post-operative pain relief and with fewer complications due to selective blockade of suprascapular and axillary nerves.  Reference: Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019;63(5):382–387.
  • 10.  PRIMARY AIM: To study and compare the analgesic effects of ultrasound guided anterior suprascapular nerve block and interscalene nerve block after arthroscopic shoulder surgery, precisely defined in terms of pain relief, quality, duration and overall patient satisfaction.  SECONDARY AIMS: To study and compare the motor block at the wrist and hand, if any. -Time to first rescue analgesia. - Motor weakness in wirst / hand. -Presence of post-operative subjective dyspnea, if any. AIMS & OBJECTIVES:
  • 11. The sample size is calculated on the basis of the primary objective for a non-inferiority margin of 1:10, estimated rate of incomplete NRS Questionaire of 10 %, significance of 5%, and study power of 90 %. The treatment will be given to patients after random allocation of patients to interscalene group and suprascapular group each. Total of 62 patients will be included in research, 31 in each group after random allocation. The sample size calculated with the formula of sample size calculation of randomised control trial for non inferiority trial given below. Statistical Analysis (Sample Size):
  • 12. 07/12/17 MT Anticipated mean difference in Test group (post - pre) 2.1 MC Anticipated mean in Control group (post - pre) 0.5 α Standard Deviation 2 1-α Set level of confidence (usual value >0.9) 0.95 1-B Set level of power (usual value >0.7) 0.9 Power of study is 90% D Absolute Difference P1-P2 1.6 δ Non-inferiority margin 0.1 Z1 Z associated with Confidence 1.644853627 Z2 Z associated with power 1.281551566 r Ratio of subjects in control to test group 1 N Minimum number of subjects in Test Group 31 31+31 = 62, this is final sample size according to study by Asuka Desroches Los Angeles, California, April 2015 N1 Minimum number of subjects in Control Group 31 FORMULA USED : n= (1+r) * (Z1-α + Z1-α)2 * σ2 r ((MT - MC)-δ)2
  • 13. The quantitative variables in both groups Group ISB and Group SSB will be expressed as mean +/- stimulation SD and compared using unpaired t-test between groups and paired t- test within each group at various follow-ups. The Qualitative variables will be expressed as Frequencies/Percentages and compared using Chi-square test. A p-value<0.05 will be consider statistically significant. Statistical Package for Social sciences (SPSS) version 16.0 will be used for statistical analysis. Statistical Analysis:
  • 14. MATERIALS AND METHODS • Prospective, Randomized, Comparative, double blind study • Time frame - 12 months. • Detailed pre-anaesthetic check-up • Written informed consent and Obtaining institutional ethical committee approval . 62 patients satisfying the inclusion-exclusion criteria mentioned below will be included in this study and divided into two groups, Interscalne nerve block and Suprascapular nerve block.
  • 15. - Shoulder Arthroscopic Suregery under general anaesthesia. - Age 18 years to 60 year old. - American society of anaesthesiologists grade I – III. Inclusion Criteria
  • 16. Exclusion Criteria 1. Patients not willing to give consent. 2. Respiratory disease. 3. Uncontrolled Diabetes Mellitus. 4. Patients on Anti-coagulant and Anti-platelet Drugs. 5. Patients Allergic to Local Anaesthetic and USG Gel. 6. Patients with psychiatric drugs, alcohol and Drug Abuse. 7. Pregnant patients 8. Patients with organ dysfunction. 9. Prior surgery in neck or Infraclavicular/ Suprascapular fossa.
  • 17. Group ISB (Interscalene): This group will be administered Balanced General Anaesthesia followed by Ultrasound guided Interscalene Nerve Block with 10 ml of 0.25% Ropivacaine. Group SSB (Suprascapular): This group will be administered Balanced General Anaesthesia followed by Ultrasound guided Anterior Suprascapular Nerve Block with 10 ml of 0.25% Ropivacaine. Patients will be randomized into two groups of 31 patients each Group ISB and Group SSB. Group Allocation
  • 18. Pre-operative anaesthesia check up  Continuous monitoring of Heart rate, Non invasive blood pressure, oxygen saturation and Electrocardiogram.  Nothing per oral status will be confirmed.  A detailed history of any major illness or any disease in the past  General physical examination and systemic examination  Pain at rest in the operative shoulder will be assessed verbally, recorded on an 11-point numerical rating scale to the tenths of a unit.  Patients will be explained about US guided ISB and SSB , its advantages and complications and consent will be taken.
  • 19. Anaesthesia Technique General Anaesthesia will be induced using Injection Fentanyl (2 mcg/kg) i.v. and Propofol 1-2 mg/kg i.v. Cisatracurium 0.15mg/kg i.v. will be used to facilitate endotracheal intubation. Anaesthesia will be maintained with sevoflurane in an oxygen air mixture with FiO2 0.5%. Each Patient will then receive either interscalene or suprascapular nerve block as per randomization under ultrasound guidance with a high-frequency linear array ultrasound transducer (SonoSite) with a 22G 5 cm stimuplex needle. Blocks will be administered by a senior anaesthesiologist having more than 7 years experience in ultrasound guided nerve blocks, and will not be involved in the study thereafter.
  • 20. For the Group ISB (Interscalene nerve block): Anterior and middle scalene muscle will be identified lateral to carotid artery. The brachial plexus will be located between the two scalene muscles. The needle will be inserted in plane plane and 0.25% ropivacaine 10 ml will be injected after negative aspiration.
  • 21. For the Group SSB (Anterior Suprascapular nerve block): Transducer will be placed parallel to the clavicle to visualize the subclvian artery. On moving the probe cranio-caudally, the suprascapular nerve will be identified as a small hypoechoic round structure diverging posteriorly from the upper trunk of the brachial plexus. Needle will be inserted in the plane deep to the omohyoid muscle till the tip is next to the nerve. 10 ml of 0.25% ropivaciane will be injected after negative aspiration.
  • 22. For the Group SSB (Anterior Suprascapular nerve block):
  • 23. Observations: 1) Numeric rating score before nerve block at rest and on movement of limb. 2) Numeric rating score after nerve block at 1, 2, 6, 12 and 24 hours after surgery. 3) Time for first rescue analgesia. 4) Patient's satisfaction score: 1- Good 2- Satisfactory 3- Poor 5) Adverse effect like; -Vomiting -Nausea -Pruritis -Subjective dyspnoea -Motor block (weak wrist grip) Sensory block
  • 24. 07/12/17 STUDY PROFORMA Sl. No.......... Date-............. Name of Patient.……………………………………………………………………… Age…… (Years)​ Sex …..(M/F) M.R.D. No………………….. Weight………….. (in Kg) ASA Grading….………….. Pre-Operative Diagnosis …………................. Planned Surgery…………… Any Co-morbidity …………………….. Time of Induction……................. Time for giving SSB/ISB Block…… Time of Intubation ………… Time of Incision……………… Time of Extubation………… General Anaesthesia Drugs: Propofol (mg)……………​ Fentanyl (mcg)…………… Cis- Atracurium (mg)…….. ​​ Myopyrrolate……….. Paracetamol (mg)……… Ephedrine......................... Atropine............................ Total dose of intraoperative Fentanyl.......................
  • 25. 07/12/17 TIME PULSE (Per Min) BLOOD PRESSURE (mmHg) SPO2 (%) DOSE OF FENTANYL (mcg) REMARKS (if any) Prior to general anaesthesia induction Pre Block Post Block At time of incision 5 min. post incision 15 min post incison 30 min post incision At end of surgery Observations: Intra-operative :-
  • 26. 07/12/17 TIME (hours) NRS SCORE (0-10) PULSE (Per Min) BLOOD PRESSURE (mmHg) RESP RATE (/min) SPO2 (%) DOSE OF FENTANYL (mcg) REMARKS (if any) 1 2 6 12 24 Post-Operative Monitored Parameters TIME (hours) 1 2 6 12 24 Vomiting Nausea Pruritis subjective Dyspnea Motor Block (Wrist grip) Sensory Block Side Effect
  • 27. 07/12/17 Numeric Rating Scale (NRS) on 0-10 scale Poor (3) Satisfactory (2) Good (1) Patient Satisfaction Score
  • 28. PATIENT INFORMATION SHEET Study Title: Comparison between Ultrasound Guided Anterior Suprascapular Nerve Block and Interscalene Nerve Block for Postoperative Analgesia after Arthroscopic Shoulder Surgery: A Prospective Randomized Double Blind Study. Study Site​: Dr. B. L. Kapur Memorial Hospital Pusa Road, New Delhi-110005. Principal Investigator of the study: Dr. Sandeep Dahiya Information Leaflet​​: You are invited to take part in a research project whose aim is to compare the better nerve blocks between ultrasound guided Anterior Suprascapular Nerve Block and Interscalene Nerve Block in an post-operative Analgesia for patients who had underwent Arthroscopic shoulder surgery. Note: Before you decide whether or not to take part, it is important for you to understand the importance of this study and what it will involve. Please take time to read this information sheet carefully and discuss it with family or friends if you wish so. You are requested to contact the investigator for more information (see the contact details at the end of this information sheet). Thanks for your participation. Aim of the study: The aim of the study is to compare the analgesic effects of ultrasound guided anterior suprascapular nerve block and interscalene nerve block after arthroscopic shoulder surgery, defined, in terms of pain relief, quality, duration, anti-emetic effects, sedation score and overall patient satisfaction etc. What harm it may do? Respiratory complication leading to desaturation, cardiovascular side effects viz. hypotension, bradycardia, hypertension, dysrhythmias, and drug reaction, infection, nausea, vomiting. What is the study about? Pain is most common adverse outcome of surgery, which affects the post-surgical morbidity, ambulation and discharge from hospital. Obese patients have higher incidence of respiratory depression to opioid drugs. Thus, post-operative analgesia plays such a crucial role in such patients. Use of Ultrasound guided anterior suprascapular and Interscalene block has shown good post-operative pain relief in such conditions.
  • 29. Do I have to pay for it? NO. Nothing extra needs to be paid apart from routine expenditure for surgery. The cost of Ultrasound guided anterior suprascapular and Interscalene block will be taken care by the Dr B. L. Kapur Memorial Hospital. How it will be given? It will be given under ultrasound guidance after general anesthesia has been induced. Will my participation in the study be kept confidential? If you agree to participate then all the information regarding you and your health will be kept confidential with the help of the signal indicator. Researchers assure to keep your information confidential. Can I refuse? Participation is entirely voluntary. The results will be published in scientific journals will not reveal your identity. Is the study safe? Previous studies have shown that the study drug is safe. Ethics Committee of the institute has given official permission to conduct this study after evaluating it with the experts in this field. If you agree to participate, it will help us to understand the scientific facts associated with this drug and blocks. So that it may help us to improve the quality of care for future patients. Your Responsibility 1. You shall provide accurate and detailed information of your past medical and treatment history to investigators. 2. If any adverse events occurs after procedure you shall immediately inform the appropriate details to the investigators. Note: For further information you are requested to contact:
  • 30. 07/12/17 रोगी सूचना पत्रक अध्ययन शीर्षक: दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन। अध्ययन सथि: डॉ बी एि कपूर मेमोररयि अस्पताि, पुसा रोड, नई नदल्ट्िी - 110005 अध्ययन के प्रधान जांचकताष: डॉ संदीप दनिया सूचना पिक: आपको इस शोध पररयोजना " दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन। " में भाग िेने के निए आमंनित नकया जाता िै | यि तय करने से पििे नक आप भाग िेना चािते िैं या निीं, यि समझना आपके निए मित्वपूणष िै नक यि अध्ययन क्यों नकया जा रिा िै और इसमें क्या शानमि िोगा। कृ पया इस सूचना पि को ध्यान से पढ़ने के निए समय िें और यनद आप चािें तो पररवार या दोस्तों के साथ चचाष करें। आपसे अनुरोध िै नक अनधक जानकारी के निए जांचकताष से संपकष करें (इस सूचना पि के अंत में संपकष नववरण देखें)। आपकी भागीदारी के निए धन्यवाद। अध्ययन का उद्देश्य: अध्ययन का उद्देश्य दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन नवष ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन। , ननन्रा स्कोर, एंटी-एमैनटक इफे क्ट्स आनद की शुरुआत और अवनध। यह क्या नुकसान कर सकता है? स्वाश सम्बन्धी परेशानी से ऑक्सीजन की कमी होने की ओर अग्रसर िोती िै, कानडषयोवैस्कु िर साइड इफे क्ट्स जैसे िाइपोटेंशन, ब्रैडकानडषया, िाइपरटेंशन, धड़कन में गड़बड़ी िोना, और दवा प्रनतनिया, संिमण, मतिी, उल्ट्टी। क्या अध्ययन है? ददष सजषरी का सबसे आम प्रनतकू ि पररणाम िै, जो अस्पताि से सनजषकि नवकृ नत, मित्वाकांक्षा और ननवषिन को प्रभानवत करता िै। मोटे रोनगयों में ओनपयोइड दवाओं से श्वसन अवसाद की उछच घटनाएं िोती िैं। इस प्रकार, ऐसे रोनगयों में पोस्टऑपरेनटव एनाल्ट्जेनसया एक मित्वपूणष भूनमका ननभाता िै। दूरबीन से कं धे के ऑपरेशन के बाद अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन नवष ब्िॉक से ददष राित प्रदान करने के निए नदखाया गया िै।
  • 31. 07/12/17 क्या मुझे इसके लिए भुगतान करना है? निीं। शल्ट्य नचनकत्सा के निए ननयनमत व्यय के अिावा कु ि भी अनतररक्त भुगतान करने की आवश्यकता निीं िै। अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन नवष ब्िॉक की िागत डॉ बी एि कपूर मेमोररयि अस्पताि की देखभाि की जाएगी। यह कै से लिया जाएगा? इसे अल्ट्रासाउंड ननदेनशत नकया जाएगा। क्या अध्ययन में मेरी भागीिारी गोपनीय रखी जाएगी? यनद आप भाग िेने के निए सिमत िैं तो आपके और आपके स्वास््य के बारे में सारी जानकारी नसग्नि सूचक की सिायता से गोपनीय रखी जाएगी। शोधकताष आपकी जानकारी को गोपनीय रखने का आश्वासन देते िैं। क्या मैं मना कर सकता हूँ? भागीदारी पूरी तरि से स्वैनछिक िै। पररणाम वैज्ञाननक पनिकाओं में प्रकानशत िोने पर आपकी पिचान प्रकट निीं करेंगे। क्या अध्ययन सुरलित है? नपििे अध्ययनों से पता चिा िै नक अध्ययन दवा सुरनक्षत िै। संस्थान की नैनतकता सनमनत ने इस क्षेि के नवशेर्ज्ञों के साथ मूल्ट्यांकन करने के बाद इस अध्ययन को आयोनजत करने की आनधकाररक अनुमनत दी िै। यनद आप भाग िेने के निए सिमत िैं, तो यि िमें इस दवा से जुड़े वैज्ञाननक त्यों को समझने में मदद करे गा, तानक यि भनवष्य के मरीजों के निए देखभाि की गुणवत्ता में सुधार करने में िमारी मदद कर सके । आपका उत्तरिालयत्व 1. आप जांचकताषओं को अपने नचनकत्सा और उपचार इनतिास की सटीक और नवस्तृत जानकारी प्रदान करेंगे। 2. यनद प्रनिया के बाद कोई प्रनतकू ि घटना िोती िै तो आप तुरंत जांचकताषओं को उपयुक्त नववरण सूनचत करेंगे। अनधक जानकारी के निए आपसे संपकष करने का अनुरोध नकया जाता िै:
  • 32. INFORMED CONSENT FORM I .............................................(C/o, S/o, D/o, W/o) ........................................................................ R/o ............................................................................................................................................................ I have been informed that "Comparison between Ultrasound Guided Anterior Suprascapular Nerve Block and Interscalene Nerve Block for Postoperative Analgesia after Arthroscopic Shoulder Surgery: A Prospective Randomized Double Blind Study" is being carried out , which will be used to treat me/my relative. I have been given the chance to discuss the study and ask questions. I consent that the information arriving from my clinical progress may be used in study. My participation is voluntary. Dr. Sandeep Dahiya has informed me to my full satisfaction in the language I understand, about the purpose of treatment. I have been informed about the duration of study and instructions to be followed during the study period August 2019 to June 2020. I realize that this is being done for the sake of knowing the relative merits of comparison between post-operative analgesic effects of ultrasound guided anterior suprascapular block and interscalene block for arthroscopic shoulder surgery and I give full consent for the same. I have also been explained the side effects of the treatment to be used. I give full consent for being enrolled in the above study and I reserve my rights to withdraw from study whenever I wish without prejudice. Signature of patient/ patient's relative witness ........ ........... Thumb Impression: ........................ Date: ................. Place: ................ Signature of Investigator: Name: ............ Date: …………..
  • 33. 07/12/17 सूनचत सिमनत प्रपि मैं...................................................पुि/पुि/पनत्न.......................................................ननवानस…………….................................... ....................................................................................मुझे सूनचत नकया गया िै नक "दूरबीन से कं धे के ऑपरेशन के बाद ददष ननवारण के निए अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना - एक संभानवत यादृनछिक दोनों अनजान अध्ययन का मूल्ट्यांकन नकया जा रिा िै", नजसका उपयोग मेरे / मेरे ररश्तेदार के इिाज के निए नकया जाएगा। मुझे अध्ययन पर चचाष करने और प्रश्न पूिने का मौका नदया गया िै। मैं सिमनत देता िं नक मेरी उपचार प्रगनत से आने वािी जानकारी का अध्ययन में नकया जा सकता िै। मेरी भागीदारी स्वैनछिक िै। डॉ संदीप दनिया ने मुझे मेरी समझने वािी भार्ा में मेरी पूणष संतुनि के निये, उपचार के उद्देश्य और प्रकृ नत के बारे में बताया िै । अध्ययन और ननदेशों की अवनध के बारे में मुझे सूनचत नकया गया िै। मैं समझता िं नक अल्ट्रासाउंड ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बाद ददष से राित पर अछिा प्रभाव पड़ता िै। मुझे एिसास िै नक यि ननदेनशत पूवषकाि सुप्रास्कै पुिर तंनिका ब्िॉक और इंटरसेक्िेन तंनिका ब्िॉक के बीच तुिना को जानने के निए नकया जा रिा िै और मैं इसके निए पूरी सिमनत देता िं। मुझे इिाज के दुष्प्रभावों को भी समझाया गया िै। मैं उपयुषक्त अध्ययन में दानखिा िेने के निए पूणष सिमनत देता िं और तब भी मैं पूवाषग्रि के नबना , मैं अध्ययन से वापस िेने के अपने अनधकार सुरनक्षत रखता ि रोगी / रोगी के सापेक्ष साक्षी िस्ताक्षर िस्ताक्षर या अंगूठे की िाप ........................ …..................... नाम ………………………………………... ….................... नदनांक: …............ .......................... जांचकताष का िस्ताक्षर: नाम: ................................................. तारीख: …………………………..……….
  • 34. References 1) Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia 2010; 65: 608– 624. 2) Urmey WF, Talts KH, Sharrock NE: One hundred percent incidence of Hemidiaphragmatic paresis associated with interscalene brachial plexus analgesia as diagnosed by ultrasonography. Anesth Analg 1991; 72:498-503. 3) fMarhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J. Anaesth 2005; 94:7-17. 4) Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW: Suprascapular and Interscalene nerve block for shoulder surgery: A systemic review and meta-analysis. Anesthesiology 2017; 127:- 1013’998-1013. 5) Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS: A comparison of combined suprascapular and axillary nerve blocks to interscalene nerve block for analgesia in arthroscopic shoulder surgery: An equivalence study. Reg Anesth Pain Med 2016; 41:564-71. 6) Tran DQ, Elgueta MF, Aliste J, Finlayson RJ: Diaphragm-sparing nerve blocks for shoulder surgery . Reg Anesth Pain Med 2017; 42:32-8. 7) Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U: Ultrasound guided suprascapular nerve block, description of novel supraclavicular approach. Reg Anesth pain Med 2012;37:325-8. 8) Auyong DB, Yuan SC, Choi DS, et al; A Double-Blind Randomized Comparison of Continuous Interscalene, Supraclavicular, and Suprascapular Blocks for Total Shoulder Arthroplasty Regional Anesthesia & Pain Medicine 2017;42:302-309. 9) Singelyn, FJ, Lhotel, L, Fabre, B Pain relief after arthroscopic shoulder surgery: A comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg 2004; 99:589–92 10) Pitombo, PF, Barros, RM, Matos, MA, Módolo, NS Selective suprascapular and axillary nerve block provides adequate analgesia and minimal motor block: Comparison with interscalene block. Braz J Anesthesiol 2013; 63:45– 51 11) Lee SM, Park SE, Nam YS. Analgesic effectiveness of nerve block in shoulder arthroscopy: Comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012;20:2573–8. 12) Kumara AB, Gogia AR, Bajaj JK, Agarwal N. Clinical evaluation of post-operative analgesia comparing suprascapular nerve block and interscalene brachial plexus block in patients undergoing shoulder arthroscopic surgery. J Clin Orthop Trauma 2016;7:34-9. 13) Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019;63(5):382–387.