SUBMISSION OF THESIS PROTOCOL FOR THE AWARD OF

DEGREE
M.D. (ANAESTHESIA)
NIMS UNIVERSITY
National Institute of Medical Science and
Research, Jaipur (Rajasthan)

• TITLE- “COMPARISON OF INTRATHECAL MORPHINE AND ADDUCTOR

CANAL BLOCK WITH MULTIMODAL ANALGESIA (GABAPENTIN AND
NSAIDs) FOR ANALGESIA AMBULATION, ADVERSE EFFECTS AND PATIENT
SATISFACTION AFTER TOTAL KNEE REPLACEMENT(TKR) SURGERY”
CANDIDATE NAME: GUIDE:
DR. PRIYANKA DAGAR DR. AJAY VIKRAM SINGH
PROFESSOR
(DEPTT.OF ANAESTHESIA)
 Name Of The Candidate DR. PRIYANKA DAGAR

Name Of The Department ANAESTHESIA

NATIONAL INSTITUTE OF MEDICAL

Name Of The Institution
SCIENCES AND RESEARCH, JAIPUR

Course Of Study And Subject M.D. ANAESTHESIA

Date Of Admission To Course 2/11/2022
DR. AJAY VIKRAM SINGH
Name Of Guide
PROFESSOR
DR. PREETI SAINI
Name Of Co-Guide
ASSISTANT PROFESSOR
COMPARISON OF INTRATHECAL
MORPHINE AND ADDUCTOR CANAL
BLOCK WITH MULTIMODAL
ANALGESIA (GABAPENTIN AND
Title
NSAIDs) FOR ANALGESIA
AMBULATION, ADVERSE EFFECTS AND
PATIENT SATISFACTION AFTER TOTAL
KNEE REPLACEMENT(TKR) SURGERY
 AIM

• To compare the effects of intrathecal morphine

and adductor canal block combined with
multimodal analgesia for pain relief after knee
replacement surgery
 OBJECTIVES

1. PRIMARY
A . Onset of sensory & motor blockade
B .Duration of sensory & motor blockade
2. SECONDARY
Patient satisfaction and post operative ambulation
and pain management
 MATERIALS AND METHODS

STUDY DESIGN:
Randomised observational comparative study.

STUDY AREA:
The study will be conducted in Department Of
Anaesthesiology, National Institute Of Medical
Sciences And Research, Jaipur
Statistical analysis:
After collecting data, appropriate statistics will be used to
analyse data. all statistical analysis will be performed in
SPSS/ Microsoft excel.

Time frame:
18 months

Study Period:
1 May2023 to Nov.2024(18 months)
Sampling Technique:
Systemic Random Sampling Technique

Sample Size:
n = [ Zα/2 + Z 1-β]2*[(p1*(1-p1)+p2*(1-p2)]/ (p2-p1) 2
= [1.96+0.84]2*[(0.375*(1-0.375) + 0.125*(1-0.125) (0.125-0.375) 2

43.12 ~43~ sample /group

• Zα/2: :inversenormalprobabilityat95% confidenceinterval
• Z 1-β :inversenormalprobability80%powerofthetest
• p1 & p2 :proportionrateofnopainpatientsafter24hrsinadductorcanalblockandnoblockgroups.
 SELECTION CRITERIA OF PATIENTS

INCLUSION CRITERIA:
• ASA grade I and II patients.
• AGE 45 to 75 years of either sex.
• BMI of 18 to 30 is considered.
• Patient willing to sign informed consent.
• Patient scheduled for unilateral TKR surgery.
EXCLUSION CRITERIA:
• Patient allergic to any drugs.
• Contraindication to neuraxial block.
• Patients with renal hepatic, cardiovascular
diseases.
• Patient for bilateral TKR surgeries.
 METHODOLOGY
Permission from scientific and Ethics committee

Patients selection based on inclusion an exclusion criteria

Informed written consent from patient/relatives

Pre-Anaesthetic check-up with screening tests

Intra-Operative monitoring

Premedication and Induction

Statistical analysis interpretation of data

PRE-ANAESTHETIC CHECK-UP:
• It will be done a day before surgery.
• Informed written consent for procedure and future
use of data for publication.
• Detailed complete history of patient.
• Weight and height of the patient.
• Vitals-Blood Pressure, Respiratory Rate, Heart
Rate, Spo2.
• Detailed systemic examination
• Airway Examination.
• NBM
CONSENT:
The procedure will be explained to the patient and
relatives than written informed consent will be
taken.

INVESTIGATIONS:
• All routine investigations.
• Chest X-ray.
• ECG. 2D ECHO if indicated
• Patient will be kept fasting for 6 hours before
surgery.
• On arrival of patient in the operating room
standard monitoring will be applied; ECG, Pulse
Oximetry, NIBP.
• 20-gauge & 18 gauge intravenous cannula will be
secured.
• The randomised study shall be conducted
following institutional ethics committee approval
wherein total 86 patients will be classified into two
groups 43 patients in each group.
Group M Inj.Bupivacaine 0.5% with
Inj.Morphine(0.2 mg)

Group Inj.Bupivacaine with Adductor

A canal block and NSAIDs.
DRUGS REQUIRED:

• A. STUDY DRUG - Inj. Bupivacaine .5%,

Inj.Ropivacaine .25%, Gabapentin, NSAIDs, Etoricoxib.
• B. EMERGENCY DRUGS - Inj. Atropine, Inj.
Adrenaline, Inj. Mephentermine, Inj. Dopamine, Inj.
Pheniramine, Inj. Furosemide, Inj. Epinephrine, Inj.
Antihistaminic, Inj. Metoclopramide, Inj. Ranitidine, Inj.
Calcium gluconate, Inj. Noradrenaline, Inj. Sodium
bicarbonate Inj. Naloxone, Inj. Isoprinosine, Inj.
Hydrocortisone, Inj. Dexamethasone, Inj. Dobutamine,
Inj. Amiodarone
TECHNIQUES:
• This hospital-based prospective randomized observational
comparative study will be conducted in our institute from
May 2023 to Nov 2024 after obtaining permission from the
institutional ethics committee and after registering in the
Clinical Trials Registry-India.
• All patients who will give written informed consent will be
included in the study.
• Randomization will be done by systemic randomization
technique.
• Concealment of randomization will performed through the
sealed envelope method.
• 86 patients will randomly divided into two groups of 43 each
.
 INTRODUCTION
• Knee arthroplasty is a surgical procedure that involves
the reconstruction or replacement of a damaged joint.
It is often performed to relieve pain and improve
mobility in joints that have been affected by arthritis ,
injury or other conditions. Extent of pain in patients
being prepared for arthroscopic surgeries is moderate
to severe , difficulty in walking which makes patient
less mobilize that creates more complications for the
patient. The amount of pain patient experiences during
arthroscopy can vary depending on factors such as the
type of procedure being performed and patient’s
individual pain tolerance1.
• So pain management is an important aspect of
knee arthroscopy as generally seen arthroscopy
procedures are done under spinal anesthesia
which have potential to provide excellent
operating conditions and prolong post
operative pain relief. Several approaches are
taken for pain management which is important
aspect of knee arthroscopy includes
intracthecal morphine and one more newer
approach that is adductor canal block 2.
• Intrathecal morphine is a method of delivering
pain relief medication directly around spinal
cord. As it does comes with some risks and
potential side effects. These include nausea,
vomiting, itching, respiratory depression and
even seizures or coma in rare cases so may
require proper supervision and monitoring 3.
• Regional anesthesia and analgesia has the
potential to provide excellent operating
conditioned and prolong post operative
morbidity and mortality by its positive
influence like improved blood flow and
optimum tissue functionality and improved
recovery, thereby leading to its widespread use.
Additives like opioids that are used in
combination such a NSAIDs can provide better
analgesia and can also increase the risk of side
effects such as sedation ,respiratory depression
and constipation4.
• Newer technique known as adductor canal
block had better pain relief and more effective
ambulation and provides good post operative
analgesia and significantly better quadriceps
muscle strength compared to others. As these
patients are usually having comorbidities as
they are older patients particularly at risk like
obesity ,DVT, persistent pain or stiffness5.
 RESEARCH QUESTION
• Whether post operative analgesia ambulation
and patient satisfaction is better in intrathecal
morphine with bupivacaine or Inj.Bupivacaine
with Adductor canal block and NSAIDs in post
operative TKR patients.?

RESEARCH HYPOTHESIS
• Post operative analgesia ambulation and patient
satisfaction after TKR surgery is similar with added
morphine and adductor canal block with multimodal
analgesia.
 REVIEW OF LITERATURE
• Sophit Lhoawchai (2020) studied that ACB is a peripheral
nerve blockade technique that provide good pain control ,
particularly pain during movement in patients undergoing TKA
when combined with intrathecal morphine as multimodal
analgesia.
• Per Essving (2011) studied that LIA technique provided better
postoperative analgesia and earlier mobilization resulting in
shorter hospital stay than did intrhecal morphine after TKA.
• Wirinare Kmpitak(2017) studied that combined ACB and LIA
enhanced early ambulation with reduced and delayed rescue
analgesia.
• Rakhee goyal (2017) studied that addition dexmedetomidine
to ropivacaine results in longer duration of analhgesia after
adductor canal block for simultaneous bilateral total knee
replacement surgery.
 REFERENCE
1. Bong MR, Di Cesare PE. Stiffness after total knee arthroplasty. J Am Acad
Orthop Surg 2004;12:164-71.
2. Ragucci MV, Leali A, Moroz A, Fetto J. Comprehensive deep venous
thrombosis prevention strategy after total-knee arthroplasty. Am J Phys Med
Rehabil 2003;82:164-8.
3. Puolakka PA, Rorarius MG, Roviola M, et al. Persistent pressure
following knee arthroplasty. Eur J Anaesthesiol 2010;27: 455-60.
4. Paul JE, Arya A, Hurlburt L, et al. femoral nerve block improves
analgesia outcomes after total knee arthroplasty: a meta-analysis of
randomized controlled trials. Anesthesiology 2010;113:1144-62.
5. Ilfeld BM, Duke KB, Donohue MC. The association between lower
extremity continuous peripheral nerve blocks and patient falls after knee and
hip arthroplasty. Anesth Analg 2010;111:1552-4.
 CASE PROFORMA
• Name of the patient:
• Reg. No.:
• Age:
• Gender:
• Height:
• weight:
• ASA Grade:
• Pre-operative Diagnosis:
• Proposed surgery:
• Anaesthesiologist:
• Surgeon:
GENERAL PHYSICAL EXAMINATION
• Temperature

• Pallor
• Cyanosis

• Icterus

• Lymphadenopathy
• Pedal edema

• Pulse rate
• BP
• RR
• Pedal edema
• AIRWAY EXAMINATION
• Dentures

• MPG
• Mouth opening:
• Neck movement:
• SYSTEMIC EXAMINATION
• Central nervous system

• Abdomen
• Cardiothoracic system

• Respiratory system
• PREOPERATIVE INVESTIGATIONS
• Hb (gm. %)
• TLC
• DLC
• Platelet Count
• Blood Sugar (F)
• BUN/S. Creatinine
• S. Urea
• SGOT/SGPT
• Bilirubin
• BT
• CT
• PT -INR
• CXR
• ECG
• Relevant specific investigations:
TIME OF INDUCTION
• Time of sensory & motor blockade
• Onset of sensory and motor blockade
INTRA-OP MONITORING
Parameter
• Heart rate(HR)
• Systolic blood pressure(SBP)
• Diastolic blood pressure(DBP)
• Mean arterial blood pressure(MAP)
• Oxygen saturation( Spo2)
POST OPERATIVE MONITORING
• Duration of sensory and motor blockade
• Pain score at 6, 12,24 hours
• Ambulation time post operative
• Post operative nausea and vomiting.
 PARTICIPANT INFORMED CONSENT FORM
• Protocol/ Study number : _________________________________________________________________
• Participant identification number for this trial : ________________________________________________
Title of Project ‘Randomized Comparison Of Intrathecal Morphine and Adductor Canal Block with Multimodal Analgesia( Gabapentin,
NSAIDs) For Analgesia, Ambulation, Adverse Effects And Patient Satisfaction After TKR”
• Name of the principal investigator: Dr.Priyanka Tel No(s) 9571383410
The contents of the information sheet dated that was provided have been read carefully by me/ explained in detail to me, in a language
that I comprehend and I have fully understood the contents. I confirm that I have had the opportunity to ask questions.

The nature and purpose of the study and its potential risks/ benefits and expected duration of the study and other relevant details of the
study have been explained to me in detail. I understand that my participation is voluntary and that I am free to withdraw at any time, without
giving any reason, without my medical care or legal right being affected.

I understand that the information collected about me from my participation in this research and sections of any of my medical notes
may be looked at by responsible individuals from NIMS Ethics Committee Members/ Regulatory Authorities. I give permission for these
individuals to have access to my records.

I agree to take part in the above study

• Date: ________________
• (Signature/ Left thumb Impression): _______________ Place: ___________
• Name of the participant: _________________________________________________________
• Son/ Daughter/ Spouse of: _______________________________________________________
• Complete postal address: _________________________________________________________

This is to certify that the above consent has been obtained in my presence
• Date: _________________ Place: __________________
• Signature of the Principal Investigator
Witness -1 Witness- 2
• Signature : _____________________ Signature : ______________________
• Name: _________________________ Name: ________________________
• Address: __________________________________ Addres: _______________________________
 PARTICIPANT INFORMATION SHEET
What is the background to and purpose of the study?
“RANDOMIZED COMPARISON OF INTRATHECAL MORPHINE and ADDUCTOR CANAL BLOCK
with MULTIMODAL ANALGESIA ( GABAPENTIN, NSAIDs) FOR ANALGESIA,
AMBULATION,ADVERSE EFFECTS AND PATIENT SATISFACTION AFTER TKR”
• Do I have to take part?
• Yes, because the detailed history and clinical examination is required to
reach the diagnosis and management of the patient.
• What are the possible side-effects, risks and discomforts of taking part?
• There are no side-effects and risk factors and discomforts.
• What are the possible benefits of taking part?
• Early detection and management is possible.
• What if new information becomes available?
• New information will be provided if available
• What are the costs of taking part?
• Free of cost
• How will my personal data be used?
• Maintenance of confidentiality of records as well as Patient information.
• Whom should I contact if I need more information or help?
• Dr. Priyanka Dagar
• Ph no: +91- ________________
 ABSTRACT OF SEED ARTICLE
TITLE
Ultrasound-Guided Single Injection Adductor
Canal Block with Intrathecal Morphine for
Analgesia after Total Knee Arthroplasty

AUTHOR
Sophit Lhoawchai , Chalearmpong Pinupong ,
Uthaiwan Harnyoo , Chatuphorn Boonyuid ,
Saksaran Lamlert.
BACKGROUND:
• Total knee arthroplasty (TKA) is an operation
associated with moderate to severe
postoperative pain.
• Adductor canal block (ACB) is a peripheral
nerve blockade technique that provides good
pain control in patients undergoing TKA when
combined with multimodal analgesia.
METHODS
• We performed a randomized, controlled study of
eighty patients scheduled for TKA with spinal
anesthesia and 0.2 mg of intrathecal morphine.
• After the operation, the patients were randomized
to either the ACB group (ACB with 20 ml of
bupivacaine 0.5% with 1: 200,000 epinephrine) or
the NB group (no block).
• The primary outcome was the comparative
postoperative pain score at rest and during
movement in 6, 12, and 24 hours postoperatively.
Secondary comparative outcomes included
quadriceps and adductor muscle strength, opioid-
related side effects, hospital length of stay, and
patient satisfaction.
RESULTS
• The pain scores at rest and during movement in
6, 12, and 24 hours were no significant
• However, there was a tendency of numbers of
patients with no pain (NRS=0) in the ACB
group than the NB group, especially during
knee motion.
• When controlling the factor of preoperative
quadriceps strength, operation time, and
periarticular block by a surgeon, the results
showed that there were significant differences
in the pain on movement between both groups.
 CONCLUSIONS

 
• ACB is a peripheral nerve blockade technique
that provides good pain control, particularly
pain during movement in patients undergoing
TKA when combined with intrathecal
morphine as multimodal analgesia.
Thank You