PLAN OF DISSERTATION

COMPARISON OF ONSET AND DURATION OF SENSORY

AND MOTOR BLOCKADE BETWEEN INTRATHECAL 0.5%
ISOBARIC BUPIVACAINE WITH 25 MICROGRAMS
FENTANYL AND 0.5% HYPERBARIC BUPIVACAINE WITH
25 MICROGRAMS FENTANYL FOR INFRAUMBILICAL
SURGERIES- A ONE YEAR HOSPITAL BASED
RANDOMISED CONTROLLED TRIAL AT SMS MEDICAL
COLLEGE AND ATTACHED GROUP OF HOSPITALS,
JAIPUR

Submitted to
Rajasthan University of Health Sciences

For the degree of

M.D. (ANAESTHESIOLOGY)

Submitted by
Dr. MADHAVI SINGH
Department of Anaesthesiology,
S.M.S. Medical College,
Jaipur

Under the supervision and guidance of

Dr. SHRIPHAL MEENA
Senior Professor & PHOD
Department of Anaesthesiology,
S.M.S. Medical College,
Jaipur
 INTRODUCTION

Spinal anaesthesia is the most preferred technique of anaesthesia in infraumbilical surgeries.

This is due to the factors like avoiding the risks of general anesthesia such as pulmonary
aspiration, bronchospasm, laryngospasm, cardiovascular response to intubations or risk of
failed intubation. It also provides effective pain relief during intra operative and early
postoperative period.5 Spinal anaesthesia also has rapid onset, safety, reliability and low
failure rate.6

However, regional anesthesia technique have seen numerous modifications over the last
decades with addition of newer anaesthetic agents with adjuvents. Bupivicaine, the most
commonly used local anaesthetic in spinal anaesthesia, available in its isobaric and
hyperbaric form based on its density. The baricity of a solution is the ratio of density of
solution to that of the CSF.

The importance of isobaric is that the distribution of drug is not dependent on the positioning
of the patient during the injection of the drug. For an anaesthetic drug to become hyperbaric,
the baricity should be above 1.0015 at 37 degree Celsius. This can be achieved by adding
dextrose to the solution. For hyperbaric solution the distribution depends on the positioning
of the patient. There is adverse reaction involving Central Nervous System and Cardio-
Vascular System reported with administration of bupivicaine.

The advantages of using adjuvant (Fentanyl) to local anaesthetic, may help in reducing the
dosage of local anaesthetic, reduce adverse effects and prolong the adverse effects of
anaesthesia. The advantages of administration of opioid like fentanyl with local anaesthetic
are to achieve sensory blockade with fewer pulmonary complication, early return of bowel
functions and early discharge from hospital.

The aim of this randomised study is to compare intrathecal isobaric bupivacaine with fentanyl
and hyperbaric bupivacaine with fentanyl for infraumbical surgeries under spinal anaesthesia
to determine their effectiveness in terms of sensory onset, motor onset, sensory regression,
motor regression and total duration of anaesthesia.
 AIM AND OBJECTIVES

AIM
To compare the motor and sensory blockade of intrathecal isobaric bupivacaine with fentanyl
and hyperbaric bupivacaine with fentanyl.

OBJECTIVES
Primary objective
1. Comparison of mean time duration in sensory onset.

1. Comparison of mean time duration in motor onset.

2. Comparison of mean time taken for sensory regression.
3. Comparison of mean time taken for motor regression.
4. Comparison of mean time of total duration of
analgesics

Secondary Objectives

1.Comparison of hemodynamic changes.

2.Study any adverse effects associated with drugs
given.
 HYPOTHESIS

H0 (NULL HYPOTHESIS): There is no significant change in duration and onset of sensory

and motor blockade in isobaric and hyperbaric bupivicaine when given with fentanyl for
infraumbilical surgeries.

H1 (ALTERNATE HYPOTHESIS): There is significant change in duration and onset of

sensory and motor blockade in isobaric and hyperbaric bupivicaine when given with fentanyl
for infraumbilical surgeries.

MATERIAL AND METHODS

STUDY AREA: The study will be conducted in the operation theatres, Department of
Anaesthesiology, S.M.S. Medical College and Associated groups of hospital, Jaipur.

STUDY DESIGN: Hospital-based prospective, randomized interventional study.

STUDY PERIOD: After approval of the Ethical committee till the completion of sample size.

SAMPLE SIZE:Sample size is calculated at 80% study power and alpha error of 0.05
assuming standard deviation of 9.58 minutes in the duration of sensory blockade in 0.5 %
hyperbaric bupivicaine group as found in seed article.For minimum detectable mean
difference of 5 min in duration of sensory blockade in two groups, 57 patients in each group
are required as sample size which is further enhancedand rounded off to 60 patients in each
group as final size for present study expecting 5% attrition.
STUDY UNIVERSE: Cases undergoing elective caesarean section satisfying the inclusion
criteria.

RANDOMIZATION:Simple random technique by sealed envelope method would be used to

allocate cases in two groups. A total of 60 envelopes will be made, each envelope mentioning
a particular study group. One of my colleagues will pick an envelope. Patients will be allocated
to the group mentioned on the envelope.

BLINDING: The anaesthesiologist who randomizes and allocates patients into two groups
using a sealed envelope will be different from the anaesthesiologist who records the vitals and
collect blood samples. (Single blinding)

STUDY GROUPS: The study will be conducted in the following two groups of patients. Each
group consists of 30 patients.

GROUP A–Patients will be receiving 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with
preservative free 25mg (0.5ml ) of preservative free ketamine. Total volume made 2.3 ml.

GROUP B-Patients will be receiving 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with inj.
magnesium sulphate (75 mg) 0.15ml plus 0.35ml of 0.9% normal saline. Total volume made
2.3 ml.

ELIGIBILITY CRITERIA

INCLUSION CRITERIA:

• Surgery-elective caesarean section under spinal anaesthesia.

• Patients who gave informed written consent in vernacular language.
• Belonging to ASA Classes II status.
• 18–35 years of age.
• Height of the parturient 145–170 cm.

EXCLUSION CRITERIA:

• Patients with systemic diseases.

• Patients with body mass index > 38kg/cm2.
• Patients having history of preeclampsia and eclampsia,fetal distress.
• Patients having allergy to study drug.
 • Patients having contraindications to spinal anaesthesia.
• Patients consuming tranquilizers, hypnotics, sedatives.

PRE ANAESTHETIC CHECK UP

Pre anaesthetic check-up will be done before the surgery which will include
• Complete medical and surgical history of the patient including any known drug allergy
• General, systemic and airway examination
• Vital parameters like blood pressure ( BP), pulse rate (PR), oxygen saturation(SPO2),
respiratory rate (RR).

INVESTIGATIONS

• Hb%,TLC,DLC,BT,CT
• Fasting /random blood sugar
• Blood urea,serum creatinine when indicated
• Serum bilirubin, SGOT, SGPT,PT/INR when indicated
• Serum electrolytes when indicated
• Electrocardiogram (ECG) when indicated

Informed written consent will be obtained in vernacular language after completely

explaining the study protocol and procedure.

PROCEDURE
After obtaining institutional ethical committee approval and informed written consent from
each patient, a hospital-based interventional prospective randomised study will be conducted.
This study will include 60 patients of ASA grade II aged between 18 and 35 years requiring an
elective caesarean section. Parturient was kept nil by mouth for 8 h before surgery and
premedicated with tab. Ranitidine 150 mg day before surgery. An 18-gauge intravenous (IV)
line will be inserted in all the participants. Patients will be received in operation theatre and
will be identified. Before the induction of spinal anaesthesia, Ringer’s solution at 10ml/kg will
be infused, and baseline standard monitoring like noninvasive blood pressure (BP), Pulse rate,
electrocardiograph and pulse oximetry will be recorded.
The spinal anaesthesia will be administered by a 25-gauge Quincke spinal needle at L3-L4
interspace, parallel to the dural fibre, while the subject will be in a sitting position. Spinal
anaesthesia with 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with preservative free 25mg
(0.5ml ) of preservative free ketamine in group A and 0.5% hyperbaric bupivacaine 1.8 ml (9
mg) with inj. Magnesium sulphate (75 mg) 0.15ml plus 0.35ml of 0.9% normal saline in group
B will be given. Patients will be placed in 15° left lateral position and Oxygen at 5 L.min−1 with
a face mask administered to all the parturient during the surgery.
Blood pressure, pluse rate, ECG, and pulse oximetry will be recorded every 5-minute intervals
during the first 15 minutes of surgery and then every 15 minutes until the end of the surgery.
Sensory block level will be assessed (based on loss of sensation to pinprick) immediately after
the subject is made supine and every 1 minute thereafter until block reached T6 sensory level.
The measured time will be recorded as the onset of complete sensory block, and at this time,
surgery will be allowed.
A modified Bromage scale will be recorded 5 minutes after the administration of spinal
anaesthesia (3-no movement; 2- only able to flex the ankle and foot; 1- able to bend the knee;
and 0- no paralysis and able to raise the extended leg). Hypotension (SBP<90mmHgor > 20%
decline from the baseline) will be treated with 6 mg of IV mephentermine; this dose will be
repeated as necessary to achieve an SBP of >90 mmHg. Additionally, if the mother’s HR <
50/min, 0.5 mg of IV atropine bolus will be administered.Total dose of IV mephentermine and
duration of surgery (from skin incision to the final skin suture) will also be recorded.
 OUTCOME VARIABLES

1. Time of onset of sensory loss,

2. Time of onset of motor loss,
3. Time taken for sensory regression,
4. Time taken for motor regression,
5. Duration of analgesia.

OUTCOME ANALYSIS

• Data would be entered on MS Excel. Continuous data would be summarised in

measures of mean and standard difference between 2 means would be analysed using
Student’s t- test. Intergroup variation in mean sensory and motor onset would be
analysed using ANOVA.

• Count data would be expressed in form of proportions and difference in proportions

would be analysed using Chi-square test. The level of significance would be kept 95%
for all statistical analysis.
 FLOWCHART

STUDY UNIVERSE (PATIENTS UNDERGOING

ELECTIVE INFRAUMBILICAL SURGERIES UNDER
SPINAL ANAESTHESIA)

PAC + SCREENING

ELIGIBILITY EXCLUDE FROM

CRITERION STUDY
NO

YES

INFORMED AND WRITTEN CONSENT

STUDY POPULATION (N=120)

RANDOMIZATION AND ALLOCATION INTO 2

GROUPS USING SEALED ENVELOPE METHOD

GROUP A GROUP B
(N=60) (N=60)

OUTCOME VARIABLES OUTCOME VARTIABLES

STATISTICAL ANALYSIS

INFERENCE
 METHODOLOGY (FLOW DIAGRAM)

Patient satisfying inclusion criteria will be selected for the study

After identify the patient, check PAC and informed consent, shift patient to the OT.

Patients will be received in OT and 18 G IV cannula will be secured .

Monitor pre op vitals (HR, SBP, DBP, MAP, RR, SPO2), Start Ringer lactate infusion
at a rate of 10ml/kg.

Patient in sitting position, under all aseptic precautions will be given spinal
anaesthesia 0.5% isobaric bupivacaine 3.0 ml (15mg) with 25micrograms (0.5ml )
of fentanyl in group A and 0.5% hyperbaric bupivacaine 3.0 ml (15 mg) with 25
micrograms(0.5ml) of fentanyl in group B will be given(Time Noted)

Patients will be made to lie down and appropriate tilt will be given.

Onset to sensory block i.e., time interval between the end of administration of study
drug and the onset of cutaneous analgesia at T10 was evaluated using midline bilateral
pin prick every minute.

Degree of motor block will be assessed when cutaneous sensations will be lost at
T10 using modified Bromage scale

Duration of analgesia will be recorded from the time of intra thecal injection of the
drug to the time when the patient complains of pain and first dose of rescue analgesia

Post operatively patient was assessed for intensity of pain every 15 min for 1st h, every 30 min
till 3rd h, every hour till 6th h, and at 12th and 24th h
 PARTICIPATION INFORMATION SHEET

Study Title: COMPARISON OF ANALGESIC EFFECTIVENESS OF INTRATHECAL

BUPIVACAINE WITH KETAMINE VERSUS MAGNESIUM SULPHATE IN PARTURIENTS
UNDERGOING ELECTIVE CAESAREAN SECTION.
Investigator: Dr. NAVDEEP KUMAR MANSINGHKA
Supervisor: Dr. HARPREET KAUR

• Purpose: Purpose of study is to compare analgesic efficacy of ketamine vs magnesium

sulphate when added to hyperbaric bupivacain in patients undergoing caesarean section
under spinal anaesthesia.
• Information: We will discuss with you about the procedure that is use ketamine and
magnesium sulphate in spinal anaesthesia, pros and cons of the same and occurrence
complications.

• Confidentiality: The information in the study record will be kept confidential. The
data will be secured and be made available only to the persons conducting the study
and to the regulatory authority. The data will not be made available to any other
individual unless you will give permission in writing. No reference will be made in
oral or written report which could link you to study. The results of the study will be
communicated to the subject unless deemed necessary.

• Participation: Your participation in the study is voluntary. You may deny

participation at any time without penalty and without the loss of benefits to which you
are otherwise entitled. Refusing to participate will not affect you anyway.
 STUDY PROFORMA

COMPARISON OF ANALGESIC EFFECTIVENESS OF

INTRATHECAL ISOBARIC BUPIVACAINE WITH
FENTANYL VERSUS HYPERBARIC BUPIVICAINE WITH
FENTANYL IN PARTURIENTS UNDERGOING ELECTIVE
INFRAUMBILICAL SURGERIES
Candidate’s Name : Dr. MADHAVI SINGH

Guide : Dr. SHRIPHAL MEENA

Group

• Name:
DEMOGRAPHIC DETAILS
• Age:
• Weight:
• Height:
• Gestational Age:
HISTORY
• Present illness if any:
• Drug history:
• Family history:
• Past history:
• Personal history:
GENERAL PHYSICAL EXAMINATION
• Anaemia:
• Cyanosis:
• Jaundice:
• Oedema:
• Blood pressure:
• Respiratory rate:
• Pulse:
 • Temperature:
• Psychological status
• Lymphadenopathy:
AIRWAY ASSESSMENT
• Mouth opening:
• Mallampatti score:
• Neck movements:
• Local examination of neck :
SYSTEMIC EXAMINATION
• Cardiovascular system:
• Respiratory system:
• Gastrointestinal system:
• Nervous system:

INVESTIGATIONS
• HAEMOGLOBIN:
• TLC:
• DLC:
• BT/CT
• SERUM UREA
• BILIRUBIN(TOTAL):
• PT/INR:
• RBS:
• PLATELET COUNT:
• SGOT/SGPT
• SERUM NA+/K+

HAEMODYNAMIC PARAMETERS (preoperative and intraoperative)

TIME (min) SBP DBP MAP HR SPO2 RR
PRE OP
01 min
02 min
03 min
05 min
10 min
15 min
30 min
45 min
60 min
75 min
90 min

TIME TO REACH
Sensory block Min
Motor block Min

TIME TO REGRESS
Sensory block Min

Motor block Min

DURATION OF ANALGESIA
From intrathecal injection to First dose of Min
rescue analgesia

POST OPERATIVE MONITORING

TIME(min) SAB DBP MAP HR SPO2 RR PAIN

15 min
30 min
45 min
1 hr
 1.5 hr
2 hr
2.5 hr
3 hr
4 hr
5 hr
6 hr
12 hr
24 hr

SPINAL ANESTHESIA RELATED COMPLICATIONS

Nausea
Vomiting
Shivering
Respiratory depression
Failed spinal anesthesia

VAS scoring

CONSENT FORM अ :
COMPARISON OF ANALGESIC EFFECTIVENESS OF
INTRATHECALIL ISOBARIC BUPIVACAINE WITH FENTANYL VERSUS
HYPERBARIC BUIVICAINE UNDERGOING ELECTIVE INFRAUMBILICA
SURGERIES – A RANDOMISED INTERVENTIONAL STUDY, SMS
MEDICAL COLLEGE AND ATTACHED GROUP OF HOSPITAL, JAIPUR
Name of student: Dr Madhavi Singh Name of Guide: Dr. Shriphal Meena

अध्ययन टदन क…………… अध्ययन नबर…………….

सहभ गा का परा ा ना म…………………………………………………………………..

जन्मततगथ…………………

पत ………………………………………….….…………………………………
माझ अध्ययन अन्वाकय ना पवसा् त र सा सभा तथा् य समझा टदए हाा तथा माझ प्रशा् न प ना का अवसर प्रदा न
क् रकया गया | मझा
ा

बता टदया गया हा क्रक इस ऑपरा शन का पहला एव दाौरा न ‘ना मक पवसभना् न क ब र में बत
शा िा का यष का अातगत माॉना िाररग

टदय गया हा |माझ बता टदय गया हा क्रक श िाका यष का अातगत का िा पवशरा् प्रक र क प्रय ग करका
ऑपरशना वा ला अाग क

अस्थ य र स स न्न कर्कय ज य ग इसक दौर न आम स न्न करन व ल दव ई Hyperbaric Bupivacaine 0.5% plus
fentanyl and Isobaric Bupivicaine 0.5% plus fentanylद ज एग , उनक ल भ (ज स ऑपर शन कदौर न ब द ददष
में कम ) और

ना टसा न (जासा उिला आन ,टदल किचा हा ना , बा .पा . एवा टदल कर्क िा का क म हा ना ) का

बा रा मा ा मा झ समझा टदया गया ह । ।

मना समझ सलय हा कर्क इस अधा्ययन मा ा मार सहभ गगत स्व का्ििाक हा, तथा यह कर्क मा ा बबना क रण बता ए
कर्कसा भ समय

अपन गचकर्कत्स य द खभ ल य क न न अिगक र पर पर्भ व प बबन िह ज न कसलए स्वत तर् ह ा

मना समझ सलय हा कर्क गचक्रकत्सा यपर्या जक का ओर सा का म करना व ला अन्य न ततकता ससमतत तथा
पवतनय मक

अिगक ररया ा का चा ला अध्ययन तथ इससा सम्बािगत हा सकना वा ला क्रकसा अनासािाा न सा सम्ब

गिात मारा स्व स्थ्य व असभलाक

क दाखना का सलए मार अना मतत कर्क आवशा्यकता नहा ा हा ग भला हा मा ा इस पररक्षण सा हिा हा टय ज ऊ ।
तथा पप मना समझ

सलय हा कर्क तता य पक्ष का दा गया या प ररत कर्क गया क्रकसा जा नका रा मा ा मारा पहचा न क उजा गर
नहा ा कर्कया जा यागा ।

उपय टत अध्ययन में भ ग ल न कसलए मैं सहमत ह ा

हस्त क्षर स क्ष हस्त क्षर मर ज

पत : पत :

GANTT CHART
 REFERENCES

1. Ila Patel, Rachana Ghandhi, Alka Shah, Manish Bhatt, Avani Suthar.(2011) Comparative study
of bupivacaine vs bupivacaine and ketamine (intrathecally) during intraoperative and post
operative analgesia in non pih caesarian section, National Journal of Medical Research,Vol 1
Issue 2 Oct – Dec 2011 : ISSN 2249 4995
2. Šklebar I, Bujas T, Habek D. Spinal anaesthesia-induced hypotension in obstetrics: Prevention
and therapy. Acta Clin Croat. 2019;58:90–5.
3. Bion JF. Intrathecal ketamine for war surgery.A preliminary study under field conditions.
Anaesthesia. 1984;39:1023–8
4. Jabalameli M, Pakzadmoghadam SH. Adding different doses of intrathecal magnesium sulfate
for spinal anesthesia in the cesarean section: A prospective double blind randomized trial. Adv
Biomed Res. 2012;1:7.
5. Alur J, Korikantimath VV, Jyoti B, Sushma KS, Mallayyagol NV. A Comparative Study of
Analgesic Efficacy of Intrathecal Bupivacaine with Ketamine Versus Bupivacaine with
Magnesium Sulphate in Parturients Undergoing Elective Caesarian Sections. 2021 Oct-
Dec;15(4):379-384.
6. S N Shrestha, B Bhattarai , R Shah. Comparative study of hyperbaric bupivacaine plus ketamine
vs bupivacaine plus fentanyl for spinal anaesthesia during caeserean section 2013 Oct-
Dec;11(44):287-91.
7. Swain A, Nag DS, Sahu S, Samaddar DP. Adjuvants to local anesthetics: Current understanding
and future trends. World J Clin Cases. 2017;5(8):307-323. doi:10.12998/wjcc.v5.i8.307
8. Banihashem N, Hasannasab B, Esmaeili A, Hasannasab B. Addition of intrathecal magnesium
sulfate to bupivacaine for spinal anesthesia in cesarean section. Anesth Pain Med. 2015;5:e22798
9. Kathirvel S, Sadhasivam S, Saxena A, Kannan TR, Ganjoo P. Effects of intrathecal ketamine
added to bupivacaine for spinal anaesthesia. Anaesthesia. 2000;55:899–904

SEED ARTICLE