RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION.
1
Name of the Candidate
And address
(In block letters)
:
DR. MANURAJ.V.S
DEPARTMENT OFANAESTHESIOLOGY.
NAVODAYA MEDICAL COLLEGE AND
RESEARCH CENTRE,
RAICHUR - 584103.
2
Name of the Institution
:
NAVODAYA EDUCATION TRUST’S,
NAVODAYA MEDICAL COLLEGE AND
RESEARCH CENTRE,
RAICHUR-584103.
3
Course of study and subject
:
M.D ANAESTHESIOLOGY. (3 Years)
4
Date of admission to the course
:
MAY 31-2012
5
Title of the Topic
“A COMPARITIVE STUDY OF BUPRENORPHINE WITH BUPIVACAINE AND
CLONIDINE WITH BUPIVACAINE IN SPINAL ANESTHESIA IN PATIENT FOR TOTAL
ABDOMINAL HYSTERECTOMY”
6
BRIEF RESUME OF THE INTENDED WORK
6.1
Need of the study :
Spinal anesthesia was introduced into clinical practice by Karl August Bier in
1898.More than a century has passed and even today, it is one of the most popular
techniques for both elective and emergency surgical procedures particularly caesarean
section, lower abdominal surgeries, orthopedic and urological surgeries just to name a
few.
The advantages of spinal anesthesia like, an awake patient, simple technique, rapid
onset of action, minimal drug cost, relatively less side effect and rapid patient turnover
has made this the choice of many a surgical procedure.
These advantages are sometimes offset by relatively short duration of action and
uncomfortable post operative period when its action wear off.
Other methods like epidural anesthesia require technical expertise, larger amount of drug
usage and sometimes even ending up with failed epidural analgesia. Therefore it becomes
necessary to enhance sensory blockade into post operative period by combining the lowest
dose of the drugs with longer duration of action and least side effect. In order to extend
intraoperative analgesia into postoperative period a number of spinal adjuvant like
opioids, clonidine, ketamine, morphine and buprenorphine and so on have been added to
prolong intrathecal bupivacaine action. However each drug has its own limitations, and a
need for alternative methods or drugs always exist.
Central neuraxial opioids, intrathecal as well as epidural, offer the benefit of
analgesia but however the related side effect include sense of dizziness, nausea, vomiting,
puritus, urinary retention and even cases of respiratory depression have been reported.
Recently buprenorphine and clonidine which is an α2 adrenergic agonist has been tried as
an adjuvant to prolong the action of local anesthetics. Intrathecal buprenorphine and
clonidine produce dose dependent analgesia and has been successfully used as a sole
analgesic via the intrathecal route.
Hence, this study was designed to evaluate the effectiveness to adding 150µgm
buprenorphine and 50µgm clonidine to bupivacaine for spinal anesthesia.
6.2
Review of Literature:
Goodison.R.R1 et al showed that hyperbaric bupivacaine produces predictable and
adjustable level of blockade which contrasts to isobaric mixture. Hyperbaric bupivacaine
has rapid onset and longer duration of action.
Stoelting2 RK et al showed that addition of clonidine 75-150µgm to bupivacaine in spinal
anesthesia prolongs the duration of sensory and motor blockade produced by local
anesthetic.
Niemi3 et al compared the effect of plain 0.5% bupivacaine with mixture of 3µg/kg
clonidine and 0.5% bupivacaine. The study concluded that duration of sensory analgesia
and motor blockade was longer in the clonidine group than in the plain bupivacaine
group.
D.Negri4 et al: looked at the interactions and effects on the cardiovascular system of
spinal anesthesia with clonidine and bupivacaine in young humans and found the addition
of 105µg clonidine to hyperbaric bupivacaine 1% was particularly useful in unilateral
spinal anesthesia, exerting minimal influence on hemodynamic parameters and a
satisfactory postoperative analgesia.
Dan Benhamou5 et al: concluded that adding a small dose of intrathecal clonidine to
bupivacaine increases the quality of intra operative analgesia and decreases pain during
cesarean section. Combining clonidine with fentanyl further improved analgesia and
demonstrated improved intraoperative spinal analgesia by adding 75µg of clonidine to
bupivacaine.
Kaabachi6 O et al conducted a study in 83% adolescents scheduled for orthopedic surgery
under spinal anesthesia using plane 0.5%
isobaric bupivacaine 0.2-0.4 mg/kg or
bupivacaine or bupivacaine with clonidine 1µg/kg. The conclusion was clonidine 1µg/kg
prolonged the duration of sensory block achieved with bupivacaine by 30 minutes and
postoperative analgesia by 120 minutes without severe adverse effects.
Borner7 U et al: In the year 1980 studied the tissue compatibility of buprenorphine with
tissues and CSF and concluded that buprenorphine can be safely administered
intrathecally.
Capogana8 G et al: in 1988 did a study in 90 patients aged 56-85 years undergoing
suprapubic prostatectomy under spinal anesthesia using bupivacaine and different doses
of buprenorphine in 30 and concluded that buprenorphine is an effective analgesic
suitable for management of postoperative pain in elderly patients.
Thomas9 W et al: in the year 1997 studied the comparative efficacy of intrathecal
buprenorphine with 1µg/kg buprenorphine and intrathecal plain bupivacaine and
concluded that buprenorphine provided prolonged postoperative analgesia without any
significant increasing side effects postoperative pain relief.
6.3
Objectives of the study:
The main objective of the study is to compare buprenorphine and clonidine
intrathecally with bupivacaine and to assess the onset and duration of sensory and
motor blockade and postoperative analgesia.
7
MATERIALS AND METHODS:
7.1
Source of Data:
The clinical study will be conducted on 60 adult patients of ASA physical status I &
II in the age group of 18 years to 55 years, posted for elective Total abdominal
hysterectomy under spinal anesthesia after taking informed consent at Navodaya Medical
College Hospital, Raichur.
7.2
Place of Study:
Department of Anaesthesia, Navodaya medical College and Research Centre, Raichur.
7.3
Methods of collection of Data :
Study Design:
Randomised Control Trial.
METHODOLOGY:
This clinical study will be conducted on 60 ASA grade Ι/ΙΙ patients aged 18-55 years
undergoing elective hysterectomy coming to Navodaya medical College from November
2012 to December 2014.
Patients will be divided into two groups of 30 patients each:
Group B( Buprenorphine group) patients will receive intrathecally 0.5% hyperbaric
bupivacaine 3.5 ml + 150µg buprenorphine (Total 4 ml) whereas Group C( Clonidine
group) patient will receive intrathecally 0.5% hyperbaric bupivacaine
3. 5 ml + 50µg
(Total 4 ml).
The following parameters will be assessed:
Vital parameters:
Heart Rate, Blood Pressure, Respiratory Rate and SpO2 monitoring at 1,3,5,10,15,20,30
minutes and half an hourly till the end of surgery.
Assessment of sensory blockade (pin prick) Onset, duration of sensory blockade and
highest level of sensory block achieved. Assessment of motor blockade (Bromage scale)
Onset, duration and degree of motor blockade, Assessment of post operative analgesia.
(Visual analog scale will be recorded 3, 6, 12 hours post operatively).
INCLUSION CRITERIA:
1. ASA Grade 1 and 2 patients
2. Age group of 18 – 55 Years
3. Patient given valid informed consent
4. Those patients scheduled to undergo elective total abdominal hysterectomy.
EXCLUSION CRITERIA:
1. Patient refusal.
2. Patients belonging to ASA grade 3 and 4.
3. Patient’s on opioids and α2 agonist like clonidine.
4. Patient with gross spinal abnormalities, localized skin sepsis, hemorrhagic
diathesis or neurological involment and diseases.
5. Head injury cases.
6. Patient with cardiac, pulmonary, hepatic or renal disorders
7. Patient with peripheral neuropathy.
Data Analysis:
The data collected will be entered on excel spreadsheet after coding. The data will be
further processed and analyzed using SPSS Statistical Software Version 17.0. The mean
and standard deviation will be computed for quantitative data. Proportions will be
calculated for qualitative data. Appropriate Test of Significance will be used and a P
Value < 0.05 will be considered significant.
7.4
Does the study require any investigation or intervention to be conducted on patients
or other humans or animals? If so, please describe briefly.
Yes, the study requires the following investigations:
1. Estimation of hemoglobin %.
2. Total blood cell count and Differential white blood count.
3. Blood grouping and cross matching.
6. HIV test and Hbs Ag Test.
7. Chest x-ray.
8. Coagulation profile.
9. ECG – for patients over 40 years of age
7.5
Has ethical clearance been obtained from your institution in case of 7.3?
The protocol of the study was reviewed and approved by the institutional Ethical
Committee of Navodaya Medical College and Research center, Raichur.
8
LIST OF REFERENCES :
1. Goodison, R.R and Josyala, A – Agent for spinal anesthesia – hyperbaric
bupivacaine.anesthesia; 1979; 34:375.
2. Stoelting
RK,
Antihypertensive chapter 15.
In
Pharmacology & Physiology in
Anesthetic practice, 3rd Ed. P. 305Bonnet F:1989
3. Nemi L.
Effect of intrathecal clonidine on duration of bupivacaine spinal anesthesia,
hemodynamic, and postoperative analgesia in patients undergoing knee arthroscopy.
Acta Anesthesiological Scandinavica 1994, 38: 724-728.
4. De Negri P.Sinal anesthesia with clonidine and bupivacaine in young humans: interactions
and effects on the cardiovascular system. Minerva anesthesiological 1997; 63:119-25.
5. BenhamouD
Intrathecal clonidine and
fentanyl with hyperbaric bupivacaine improves
analgesia during cesarean section. Anaesth Analg1998; 87:609-13.
6. Kaabachi O, et al. Clonidine 1µg/kg is a safe and effective adjuvant to plain bupivacaine in
spinal anesthesia in adolescents Anesth analg2007; 105:516-19.
7. Borner U, Miller H, Stoyanov M and Hembelmann G: Epidural opiate analagesia (EOA)
Compatibility of opiates with tissue and CSF. Anaesthetist 1980; 29: 570-571.
8. Capogna G, Celleno D, Tagariello V, et al: Intrathecal buprenorphine for postoperative
analgesia in the elderly patient. Anesthesia 43: 128-130, 1998.
9. Thomas W, Abraham V and Kumar B: Intrathecal buprenorphine for postoperative
analgesia. Ind J Anesth 1997; 41:188.
10. Collins Pinnok, Ted Lin, Tim Smith, Fundamentals of Anesthesia 2ndedition, Greenwich
Medical Media Ltd. 2003:129-130.
11. Hogan Q, Toth J. Anatomy of soft tissues of the spinal canal.Reg Anesth Pain Med 1999;
24: 303-10.
12. Robert K Stoelting, Pharmacology and Physiology in Anesthetic Practice, 3 rd edition,
Lippincot Raven, 1999; 158-179 Ketamine-optional.
9.
Signature of the Candidate
This comparative study between clonidine &
10.
Remarks of the Guide
bupurenorphine
with
bupivacaine
for
spinal
analgesia will be useful and we are expecting to
enhance the postoperative analgesia. Therefore the
study is recommended and forwarded.
DR. B.RAMADAS MD.
11.
11.1
Name and Designation of
Guide (In block letters)
ASSOCIATE PROFESSOR.
DEPT OF ANAESTHESIOLOGY AND
CRITICAL CARE
NAVODAYA MEDICAL COLLEGE AND
RESEARCH CENTER, RAICHUR.
11.2
Signature
11.3
Co-guide (if any)
11.4
Signature
11.5
Head of the Department
DR. D.S.RAMCHANDRA. M.D.
PROFESSOR & HEAD
DEPT OF ANAESTHESIOLOGY NAVODAYA
MEDICAL COLLEGE & RESEARCH
CENTER, RAICHUR - 584103.
12
11.6
Signature
12.1
Remarks of Chairman
and Principal
12.2
Signature