RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
"A COMPARATIVE STUDY OF INTRATHECAL BUPIVACAINE ALONE AND BUPIVACAINE WITH CLONIDINE IN ELECTIVE CAESAREAN SECTION"
Submitted by
Dr. SAGAR. G.C
M.B.B.S.
POST GRADUATE STUDENT IN
ANAESTHESIOLOGY (M.D.)
DEPARTMENT OF ANAESTHESIOLOGY
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATEAND ADDRESS
(in block letters) / Dr. SAGAR. G.C.
PG IN ANAESTHESIOLOGY,
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
2. / NAME OF THE INSTITUTION /
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.3. / COURSE OF STUDY AND SUBJECT /
M.D IN ANAESTHESIOLOGY
4. / DATE OF ADMISSION TO COURSE / 31st MAY 20115. / TITLE OF THE TOPIC / A COMPARATIVE STUDY OF INTRATHECAL BUPIVACAINE ALONE AND BUPIVACAINE WITH CLONIDINE IN ELECTIVE CAESAREAN SECTION
6. / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC
YES
APPENDIX-IID8. / LIST OF REFERENCES /
APPENDIX – III
9. / SIGNATURE OF THE CANDIDATE /10. /
REMARKS OF THE GUIDE
/ This study is accepted and can be carried out in Adichunchangiri hospital and research centre, B.G Nagara, Bellur.11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / Dr. CHETHANA NANDA T.N. MBBS, DA, DNB
ASSOCIATE PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
AIMS, B.G. NAGARA-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / -
11.6 SIGNATURE / -
11.5 HEAD OF DEPARTMENT / Dr. RADHA M.K, M.D
PROFESSOR AND HEAD
DEPARTMENT OF ANAESTHESIOLOGY
AIMS, B.G. NAGARA-57144811.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. M.G SHIVARAMU M.B.B.S., MD
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
APPENDIX-I
6.0 BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
Clonidine is an alpha2 adrenergic agonist that is capable of acting both independently as well as synergistically with opiods and local anaesthetics. However their primary mechanism of action is believed to be at the level of spinal cord. This includes pre and post synaptic sites of action. Presynaptically ; alpha 2 receptor activation by clonidine inhibits release of substance-p from afferent ‘c’ fibres with in dorsal horn. Post synaptically, clonidine inhibits the development of and subsequent transmission of integrated pain signals within second order neurons of substantia gelatinosa.
Spinal anaesthesia has become the preferred anaesthesia for caesarean section. Spinal anaesthesia is simple to perform, economical, produces rapid onset of anaesthesia and complete muscle relaxation. Although prolongation of the effects of local anaesthetics has been reported for oral and intravenous clonidine. The intrathecal route is more effective; clonidine prolongs the duration of action of intrathecally administered local anaesthetic (most commonly bupivacaine) and has potent antinociceptive properties7.
Intrathecal clonidine produces dose dependent analgesia; it has been used successfully as sole analgesic for pain relief in labour and for postoperative pain treatment after caesarean section3.
Intrathecal clonidine used as an adjuvant drugs to local anaesthetics. They potentiate the effect of local anaesthetics and allow a decrease in required doses. Clonidine is a partial alpha2 receptor agonist used intrathecally with a well established record of efficacy and safety. Its addition to local anaesthetics prolongs the duration of both motor and sensory spinal blockade6.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
1. Klimscha.W, Chiari.A, Krafft.P, Plattner.O, Jaslimi.R. et al.,1 in their study hemodynamic and analgesic effects of clonidine added repetitively to continous epidural and spinal blocks. (1995).
They concluded that addition of intrathecal, but not epidural clonidine, 150microgm, decreased MAP significantly compared with plain bupivacaine. The addition of clonidine does not cause cumulative hemodynamic depression after repetitive administration. The addition of clonidine to bupivacaine yields long lasting, prolonged pain relief, although hemodynamic effects require carefull monitoring.
2. Rouchette et al.,2 In their study controlled, prospective, dose ranging study of clonidine in spinal anaesthesia in 75 neonates undergoing elective inguinal herniorrhaphy. Patients were given a spinal anaesthetic with either 0.5% plain isobaric bupivacaine (1 mg/kg), or bupivacaine plus 0.25, 0.5, 1, or 2microgm/kg clonidine. Mean arterial pressure, heart rate, spo2, and duration of anaesthesia were the main data recorded. (2004)
They concluded that clonidine 1microgm/kg, added to spinal isobaric bupivacaine, doubled the duration the block without significant deleterious hemodynamic or respiratory side effects.
3. Tuijl van, klei van.W.A, Werff Vander D.B.M, Kalkman.C.J3 in their study of the effect of addition intrathecal clonidine to hyperbaric bupivacaine on postoperative pain and morphine requirements after caesarean section: a randomised controlled trial (2006)
They opined that the addition of intrathecal clonidine (75 microgm) to hyperbaric bupivacaine prolongs spinal anaesthesia after caesarean section and improves early analgesia but does not reduce the postoperative requirements of morphine consumption during first 24hrs. No clinically relevant maternal and neonatal side effects were detected.
4. Neval Boztug. M.D., Zekiya Bigat. M.D., Bilge Karsli. M.D., Nurdan Saykal., M.D., and Ertugrul Ertok. M.D4 did a comparative study of Ropivacaine and Bupivacaine for intrathecal anaesthesia during outpatient arthroscopic surgery. They concluded that “Isobaric Ropivacaine 15 mg provided a higher sensory block level and shorter sensory onset and offset times than did 7.5 mg of isobaric Bupivacaine. They concluded that 15 mg of Ropivacaine intrathecally is adequate for lower extremity surgery of shorter duration”. (2006)
5. Belhjad Amor et al.,5 in their study with combined spinal-epidural analgesia using a combination of subarachnoid bupivacaine, 2.5mg, sufentanil, 5microgm,and clonidine, 30microgm for labour pain (2007)
They concluded that although intrathecal clonidine, 30 microgm prolongs [labour] analgesia,it increases the incidence of (maternal) hypotension, and abnormal fetal heart rate patterns, and its use is thus not recommended.
This conclusion might not be quite consistent with the findings and recommendations of other researches on the very same subject.
6. Kuczkowski and Chandra6 investigated the effects (e.g. maternal satisfaction, duration and side effects of single dose spinal analgesia with combination of bupivacaine , 2.5mg morphine, 0.25mg and clonidine 45microgm, for the management of obstetric pain in labouring women. (2007)
They concluded that clonidine when added to spinal bupivacaine, prolonged the duration of block (both motor and sensory) without clinically significant deleterious hemodynamic or respiratory side effects. They also concluded that their technique was very cost effective (maternal satisfaction with this technique was very high) and it should be recommended for routine obstetric pain control in the developing world.
7. Kothari N, Bogra J, Chaudhry AK.7 On their study of evaluation of effects of intrathecal clonidine along with bupivacaine in caesarean section, where the group1 recieved 12.5mg of 0.5% hyperbaric bupivacaine and group2 received 0.5% hyperbaric bupivacaine 8mg and clonidine 50microgm. (2011)
They concluded that, the addition of intrathecal clonidine causes some sedation in postoperative periods but it provides adequate analgesia and motor paralysis at lower doses of bupivacaine. It also significantly prolongs postoperative pain relief.
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
To compare the effects of intrathecal 0.5% hyperbaric Bupivacaine 8.75 mg (1.75ml) and clonidine 37.5microgm (0.25ml), with 0.5% hyperbaric Bupivacaine 10 mg(2.0ml), in elective caesarean sections with regard to
1. The intensity of block
2. Quality of block
3. Duration of block
4. Hemodynamic response
5. Complications, if any
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
The proposed study would be conducted in Adichunchanagiri Hospital and Research Centre, B.G. Nagara, Mandya District after obtaining permission from ethical committee of the Institute.
Study will be conducted on 60 parturients in a randomized prospective manner undergoing elective caesarean section under subarachnoid block during November 2011 to July 2013. The study will be conducted over a period of 18 months.
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
In a randomised prospective study conducted on 60 parturients would be selected.
INCLUSION CRITERIA:
1. ASA physical status I and II.
2. Patients undergoing elective caesarean sections.
3. Patient giving valid informed written consent.
4. Patient Aged between 20 to 30years.
5. Patients with height more than 140cm.
EXCLUSION CRITERIA:
1. Patient’s refusal.
2. Patients with ASA grade III and more than III.
3. Patients with spinal deformities.
4. Patients with bleeding and clotting disorders.
5. Patients with neurological deficit.
6. Patients with height less than 140cm.
7. Patients posted for emergency surgery.
8. Patient with previous LSCS with scar tenderness and fetal distress.
9. Patients having any antepartum hemorrhage conditions (Abruptio placenta and placenta previa)
10. Twin pregnancies and hypertensive disorder of pregnancy.
11. Known allergy to drug.
12. Patients who fail to achieve desired sensory and motor blockade will be excluded from the study.
SELECTED PATIENTS:
A total 60 patients would be distributed in to 2 groups of 30 patients each randomly. All patients will be visited on the day prior to surgery and explained in detail regarding anesthetic procedure. A detailed pre-anaesthetic evaluation will be done including history and general examination. All patients will be kept nil per oral from 10 midnight prior to the day of surgery. Patient to be given with intravenous ranitidine 150mg and ondanseteron 4mg 2hrs prior to the anaesthetic procedure for aspiration prophylaxis. Baseline parameters are recorded. Preload with 500ml of Ringer Lactate.
PROCEDURE :
In the O.T, after securing an I.V line and placement of the monitors, under aseptic precautions lumbar spinal block will be performed.
Selected Patients will be divided into 2 groups.
Group A / 30 Patients / Will receive 1.75 ml of 0.5% hyperbaric Bupivacaine with 0.25ml of Clonidine through spinal needle.Group B / 30 Patients / Will receive 2.0 ml of 0.5% hyperbaric Bupivacaine through spinal needle.
All resuscitation equipments both for mother and baby, E.T tubes and Boyle’s machine will be kept ready. All parturients will be monitored continuously
PARAMETERS EVALUATED
1. All patients will be monitored continuously
a. Intraoperatively
i. For every 2 minutes for a period of 10 minutes.
ii. For every 3 minutes till the end of surgery.
b. Postoperatively
i. For every 1 hour for next 4 hours.
ii. Patient monitored closely for first 24 hours.
2. Heart Rate
3. Systolic, diastolic and Mean arterial pressure (NIBP)
4. Respiratory rate per minute.
5. Percentage oxygen Saturation (SPO2).
6. Continous ECG.
7. Level of sedation : assessed by Ramsay sedation score.4
a. Patient conscious and agitated.
b. Patient cooperative, oriented and tranquil.
c. Patient responds to commands only.
d. Patient has brisk response to a light glabellar tap or loud auditory stimulus.
e. Patient asleep, sluggish response to light glabellar tap or loud auditory stimulus.
f. Patient does not respond to painfull stimulus.
The score will be revaluated every 10min during the surgery and post operatively upto 120min.
8. Sensory Block: Assessed using pin-prick test on each side and patients asked about the sensation.
a. Onset time for sensory block: defined as time between injection of the drug to loss of sensation at L1 level.
b. Sensory duration: defined as time between injection and recovery of sensation of L1 level.
c. Scoring system for sensory blockade.
i. No block
ii. Sensation is present, but no pain.
iii. No sensation at the site of surgery.
9. The degree of motor block by ‘Bromage Scale’4
Scale / Criteria0 / Free movements of legs and feet, with ability to raise extended leg.
1 / Knee flexion is decreased, inability to raise extended leg, full flexion of feet and ankles present
2 / Inability to raise legs or flex knees, flexion of ankles and feet present.
3 / Inability to raise legs, flex knees or ankle or move toes.
This will be performed every 2 minutes until complete motor blockade and then every 10 minutes until return of normal motor function.
· Onset time for motor block : defined as the time between injection and complete block.
· Block duration : will be defined as the time between injection and complete recovery of motor block.
10. Mean arterial pressure, heart rate and percentage saturation of oxygen will be recorded every 2 minutes for the first 10 minutes and then every 3 minutes throughout the surgery. Patients will be considered hypotensive when their mean arterial pressure decreased to less than 20% from baseline and will be treated with injection Ephedrine 6 mg intravenously, dose titrated according to response. A decrease in heart rate to less than 60 beats per minute will be treated with injection atropine 0.02mg/kg intravenously.
a. Highest level of sensory block.
b. Onset time for highest level of sensory block.
c. Maximal level of motor block.
d. Onset time for maximal motor block.
e. Onset and offset time for motor blockade.
f. Duration of both sensory and motor block will be recorded during intraoperative period
11. Complications such as nausea, vomiting and shivering as well as treatment given will be noted down. At the end of surgery the quality of analgesia will be judged according to patients description, as follows:
Excellent - No discomfort or pain.
Good - Mild pain/discomfort, no need for additional analgesics.
Poor - Moderate to severe pain that required additional analgesics.
All patients will be observed during the postoperative period for 4 hours and later closely monitored for first 24 hours, to know the duration, quality and intensity of pain, during which the help of ward staff and ward doctors also taken.
The time for the Ist request for postoperative analgesia, recovery of motor and sensory block will be noted in both groups.
Statistical analysis of the data parameters will be done using following statistical tests
1. Standard deviation + 0.5