RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION.
|1 |Name of the Candidate |: |DR. MANURAJ.V.S |
| |And address | |DEPARTMENT OFANAESTHESIOLOGY. |
| |(In block letters) | |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: |
| | |ASA Grade 1 and 2 patients |
| | |Age group of 18 – 55 Years |
| | |Patient given valid informed consent |
| | |Those patients scheduled to undergo elective total abdominal hysterectomy. |
| | | |
| | |EXCLUSION CRITERIA: |
| | |Patient refusal. |
| | |Patients belonging to ASA grade 3 and 4. |
| | |Patient’s on opioids and α2 agonist like clonidine. |
| | |Patient with gross spinal abnormalities, localized skin sepsis, hemorrhagic diathesis or neurological involment and diseases. |
| | |Head injury cases. |
| | |Patient with cardiac, pulmonary, hepatic or renal disorders |
| | |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 : |
| |Goodison, R.R and Josyala, A – Agent for spinal anesthesia – hyperbaric bupivacaine.anesthesia; 1979; 34:375. |
| |Stoelting RK, Antihypertensive chapter 15. In Pharmacology & Physiology in Anesthetic practice, 3rd Ed. P. 305Bonnet F:1989 |
| |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. |
| |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. |
| |BenhamouD Intrathecal clonidine and fentanyl with hyperbaric bupivacaine improves analgesia during cesarean section. Anaesth Analg1998; |
| |87:609-13. |
| |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. |
| |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. |
| |Capogna G, Celleno D, Tagariello V, et al: Intrathecal buprenorphine for postoperative analgesia in the elderly patient. Anesthesia 43: |
| |128-130, 1998. |
| |Thomas W, Abraham V and Kumar B: Intrathecal buprenorphine for postoperative analgesia. Ind J Anesth 1997; 41:188. |
| |Collins Pinnok, Ted Lin, Tim Smith, Fundamentals of Anesthesia 2ndedition, Greenwich Medical Media Ltd. 2003:129-130. |
| |Hogan Q, Toth J. Anatomy of soft tissues of the spinal canal.Reg Anesth Pain Med 1999; 24: 303-10. |
| |Robert K Stoelting, Pharmacology and Physiology in Anesthetic Practice, 3rd edition, Lippincot Raven, 1999; 158-179 |
| |Ketamine-optional. |
| | |
| | |
| | |
| 9. |Signature of the Candidate | |
| 10. |Remarks of the Guide |This comparative study between clonidine & 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. |
|11. |11.1 |Name and Designation of |DR. B.RAMADAS MD. |
| | |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. |
| |11.6 |Signature | |
|12 |12.1 |Remarks of Chairman and Principal | |
| |12.2 |Signature | |
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