RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. KARTHIK LAKSHMIKANTHA
POST GRADUATE STUDENT
DEPARTMENT OF ANAESTHESIOLOGY
VYDEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE, BANGALORE –560066.
2. / NAME OF THE INSTITUTE / VYDEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE, BANGALORE –560 066.
3. / COURSE OF THE STUDY AND SUBJECT / 3 years,M.D.ANAESTHESIOLOGY.
4. / DATE OF ADMISSION TO THE COURSE / 25.05.2012
5. / TITLE OF THE TOPIC / COMPARISON OF ISOBARIC LEVOBUPIVACAINE AND ISOBARIC BUPIVACAINE IN EXTRAPERITONEAL LOWER ABDOMEN AND LOWER LIMB SURGERIES BY SUB ARACHANOID BLOCK.

Brief resume of intended work:

6.1 / NEED FOR THE STUDY : Spinal anaesthesia has several advantages such as cost effectiveness, amelioration of hyper coagulable states associated with surgeries, provides excellent muscle relaxation for lower abdomen and lower limb surgeriesand lowers the chances of post operative deep vein thrombosis and pulmonary embolism greatly 1.
Ropivacaine and Bupivacaine are the widely used amino amide anaesthetic drugs for sub arachanoid block. Accidental intra vascular or intra thecal injection of large volume of these results in systemic toxicity. Bupivacaine is more cardiotoxic and can precipitate ventricular arrythmias by its sodium channel blockade in the conduction system .ropivacaine on the other hand is a weaker drug as it has a slower onset of action and shorter duration of action limiting its use in longer duration surgeries.
In response to the above mentioned cardiotoxicity , Levobupivacaine, the pure S (−)-enantiomer of bupivacaine, emerged as a safer alternative for regional anesthesia tobupivacaine. It demonstrated less affinity and strength of depressant effects onto myocardial and central nervous vital centers in pharmacodynamic studies, and a superior pharmacokinetic profile. Clinically, levobupivacaine is well tolerated in a variety of regional anesthesia techniques both after bolus administration and continuous postoperative infusion. Reports of toxicity with levobupivacaine are scarce and occasional toxic symptoms are usually reversible with minimal treatment with no fatal outcome
Here we will be comparing the effects and side effects of 0.5% isobaric levobupivacaine and 0.5% isobaric bupivacaine.
6.2
6.3 / REVIEW OF LITERATURE :
  1. Forty nine patients undergoing transurethral prostate surgery were enrolled in this prospective, randomized and double blind study. Patients in levobupivacaine group received 5 mg levobupivacaine + 25 μg fentanyl and bupivacaine group received 5 mg bupivacaine + 25 μg fentanyl. In conclusion, for transurethral prostate surgery 5 mg levobupivacaine with 25 μg fentanyl can provide stable hemodynamic profile, patient and surgeon satisfaction and effective sensorial blockade with less motor blockade in spinal anaesthesia2.
  2. One hundred-twenty patients, ASA I-III, were randomized to receive an intrathecal injection of one of three local anesthetic solutions intrathecal administration of either 15 mg bupivacaine, 15 mg ropivacaine, or 15 mg levobupivacaine which were well-tolerated and provided similar, effective anesthesia for lower abdominal surgery. In an equal milligram dose, ropivacaine produced a shorter duration of motor and sensory block than bupivacaine or levobupivacaine, even if this was not associated with a shorter home discharge time3.
  3. 70 patients aged 18-65 years (yr.), American Society of Anesthesiologists (ASA) physical status I-II, scheduled for elective lower abdominal and lower extremity surgery under spinal anesthesia were enrolled. The patients were randomly allocated to two groups receiving either 0.5% isobaric racemic bupivacaine 3 ml. or 0.5% isobaric levobupivacaine 3 ml. for spinal anesthesia. study indicated that 3 ml. of 0.5% isobaric racemic bupivacaine and 0.5% isobaric levobupivacaine showed equally effective potencies for spinal anesthesia, regard to both the onset time and duration of motor and sensory blockade4.
  4. 60 patients aged 44-83 years, ASA I-III physical statuswere scheduled for lower limb surgery with spinal anaesthesia. 30 of them were given 3ml 0.5% isobaric levobupivacaine and the remaining 30 3 ml 0.5% isobaric bupivacaine.the two groups had similar effects in terms of sensory and motor block. 2 elderly patients who received bupivacaine had severe cardiovascular side effects like hypotension, bradycardia, nausea and weakness5.
  5. Eighty patients aged 35–85 yr with ASA physical status I–III who were scheduled for elective orthopedic hip replacement with spinal anesthesia were enrolled in the study after IRB approval. Intergroup differences between levobupivacaine and bupivacaine were insignificant both with regard to the onset time and the duration of sensory and motor blockade (11 ± 6 versus 13±8 min; 10±7 versus 9±7 min; 228±77 versus 237±88 min; 280±84 versus 284±80 min)6
OBJECTIVES OF THE STUDY:
To compare efficasy of isobaric 0.5% levobupivacaine and isobaric 0.5% bupivaine for subarachanoid block regarding intensity of sensory and motor block
To compare the hemodynamic, respiratory and neurological effects of the two drugs.
7 / MATERIALS AND METHODS :
7.1 / SOURCE OF DATA:
Patients admitted to Vydehi institute of medical sciences undergoing extraperitoneal lower Abdominal Surgeries and lower limb surgeries under SpinalAnesthesia during the period December 2012to June 2014
7.2 / METHOD OF COLLECTION OF DATA:
A randomized double blind study by using closed envelope technique will be conducted to study on the effects of spinal anaesthesia in 100 patients who will be divided into two groups of 50 each. Subarachanoid block will be performed in the first group using 3ml of isobaric 0.5% levobupavacaine and the second group with 3ml of isobaric 0.5% bupivacaine along with 25 mcg of fentanyl in each solution . A 25G quinke’s spinal needle needle will be used and various parameters
STATISTICAL METHODS APPLIED
  1. Student ‘t’test
  2. Chi square test
THE PARAMETERS MONITERED: the following parameters will be monitored at the time of administration of the drug, every 3 minutes for the first 30 minutes and every 15 minutes till the end of the surgery from the 30th minute.
Intra operatively:
  1. Bloodpressure
  2. Heart rate
  3. Respiratory rate
  4. SPO2
Sensory:
  1. Onset
  2. Level
  3. Duration
  4. Two segment regression
Motor: ( by modified bromage scale)
  1. Time
  2. Duration
Post operatively :
Nausea and Vomiting
Transient neurological symptoms
INCLUSION CRITERIA:
  1. Age : 18 – 60 years
  2. Sex : Males and females
  3. ASA grade: I – III
  4. Duration of surgery : 45 – 100 minutes
EXCLUSION CRITERIA:
  1. Hypersensitivity to the drugs used
  2. Contraindications for spinal anaesthesia
  3. Patient’s refusal for spinal anaesthesia
  4. Local sepsis at site of injection
  5. Patients with coagulation disorders

7.3 / Does the study require any investigation or intervention to be conducted on patients or other humans or animals?
Yes, preoperative investigations namely complete blood count, blood urea nitrogen, serum creatinine, HIV, HbSAg, Random blood sugar, ECG and chest X Ray will be carried out.
7.4 / Has ethical clearance been obtained from your institution in case of above investigation?
YES
8 / REFERENCES :
  1. Wylie, Churchill Davidson. A practice of anaesthesia. 7th ed. Arnold;2003 . Chapter 37, Regional anaesthesia technique.p.604.
  2. EYAkcaboy, ZN Akcaboy and Nermin Gogusb. Low dose levobupivacaine 0.5% with fentanyl in spinal anaesthesia for transurethral resection of prostate surgery. J Res Med Sci. 2011 January; 16(1): 68–73.
  3. M. Mantoulou, et.Al . Spinal anesthesia : Comparison of plain ropivacaine, bupivacaine and levobupivacaine for lower abdominal surgeries. Acta Anaesth. Belg., 2008, 59, 65-71.
  4. Thongrong C, Sathitkarnmanee T. A Comparison of Spinal Levobupivacaine and Racemic Bupivacaine for Lower Abdominal and Lower Extremity Surgery in Srinagarind Hospital. Srinagarind Med J 2007: 22.
  5. F Fattorini, at,Al . Levobupivacaine versus racemic bupivacaine inspinal anaesthesia doe orthopaedic major surgeries. Minerva Anaestesiol 2006 ; 72 : 637-44.
  6. Christian Glaser, et,Al. Levobupivacaine Versus Racemic Bupivacaine for Spinal Anesthesia. Anesth Analg 2002;94:194 –8.

9 / SIGNATURE OF THE CANDIDATE
10 / REMARKS OF THE GUIDE / Levobupivacaine has advantages of a long acting anaesthetic with less cardiotoxic effects. Hence could be safer in prolonged surgeries.
11
11.1
11.2 / NAME AND DESIGNATION OF
GUIDE.
SIGNATURE. / DR.SUDHA PRASAD
VICE PRINCIPAL
AND
PROFESSOR IN DEPARTMENT OF ANAESTHESIOLOGY.
VYDEHI INSTITUTE OF HEALTH SCIENCES AND RESEARCH CENTRE.
BANGALORE
11.5
11.6 / HEAD OF THE DEPARTMENT
SIGNATURE / DR.SADANANDGOPAL
PROFESSOR AND HEAD OF DEPARTMENT OF ANAESTHESIOLOGY.
VYDEHI INSTITUTE OF HEALTH SCIENCES AND RESEARCH CENTRE.
BANGALORE.
12
12.1 / REMARKS OF THE CHAIRMAN AND PRINCIPAL
12.2 / SIGNATURE

CONSENT FORM

Study Topic: “COMPARISON OF ISOBARIC LEVOBUPIVACAINE AND ISOBARIC BUPIVACAINE IN EXTRAPERITONEAL LOWER ABDOMEN AND LOWER LIMB SURGERIES BY SUB ARACHANOID BLOCK”

I, Mr./ Mrs./ Miss/ Dr. aged yrs would hereby declare that I have been explained in the language I understand, regarding the proposed study and give my consent to include myself as a subject in the dissertation “COMPARISON OF ISOBARIC LEVOBUPIVACAINE AND ISOBARIC BUPIVACAINE IN EXTRAPERITONEAL LOWER ABDOMEN AND LOWER LIMB SURGERIES BY SUB ARACHANOID BLOCK”. The adverse effects of undergoing spinal anaesthesia, the anaesthetic, opioids such as hypotension, bradycardia, failure of the drug and need for change in anaesthesia and its consequences have been explained in detail and also the advantages have been told in the language I best understand.

I have been informed to my satisfaction by the attending doctor, Dr. Karthik Lakshmikantha, the purpose of the work and other intervention that may be required in management of anaesthesia.

Signature of doctor Signature of patient/guardian

Name of doctor Name:

Date: Relationship: