RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the Candidate and address (in block letters) / Dr TEJAL N JIVRAJANI155/9/2, 1STFLOOR, 1ST STAGE
5TH CROSS, OKALIPURAM
(0PP JAIN TEMPLE)
BANGALORE – 560 021
2 / Name of the Institute / Kempegowda Institute of Medical Sciences, Bangalore
3 / Course of the study and subject / M.D Anaesthesiology
4 / Date of admission to course / 1/6/2012
5 / Title of the Topic / “A CLINICAL STUDY OF CLONIDINE AS AN ADJUVANT TO INTRATHECAL 0.5% BUPIVACAINE FOR TIBIAL INTRAMEDULLARY NAILING”
6 / Brief resume of intended work
6.1 Need for the study
6.2 Review of Literature
6.2Objectives of the study / Enclosed
Enclosed
Enclosed
7 / Materials and Methods
7.1Source of data
7.2Methods of collection of data
7.3 Does this study require any investigation or interventions on patients or other humans or animals? If so, describe briefly.
7.4Has ethical committee clearance been obtained of your institution / Enclosed
Enclosed
Enclosed
Enclosed
8 / List of references / Enclosed
9 / Signature of the candidate
10
11
12 / Remarks of Guide
Name & Designation of (in block letters):
11.1 Guide
11.2 Signature
11.3Head of the Department
11.4 Signature
12.1Remarks of Principal
12.2 Signature / It is documented that higher doses of clonidine is associated with major adverse effects which can be minimized by reducing its dose.Hence, this is an attempt to show that smaller doses of an adjuvant will produce analgesia with minimal acceptable side effects.
Dr MADHAVA REDDY R
PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
KIMS, BANGALORE
Dr CHAYA S
PROFESSOR and HOD
DEPARTMENT OF ANAESTHESIOLOGY
KIMS, BANGALORE
6.2 Review of literature:
Tibial intramedullary nailing surgeries can be performed under General Anaesthetia, epidural or subarachnoid block from which Subarachnoid block has been chosen by many anaesthesiologists.It is a neuraxial block where the drug is deposited into the intrathecal space. Complications of the technique and adverse effects of polypharmacy involved in General Anaesthesia can be avoided when Subarachnoid block is used.Compared to epidural anaesthetia, Subarachnoid block is easy to perform where the volume of local anaesthetics required is lesser, onset of action is faster, sensory and motor block is better12.Regarding the cost effectiveness, intrathecal block is more economical than General anaesthesia and epidural anaesthesia.
.Many local anaesthetics like lignocaine, bupivacaine and ropivacaine have been used intrathecally.It has been observed that Bupivacaine produced a longer analgesic block than Ropivacaine and also showed to have a better motor blockade1 when similar amounts of the drugs were used.
To prolong the duration of analgesia of Bupivacaine many drugs have been used as adjuvants. But these adjuvants have their own advantages and disadvantages.For example, nausea, vomiting ,pruritis and respiratory depression have been observed with intrathecal opioids 13. Intrathecal Ketamine is known to cause sedation, dizziness, nystagmus, strange feeling and postoperative nausea and vomiting 2.
Alpha 2 agonists produce analgesia by their central action7. Dexmedetomidine ,when supplemented in spinal block is characterized by intense motor block which may not suit ambulatory procedures15. Clonidine has been used by different routes oral, intravenous, intramuscular, epidural and intrathecal.. It is a better adjuvant of choice with intrathecal bupivacaine with minimal side effects.Its action is dose dependent8and has been used in various dosages to increase the quality and duration of analgesia 4,5,10.
The faster onset of action of local anaesthetics, longer duration of sensory and motor blockade 14, dose sparing action of local anaesthetics4 and stable cardiovascular parameters14 are seen with Clonidine.
Some anaesthesiologists have also observed that at lower doses of clonidine there was no prolongation of motor blockade but time for rescue analgesic was prolonged3.
6.3 Objectives of the study:
1. To assess the safety and efficacy of 0.5%Bupivacaine with Clonidine in subarachnoid block.
2. To compare the duration of analgesia with different dosages of Clonidine as an adjuvant.
MATERIALS AND METHODS
7.1 Source of data:
This study will be conducted in the Department of Anaesthesiology with cooperation from the Department of Orthopaedics at KIMS Hospital and Research Centre, Bangalore from December 2012 to September 2014.
Study design: Randimized clinical study
Sample size: 60 adults of either sex in the age group of 18-50 years posted for tibial intramedullary nailing .
Sampling method: Random sampling
Statistical analysis: Using Student’s t-test, repeated test of ANOVA and Z test.
7.2 Method of collection of data:
60 patients of ASA physical status 1 and 2 posted for surgery who fulfill the inclusion and exclusion criteria will be taken up for the study after obtaining written informed consent.
Inclusion criteria:
1. Patient aged between 18-50 years.
2. Patient with ASA physical status 1 and 2.
3. Scheduled for tibial intramedullary nailing.
Exclusion criteria:
1. Patients other than ASA physical status 1 and 2..
2. Patients having
- local infection at the site of block
- severe hypovolemia
- neurological ailments such as peripheral
neuropathy, chronic neuropathic pain ,
raised intracranial tension.
- psychiatric illnesses
- deformities of spine
- bleeding and clotting disorders
- allergy to local anaesthetics
3. Patients on antiplatelet or anticoagulant drugs
4. Patients with history of chronic headache.
5. Patient with height < 145 cm and > 170cm
6. Weight > 75 kg
7. Pregnant women
Study groups:
60 patients will be divided into two groups of 30 each
Group I - 0.5% Bupivacaine 2.5ml+0.5ml of 0.5mcg/kg Clonidine
Group II - 0.5% Bupivacaine 2.5ml+0.5ml of 1mcg/kg Clonidine.
Methodology
On admission a thorough pre operative evaluation will be done which includes a detailed history, general physical examination, systemic examination and laboratory investigations to confirm the afore mentioned inclusion and exclusion criteria. Then a written informed consent will be taken after explaining the procedure, advantages and consequences to the patient in their own language.
Procedure
Patient will be premedicated with alprazolam 0.5 mg the day before and on the day of surgery in the morning. Basal vital parameters like heart rate, blood pressure,SpO2 will be recorded. Under aseptic conditions with patient in sitting position using a 26 gauge spinal needle at L3 L4 or L4L5 interspace drug will be deposited intrathecally after free flow of CSF is seen. Patient will be put back to supine position.
Intraoperatively, onset of sensory and motor blockade, maximum level of sensory blockade attained and the time for the same will be recorded. Sedation using five point scale will be noted. HR, NIBP, ECG and SpO2 will be recorded every 2 minutes for the first 20 minutes, every 15 minutes till the end of surgery and every 30 minutes thereafter. Also duration of analgesia, sensory and motor blockade and any adverse events like nausea, vomiting, shivering , postdural puncture headache etc will be noted and treated accordingly.
Definitions
Onset of sensory blockade:
Is the time taken from deposition of study drug till the patient does not feel the pin prick at L1 level.
Time for maximum sensory blockade:
Is defined as the time taken from deposition of the study drug to the maximum sensory blockade attained.
Onset of motor blockade:
Is defined as time taken from deposition of the study drug till the patient develops modified Bromage scale Grade 1 motor blockade.
Time for maximum motor blockade:
Is defined as the time taken from deposition of the study drug to maximum motor blockade attained.
Duration of motor block:
Is defined as the time taken from onset of motor block till the patient attains complete motor recovery.
Duration of analgesia:
Is defined as the time taken from onset of sensory blockade till the patient complains of pain at the site of surgery.
Modified Bromage scale:
0 - unable to perform full straight leg raise over the bed for 5 sec
1 - unable to perform a leg raise but can flex the leg on knee
2 - unable to flex knee but can flex ankle
3 - unable to flex ankle
4 - unable to move toes
Five point scale sedation score:
1 - alert and wide awake
2 - arousable to verbal command
3 - arousable with tactile stimulation
4 - arousable with vigourous shaking
5 - unarousable
7.3 Does the study require any investigation or intervention to be carried on patients or if so, please describe briefly:
This study requires the introduction of a spinal needle into the subarachnoid space and administration of Bupivacaine and Clonidine.
The following investigations will be needed
- Routine investigations like Haemoglobin percentage, TC,DC,ESR
- bleeding time
- clotting time
- RBS
- Chest X-Ray
- ECG
- Any other investigations, if needed.
7.4 Has the ethical committee clearance been obtained from your institution?
YES
LIST OF REFERENCES
1. Gautier, DeKock,Van Streenberge, Poth, Lahaye, Goffart, Fanared, et al. Intrathecal Ropivacaine for ambulatory surgery:A comparison between intrathecal Bupivacaine and intrathecal Ropivacaine for knee arthroscopy. Anaesthesiology 1999 Nov;91(5):1239.
2. Kathirvel S, Sadhasivam S, Saxena A, Kannan TR, Ganjoo P. Effects of intrathecal Ketamine added to Bupivacaine for spinal anaesthetia. Anaesthetia 2000 Sep;55(9):899-904.
3. Dobrydnjov I, Axelsson K, Thorn SE, Mathieson P, Klockhoff H, Holmstroma B, etal. Clonidine combined with small dose Bupivacaine during spinal anaesthesia for inguinal hernioraphy: a randomized double blinded study. Anesth Anal 2003;96:1496-503.
4. Dobrydnjov I, Samarutel J. Enhancement of intrathecal lidocaine by addition of local and systemic Clonidine. Acta Anaesthesiol Scand 1999;43:556-62.
5. Dobrydnjov I, Axelsson K, Samarutel J, Holmstrom B. Postoperative pain relief following intrathecal Bupivacaine combined with intrathecal or oral Clonidine. Acta Anaesthesiol Scand 2002 Aug;46(7):806-14.
6. Niemi L. Effects of intrathecal Clonidine on duration of Bupivacaine spinal anaesthesia, haemodynamics and postoperative analgesia in patients undergoing knee arthroscopy. Acta Anaesthesiol Scand 1994 Oct;38(7):724-8.
7. Ronald D Miller, “Miller’s Anaesthesia”, Churchill Livingstone Elsevier 7th Edition,2009, 284-85.
8. Strebel S, Gurzeler JA, Schneider MC, Aeschbach A, Kindler CH. Small dose intrthecal Clonidine and isobaric Bupivacaine for orthpaedic surgery: A dose response study. Anesth Analg 2004;99:1231-8.
9. Van Tuijl I, Van Klei WA, Vander Werff DBM, Kalkman CJ. The effect of addition of intrathecal Clonidine to hyperbaric Bupivacaine on postoperative pain and morphine requirements after cessarian section: A randomized controlled trial. British journal of anaesthesia 2006;97(3):365-70.
10. Sethi BS, Samuel M, Sreevastava D. Efficacy of Analgesic effects of low dose intrathecal Clonidine as adjuvant to Bupivacaine. Indian journal of Anaesthesia 2007;51(5):415-9.
11. Filos KS, Goudas LC, Patroni O, Polyzou V. Haemodynamic and analgesic profile after intrathecal Clonidine in humans: a dose response study. Anaesthesiology 1999;91:388-96.
12. Davies, Cashman.”Lee’s Synopsis of Anaesthetia”,Butterworth Heinemann 12th Edition,1999,690.
13. Stappendel R, Weber EW, Benraad B, Van Limbeek J, Dirksen R. Itching after intrathecal morphine: Incidence and treatment. Eur J Anaesthesiol 2000;17:616-21.
14. De Negri P, Borrelli F, Salvatore R, Visconti C, DeVivo P, Mastronardi P. Spinal anaesthesia with Clonidine and Bupivacaine in young humans: interactions and effects on the cardiovascular system. Minerva Anaesthesiol 1997 Apr;63(4):119-25.
15. Anju Grewal. Dexmedetomidine:New Avennues.Journal of Anaesthesiology Clinical Pharmacology 2011;27(3):297-302.