Download 3) Elective upper limb surgeries - Rajiv Gandhi University of Health

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA.
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE
DR. JITHENDRA.C
AND ADDRESS
S/O CHINNAPPA.M.R
#147, 12TH CROSS, 6TH MAIN, N.G.E.F
LAYOUT, NAGARABHAVI,
BANGALORE-560072
ADDRESS FOR
DR. JITHENDRA.C
CORRESPONDENCE
POST-GRADUATE IN ANAESTHESIA,
DEPT OF ANAESTHESIOLOGY
M.S.RAMAIAH MEDICAL COLLEGE
BANGALORE. 560054.
2.
NAME OF THE INSTITUTION
M.S.RAMAIAH MEDICAL COLLEGE.
BANGALORE. 560054.
3.
COURSE OF THE STUDY AND
M.D ANAESTHESIOLOGY
SUBJECT
4.
DATE OF ADMISSION TO THE
30/05/2011
COURSE
EFFECT OF ADDITION OF
5.
TITLE OF THE TOPIC
DEXMEDETOMIDINE TO ROPIVACAINE
FOR SUPRACLAVICULAR BRACHIAL
PLEXUS BLOCK
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6. Brief resume of intended work.
6.1 Introduction and need for the study:
Brachial plexus block is a popular and widely employed regional nerve block of upper extremity
which avoids the unwanted effect of anesthetic drugs used during general anesthesia and the
stress of laryngoscopy and tracheal intubation. Patients can also enjoy a post operative period free
from nausea, vomiting, cerebral depression and immediate post operative pain.
Ropivacaine, a long acting amide local anesthetic causes differential sensory nerve block, with a
dose-dependent motor blockade and a safer cardiac profile1. Hand strength returned more quickly
and there was less paresthesia of the fingers in patients receiving ropivacaine than in those
receiving bupivacaine.
Adjuvants with local anaesthetics in brachial plexus block are being used to achieve quick, dense
and prolonged block. One among these being dexmedetomidine, a selective alpha 2 adrenoceptor
agonist, which has higher affinity to alpha 2 receptors compared to clonidine2. Dexmedetomidine
added to local anesthetics shortens the onset time and prolongs the duration of block and
postoperative analgesia in brachial plexus block2. Addition of dexmedetomidine in clinically
relevant doses to ropivacaine results in a dose dependent increase in the duration of sensory and
motor block3. However their combination in supraclavicular brachial plexus block has not been
tried till now, hence the need for the study.
6.2 Review of literature:
Previous studies have found that Dexmedetomidine added to Levobupivacaine for Axillary
brachial plexus block shortens the sensory and motor block onset times, prolongs the duration of
the block and also the duration of the postoperative analgesia2. In other study it was found that
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combination of Dexmedetomidine and Bupivacaine used for Greater palatine nerve Block
increased the duration of analgesia after repair of cleft palate by 50% with no clinically relevant
side effects4. Ropivacaine alone has been extensively used in various nerve block procedures and
has been proven to be advantageous over other local anesthetics. A study on rats where
ropivacaine was used in combination with dexmedetomidine for sciatic nerve block found that
there was a dose dependent increase in the duration of thermal antinociception5.
6.3 Objectives of the study:
To compare the effects of combination of Dexmedetomidine and Ropivacaine with Ropivacaine
alone for Supraclavicular brachial plexus block. The effects will be studied in terms of

Onset of sensory blockade and motor blockade

Duration of analgesia / first request for analgesic

Duration of motor blockade

Complications / side effects if any
7. Material and methods:
7.1 Source of data:
A minimum of 50 patients admitted to M.S Ramaiah Medical Teaching and Memorial hospitals
satisfying the inclusion and exclusion criteria undergoing elective upper limb surgery will be
included in the study, after obtaining the ethical committee clearance.
7.2 Method of collection of data:
As there are no studies available where ropivacaine has been used in combination with
dexmedetomidine for supraclavicular brachial plexus block a pilot study is being conducted to
arrive at the actual mean differences. 25 cases in each group will be recruited for the study and
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will be randomized to receive Ropivacaine alone or Ropivacaine with Dexmedetomidine to arrive
at the actual mean differences, and the outcome parameters being studied with the visual
analogue scale (VAS), Modified Bromage score and mean time for first analgesic. Subsequently
using this data the actual numbers to achieve the requisite precision shall be arrived over and
above the current sample size.
7.3 Type of study: A prospective study will be conducted in patients of either sex requiring
elective upper limb surgeries after obtaining an informed consent.
Inclusion criteria:
1) Age: 18 – 70 years
2) American society of anaesthesiologists (ASA) physical status I – III
3) Elective upper limb surgeries
Exclusion criteria:
1) Patient refusal for procedure
2) Any bleeding disorder or patient on anticoagulants
3) Neurological deficits involving brachial plexus
4) Patients with allergy to local anaesthetics
5) Local infection at the injection site
6) Patients on any sedatives or antipsychotics
7) Body mass index >35
Fifty patients scheduled for Elective upper limb surgery will be randomized and divided into two
equal groups. Brachial plexus will be approached by Supraclavicular route using a 22gauge 55
millimeters (mm) insulated needle (Stimuplex B`Braun) connected to a peripheral nerve
stimulator (B`Braun). Patients will be assigned randomly into one of the two groups. In group A
(n=25) 30millilitres (ml) of 0.5% Ropivacaine +1ml saline and in group B (n=25) 30ml of 0.5%
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Ropivacaine +1microgram (mcg)/kilogram (kg) Dexmedetomidine will be given. Intraoperative
sedation will be maintained with intravenous Midazolam 1 mg and intravenous Fentanyl 0.5
mcg/kg given prior to starting the procedure. Motor and Sensory block onset times; block
durations and the time of first request for analgesic will be recorded. Pain will be assessed using a
standard 100 mm Visual Analogue Scale (VAS) and Motor block by Modified Bromage Scale by
an independent anesthesiologist.
A VAS consists of a line, often 10 cm long, with verbal anchors at either end. In the
numerical scale, 0 corresponds to no pain and 10 designate the worst possible pain. Patients are
asked to choose a point on the line that represents the intensity of their current state.
Modified Bromage scale:
0- normal motor function,
1- Ability to move only fingers,
2- Complete motor block with inability to move elbow, wrist and finger
During the intraoperative period heart rate, systolic and mean arterial pressures will be noted
every 5minutes (mins) during the first 15mins, then every 15mins throughout the surgery.
Intravenous paracetamol 1gram will be given 6th hourly for the first 24 hours. Intramuscular
tramadol 50mg will be given as rescue analgesic if VAS > 3. Inadequate sensory and motor
blockade beyond 30mins following the infiltration will be considered as unsuccessful block.
Management of unsuccessful block:
In the circumstance of inadequate or patchy action of the block, the block would be supplemented
with general anesthesia.
If in case surgery was unduly prolonged and the effect of the block wore off, rescue analgesia will
be given in the form of intravenous Fentanyl 1 mcg/kg and infusion of Propofol 50-100
mcg/kg/min
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Other variables that will be recorded are:
1) Age
2) Gender
3) Coexisting diseases
4) Medications patient is receiving
5) Duration of surgery
6) Post operative infection
7) Adverse perioperative event
Statistical analysis:
The independent‘t’ test shall be employed to compare the means of the VAS score, Modified
bromage score and time of first request of analgesic
7.3 Does the study require any investigation or interventions to be conducted on
Patients or other humans or animals?
Yes. The patients will undergo the investigations recommended by the ASA guidelines for the
age prior to surgery
7.4 Has ethical clearance been obtained from your institution?
Yes.
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8. List of references:
1) Misiolek HD, Kucia HJ, Knapik P, Werszner MM, Karpe JW, Gumprecht J. Brachial plexus
block with ropivacaine and bupivacaine for the formation of arteriovenous fistula in patients with
end-stage renal failure. European Journal of Anesthesiology-2005; 22:471–484
2) Aliye E, Fusun Y, Aynur A, Cemil Y. Dexmedetomidine Added to Levobupivacaine Prolongs
Axillary Brachial Plexus Block. Anesth Analg-2010, Dec; 111(6):1548-51
3) Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol-2011, Sep, 19;
27:297-302
4) Obayah GM, Refaie A, Aboushanab O, Ibraheem N, Abdelazees M. Addition of
Dexmedetomidine to Bupivacaine for Greater Palatine nerve block prolongs postoperative
analgesia after cleft palate repair. European Journal of Anesthesiology: March 2010; 27(3):280–
284
5) Chad MB, Mary AN, John MP, Ralph L. Perineural Administration of Dexmedetomidine in
Combination with Bupivacaine Enhances Sensory and Motor Blockade in Sciatic Nerve Block
without Inducing Neurotoxicity in Rat. Anesthesiology-2009; 111(5):1111-9.
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9.
SIGNATURE OF THE CANDIDATE
SEVERAL STUDIES HAVE PROVED THE
10.
REMARKS OF THE GUIDE
ADVANTAGE OF INTRATHECAL AND
EPIDURAL
ADMINISTRATION
DEXMEDETOMIDINE,
WHILE
OF
THERE
ARE LIMITED STUDIES ON ITS USAGE IN
PLEXUS BLOCKS, HENCE THE NEED OF
OUR STUDY.
11.1
NAME AND DESIGNATION OF THE
DR. SANDHYA.K, M.D
GUIDE
ASSISTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
M.S.RAMAIAH MEDICAL COLLEGE
BANGALORE-560054
11.2
SIGNATURE
DR.GEETHA.L, M.D., P. D. F
11.3
CO-GUIDE
(NEUROANAESTHESIA)
ASSISTANT PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY
M.S. RAMAIAH MEDICAL COLLEGE.
BANGALORE-560054
11.4
SIGNATURE
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DR. RATHNA, M.D, D.A, DNB
11.5
HEAD OF THE DEPARTMENT
PROFESSOR AND HEAD OF DEPT.,
DEPARTMENT OF ANAESTHESIOLOGY
M.S.RAMAIAH MEDICAL COLLEGE.
BANGALORE. 560054.
11.6
SIGNATURE
DR. SARASWATHI RAO. M.D.
12.
DEAN AND PRINCIPAL
PRINCIPAL AND DEAN.
M.S. RAMAIAH MEDICAL COLLEGE.
BANGALORE. 560054.
12.1
REMARKS OF THE DEAN AND
PRINCIPAL
12.2
SIGNATURE
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