SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

“A comparative study of 0.2% ROPIVACAINE AND 0.5% LIdOCAINE FOR intravenous regional anaesthesia IN surgeries OF upper limb”

Name of the candidate: DR. A.V.ABHINAV

Guide: DR. KISHAN SHETTY

Course and Subject: MD (ANESTHESIOLOGY)

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Department of Anesthesiology,

Father Muller Medical College Hospital

Kankanady, Mangalore – 575002. August - 2012

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. A.V.ABHINAV
post Graduate Resident
Dept of ANESTHESIOLOGY
Father muller medical college
Kankanady
Mangalore – 575002
2. / NAME OF THE INSTITUTION / Father muller medical college
Kankanady
Mangalore – 575002
3. / COURSE OF STUDY AND SUBJECT / MD (ANESTHESIOLOGY)
4. / DATE OF ADMISSION TO COURSE / 09-04-2012

5. TITLE OF THE TOPIC

“A comparative study of 0.2% ROPIVACAINE AND

0.5% LIDOCAINE FOR INTRAVENOUS

REGIONAL ANAESTHESIA IN surgeries OF upper limb”




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6.BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Intra Venous Regional Anaesthesia (IVRA) is technically simple and reliable, with success rates between 94% & 98%.
Holmes first used lidocaine as a local anaesthetic for intravenous regional anaesthesia and this technique gained success and popularity .
However, the local anesthetic most often used is lidocaine 0.5%, which has a relatively brief duration of action, which may affect the duration of intraoperative analgesia, tourniquet tolerance, and redistribution of drug after tourniquet release⁽⁴⁾. It would be beneficial to use a longer acting drug such as bupivacaine, but it is avoided in view of its ability to cause irreversible cardiac arrest if the drug enters the systemic circulation⁽⁶⁾.
Ropivacaine, a newer amide local anesthetic, is structurally related to bupivacaine with almost as long a duration of action, however, ropivacaine is not known to cause depression of cardiac conduction, presumably because it is a pure s-enantiomer⁽⁴⁾. Clinical use of ropivacaine is well established for epidural anesthesia and peripheral nerve blocks, but much study hasn’t been done for its uses and effects in IVRA.
The potential use of a local anesthetic that could provide anesthesia of greater duration than lidocaine with less toxicity than bupivacaine prompted the present comparison of ropivacaine and lidocaine for IVRA in healthy volunteers and thus arose the need for the study. A 0.2% solution is to be used because it is the commercially available concentration of ropivacaine for IVRA.
REVIEW OF LITERATURE:
Knudsen et.al.,1997⁽⁶⁾, studied the CNS & CVS effects of IV infusions of ropivacaine, bupivacaine and placebo in volunteers and concluded that bupivacaine reduced both systolic and diastolic function compared with placebo, while ropivacaine reduced only systolic function.
Hartmannsgruber et.al., 1999⁽⁴⁾, studied the comparison of ropivacaine 0.2% and lidocaine 0.5% for IVRA in volunteers and concluded that though Lidocaine and ropivacaine provided similar surgical conditions, after the release of the tourniquet,There was no prolonged sensory blockade or no significant CNS and CVS side effects were observed with ropivacaine.
McClean et.al.,2000⁽³⁾, studied the use of ropivacaine in regional anaesthesia and concluded that ropivacaine is a well tolerated regional anaesthetic with an efficacy similar to bupivacaine., but it is a preferred option because of its reduced CNS and CVS potential and its lower propensity for motor block.
Atanasoff et.al, 2001⁽¹⁾, studied the comparative study of ropivacaine 0.25 and lidocaine 0.5% for ivra in outpatient surgery and concluded that Ropivacaine 0.2% may be an alternative to 0.5% lidocaine for IVRA in the outpatient surgical setting. They concluded that the longer lasting analgesia in the immediate postoperative period may be due to a stronger and prolonged tissue binding effect of ropivacaine.

Peng et.al.,2002⁽⁵⁾, studied the comparison of anaesthetic effect between 0.375% ropivacaine versus 0.5% lidocaine for IVRA in forearm surgeries and concluded that 0.375% Ropivacaine provides effective anaesthesia and superior post operative analgesia compared with 0.5% lidocaine.
AsikI et.al ., 2009⁽²⁾, studied the comparison of ropivacaine 0.2% and 0.25% with lidocaine 0.5% and concluded that the longer tolerance times for the distal tourniquet, prolonged analgesia after tourniquet release, and lower analgesic requirements post operatively make ropivacaine 0.2% and even 0.25% an alternative to lidocaine for IVRA.
OBJECTIVES OF THE STUDY:
To study and compare the : -
1.Onset of action between 0.2% Ropivacaine and 0.5% Lidocaine
2.Duration of Sensory & Motor block between 0.2% Ropivacaine and 0.5% Lidocaine
3.Quality of Anaesthesia with regard to pain scale Grading from 1 to 5.
4.Post operative analgesic effect with 0.2% Ropivacaine and 0.5% Lidocaine

7. / MATERIAL AND METHODS
7.1  SOURCE OF DATA :
Patients posted for surgeries of upper limb less than 1 hour duration at Father Muller Medical College and Hospital from August 2012 to July 2014.
7.2 METHOD OF COLLECTION OF DATA:
Study type: Prospective Randomised, Double blind
Duration of study: Two years
Sample size: 60 patients selected using purposive sampling technique
INCLUSION CRITERIA:
Patients for upper limb surgeries of less than 1 hr duration:-
1. between the ages of 18-65 years, of either sex,
2. with normal baseline ECG rhythm,
3. of ASA grade I or II.
EXCLUSION CRITERIA:
Patients with:-
1. Documented allergies to any drugs, especially Local Anaesthetics
2. Patients with H/o CNS/CVS abnormalities/Pregnant women
PLAN OF STUDY:
A detailed history will be taken and complete clinical examination is to be done to exclude patients with history of CNS/CVS Abnormalities. Routine investigations like blood grouping, haemoglobin, blood urea and blood sugar will be done. ECG will be taken to rule out the presence of any cardiac disease. Pre-operative Vitals, respiratory rate, blood pressure and conditions of heart and lungs are to be noted. Patients’ weight should be recorded.
Written and informed consent will be taken prior to scheduled operation.Patients will be explained about the procedure of intravenous regional anaesthesia.
Patients are randomly divided into two groups:
Group A- 0.5% lidocaine - 40ml
Group B- 0.2% Ropivacaine – 40ml
MONITORS:
1. NIBP monitor or sphygmomanometer
2. ECG
3. SpO2
4. Pulse Rate
TECHNIQUE: An 18G IV cannula is to be inserted into a vein on one of the non operating limb for the purpose of administering fluids or drugs.
CANNULATION FOR IVRA: 20 G intravenous cannula should be introduced into suitable vein on dorsum of hand that is to be operated as distally as possible and firmly secured
TOURNIQUET: Cotton padding is to be placed on proximal part of the limb to be operated. Double tourniquets set up connected to pneumatic pressure guage should be placed over it.
EXANGUINATING THE EXTREMITY: The arm to be operated shall be elevated to 90˚ from the body above the level of heart for 5minutes to drain the blood from the limb. A bandage is to be wrapped tightly around the arm from most distal part to near the pneumatic tourniquet for further exangunate.The proximal cuff will be inflated to 100mm Hg higher than the systolic BP and the bandage is to be removed
Injecting the anaesthetic solution: The limb should be placed horizontally and local anaesthetic to be injected steadily.
Group A patients receiving 40 ml solution containing 0.5% Lidocaine
GROUP B patients receiving 40ml solution containing 0.2% Ropivacaine
After injecting, IV cannula is removed, pressure should be applied to venepuncture site for some time till bleeding stops. The patient is then to be monitored and following parameters are to be noted
1. Tourniquet time
2. Onset of Action of the anaesthetic assessed by pin prick sensation
3. Duration of of analgesia as per time to requirement of first analgesia
4. Assesment of block: Six areas supplied by radial ,median and ulnar nerves are to be tested in sequence. At 90 second intervals after administration ,the sensory block will be assessed by using a 24G needle. The patient will verbally signify the sensation as pin prick,touch or absent. Cold sensation will be assessed using a cube of ice placed in sterile test tubes. Motor function will be assessed at 90 second interval by asking the subject to flex and extend his wrist and fingers. Complete motor block shall be considered when no voluntary movement was possible.
5.Pulse rate ,blood pressure- to be monitored every 3minute for first 15 minutes, thereafter every 5minutes.
6. Tourniquet release time and monitoring after tourniquet release.
7. Complications arising intra and post operatively if any
GRADING OF ANALGESIA :Method adopted was given by R.J.WARE(1979)
GRADE / DESCRIPTION
1.EXCELLENT
2.GOOD
3.FAIR
4.PARTIAL
5.POOR / Complete analgesia and motor loss as evidenced by inability to move fingers.
Complete analgesia but no motor paralysis
Loss of pain sensation but discomfort to deep pressure still present
Only partial and patchy analgesia,requiring supplementation.
No analgesia at all,requiring general anaesthesia
STATISTICAL ANALYSIS: Collected data will be analysed by ANOVA (analysis of variance) for repeated measures and Chi-square test.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR ANIMALS?
NO
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
YES
8. LIST OF REFERENCES:

(1). Atanassoff PG,Ocampo CA,Bande MC,Hartmannsgruber MW,Halaszynski TM.,Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut: Ropivacaine 0.2% and lidocaine 0.5% for intravenous regional anesthesia in outpatient surgery., Anaesthesiology. 2001,Sep:95(3):627-31

(2). Asik I, Kocum AI, Goktug A, Turhan KS, Alkis N.,Department of Anesthesiology and Reanimation, Ankara University Medical School, Ankara, Turkey: Comparion of ropivacaine 0.2% and 0.25% with lidocaine 0.5% for IVRA.J.Clin Anesth.2009,Sep;21(6):401-7
(3). McClellan KJ, Faulds.D.Adis International Limited, Auckland, New Zealand : Ropivacaine: an update of its use in regional Anaesthesia.Drugs.2000,Nov;60(5):1065-93
(4). Hartmannsgruber MW,Silverman DG,Halaszynski TM,Bobart V,Brull SJ,Wilkerson C,Loepke AW,Atanassoff PG.,Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06250-8051, USA : Comparion of ropivacaine 0.2% with lidocaine 0.5% for IVRA in volunteers. Anesth Analg.1999,Sep;89(3):727-31
(5). Peng PW,Coleman MM,McCartney CJ,Krone S,Chan VW,Kaszas Z,Vucemilo I.,Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada : Comparison of anaesthetic effect bet 0.375% ropivacaine versus 0.5% lidocaine in forearm I.V.R.A. Reg Anesth Pain Med.2002,Nov-Dec;27(6):595-9

(6).Knudsen.K,Beckman Suurküla M,Blomberg S,Sjövall J,Edvardsson N.,Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Göteborg : Central nervous and cardiovascular effects of I.V. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth. 1997 May;78(5):507-14


PROFORMA SL.NO:
NAME: SEX: DATE:
AGE: WT: OP.NO.:
PRE ANESTHETIC CHECK UP:
HISTORY: GENERAL PHYSICAL EXAMINATION:
RR: PR:
TEMPERATURE: BP:
SYSTEMIC EXAMINATION: MALLAMPATTI:
RS:
CVS:
PA:
CNS:
ASA:
DIAGNOSIS:
INTRAOPERATIVE:
Time / 5 minutes / 10 minutes / 15 minutes / 20 minutes / 25 minutes
HR
SBP
DBP
MAP
RR
HR- Heart Rate, SBP-Systolic Blood Pressure, DBP-Diastolic Blood Pressure, MAP- Mean Arterial Pressure, RR-Respiratory Rate
TIME OF INJECTION :
TIME OF ONSET:
SENSORY ANESTHESIA: PRESENT ABSENT
MOTOR BLOCKAGE:
RHYTHM CHANGES IN ECG: PRESENT ABSENT
DURATION OF ANAESTHESIA :
SIDE EFFECTS IF ANY:
GRADE OF ANALGESIA:
AFTER REMOVAL OF TOURNIQUET AND POST OPERATIVE:
Time / 5 minutes / 10 minutes / 15 minutes / 20 minutes / 25 minutes
HR
SBP
DBP
MAP
RR
TIME TO RECOVERY:
TIME OF REQUIREMENT FOR FIRST ANALGESIA:
SIGNATURE OF CANDIDATE SIGNATURE OF STAFF