Rajiv Gandhi University of Health Sciences, Karnataka , Bangalore s15

SYNOPSIS

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA , BANGALORE

“TO STUDY THE EFFECT OF PRETREATMENT WITH LIDOCAINE AND DICLOFENAC IN REDUCING SUCCINYLCHOLINE INDUCED MYALGIA”

NAME OF THE CANDIDATE : DR. RITHESH JOSEPH D’CUNHA

GUIDE : DR. B. RADHESH HEGDE

COURSE AND SUBJECT : M.D. (ANAESTHESIOLOGY)

DEPARTMENT OF ANAESTHESIOLOGY, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE - 575002. 2010 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA , BANGALORE.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE AND DR. RITHESH JOSEPH D’CUNHA

ADDRESS ( IN BLOCK LETTERS) POST GRADUATE STUDENT

DEPARTMENT OF ANAESTHESIOLOGY

FATHER MULLER MEDICAL COLLEGE

MANGALORE 2. NAME OF THE INSTITUTION FATHER MULLER MEDICAL COLLEGE,

KANKANADY, MANGALORE – 575002. 3. COURSE OF STUDY AND SUBJECT 2010 MD ANAESTHESIOLOGY

4. DATE OF ADMISSION TO COURSE APRIL 30th 2010 5. Title of the topic

“TO STUDY THE EFFECT OF PRETREATMENT WITH

LIDOCAINE AND DICLOFENAC IN REDUCING

SUCCINYLCHOLINE INDUCED MYALGIA”

6. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR THE STUDY

2 Succinylcholine is considered by many to be the best drug for providing ideal in- tubating conditions for short surgical procedures and rapid sequence induction. Howev- er, in addition to a number of infrequent, but well known, untoward effects, its useful- ness is limited by the frequent occurrence of postoperative myalgia. This is often listed as a minor adverse effect but it may be a very distressing experience for the patient. Presence of succinylcholine induced myalgia increases the length of stay in hospital and cost of treatment and is of greater disadvantage in day care surgery.

Therefore, the prevention of succinylcholine induced myalgia is an important strategy. Several drugs like lidocaine, rocuronium, diazepam and NSAID’s have been studied to decrease the incidence and severity of post operative myalgia. Amongst these lidocaine and diclofenac has been proved to be beneficial.1 No comparative study has been done to evaluate the effectiveness of these two drugs. So the purpose of this study is to compare the effect of pretreatment with intravenous lidocaine and intramuscular diclofenac in succinylcholine induced post operative myalgia.

6.2 REVIEW OF LITERATURE:

S K Raman, W M San in 1997 2 in their study titled “Fasciculations, myalgia and biochemical changes following succinylcholine with atracurium and lidocaine pretreatment”, studied 80 ASA 1 patients of age group 20-50 years who were posted for ENT surgery lasting for one hour with tracheal intubation being required and concluded that atracurium and lidocaine individually reduce postoperative myalgia, with further decrease occurring when used together.

Kahraman S,Ercan S,Aypaar U in 1993 3 conducted a double blind study on “Effect of preoperative i.m. administration of diclofenac on suxamethonium-induced myalgia”. They studied 34 patients who presented for elective opthalmic surgery, who received I.M. diclofenac 75mg 20 minutes before surgery and concluded that preoperative i.m.administration of diclofenac effectively reduces incidence and intensity of muscle pain.

C. McLoughlin, G.A. Nesbitt, J.P. Howe in 1987 4 conducted a study on “Suxamethonium induced myalgia and effect of pre-operative administration of oral aspirin”. They studied unpremedicated patients who presented for routine surgery, who

3 received soluble aspirin 600mg orally one hour before surgery and concluded that preoperative oral administration of aspirin effectively reduces muscle pain

In another study titled “Pretreatment before succinylcholine for outpatient

Anesthesia?”Thomas Mencke and coworkers in 20015 concluded that pretreatment with

rocuronium failed to decrease the incidence or severity of post operative myalgia.

Brain Melnick, Jagadamba Chalasani, Nonita T. Lim Uy, Preyaratt phitayakorn,

Susan V, Mellett , Thomas E. Rudy in 19876 concluded that lidocaine was effective in

decreasing myalgia caused by succinylcholine in outpatients.

In another study in 20057 by Jan-Uwe Schreiber, Christopher Lysakowski,

Thomas Fuchs-Buder, Matrin R. Tramer titled “Prevention of Succinycholine-induced

Fasciculation and Myalgia”, concluded that myalgia can be best prevented with non-

depolarizing muscle relaxants, lidocaine or non-steroidal anti-inflammatory drugs.

Objectives of the study

1. To assess the efficacy of intravenous lidocaine in reducing the incidence and

intensity of succinylcholine induced fasciculations and myalgia

2. To assess the efficacy of intramuscular diclofenac in reducing the incidence and

intensity of succinylcholine induced fasciculations and myalgia

3. To compare the efficacy of intravenous lidocaine and intramuscular diclofenac

in reducing the incidence and intensity of succinylcholine induced fasciculations

and myalgia.

7. MATERIAL AND METHOD:

7.1. Source of data

4 A sample of size 120 consenting adult inpatients of Father Muller Medical college hospital who are posted for elective minor surgery, under general anaesthesia, between the age group of 18-50 years with ASA physical status 1 and 2 will be taken up for the study using purposive sampling technique.

7.2 Method of collecting the data (including sampling procedure if any)

Inclusion criteria

Adult ASA 1 and 2 physical status of either sex between the age of

18 to 50 years of weight 40 to 65 kg posted for elective minor surgeries.

Exclusion criteria

Major surgeries, pregnancy, emergency surgical procedures.

7.3 Design of study

Prospective randomized controlled trial

Plan of study

Following approval of institutional ethical committee, 120 consenting adult patients fulfilling the inclusion criteria will be entering our study. During pre-anaesthetic check up detailed assessment of airway, respiratory and cardiovascular system will be carried out. Basic laboratory data will be reviewed.

All patients will be nil per oral for 8 hours with pre medication of Tab Ranitidine

150 mg orally 12 hours before surgery. Selected patients will be divided into three groups of 40 each, based on random number generated by computer software.

Group Pretreatment given Number of patients D Intramuscular diclofenac75mg, 20 n= 40 minutes before administering the

5 succinylcholine to right gluteal region.

L Intravenous lidocaine 1.5mg/kg 3 n=40 minutes before administering succinylcholine.

C Control n=40

In operating room, non invasive blood pressure ,pulse-oximeter, ECG monitors will be placed. Baseline SPO2, heart rate, ECG recorded, intravenous access secured.

Inj.Fentanyl 2mg/kg I.V. will be given 5 minutes before induction of anaesthesia.

Patient will be pre-oxygenated and induced with 5mg/kg. sodiumthiopentone intravenously followed by 1.5mg/kg of succinylcholine. The presence, degree and duration of fasciculation will be assessed visually on a four point scale.

0- No visible fasciculation

1- (Mild) very fine fingertip or fascial muscle movement.

2- (moderate) minimal fasciculation on the trunk and extremities

3- (severe) vigorous fasciculations on the trunk and extremities.

Tracheal intubation will be performed once the fasciculations reaches the toes. Anaesthesia will be maintained with nitrous oxide66% and oxygen. Loading dose of 0.1mg/kg vecuronium will be given followed by maintenance dose of 0.02mg/kg every 20 minutes. Neuromuscular blockade will be reversed with neostigmine 0.05mg/kg and 0.01mg/kg of glycopyrrolate intravenously at the end of the procedure. Post operative care will be standardized to all the patients. Severity and intensity of post operative myalgia will be assessed by the investigator with standardized questionnaire method. 1hour and 24 hour after surgery. Statistical Methods

Collected data will be analyzed by ANOVA for repeated measures and

6 Chi-Square test.

7.3 Does the study require any investigation or intervention to be conducted on

patients or other humans?

7.4 Has ethical clearance been obtained from your institution?

8. LIST OF REFERENCES

1. Wong S.F, Chung F “ Succinylcholine associated postoperative myalgia”.

Anaesthesia 2000, 55: 144-52.

2. Raman S.K, San W.M. “Fasciculations, myalgia and biochemical changes

7 following succinylcholine with atracurium and lidocaine pretreatment”.

Can J Anaesth 1977, 44(5): 498-502.

3. Kahraman S, Ercan S. et. al. “Effect of preoperative I.m. administration of

diclofenac on suxamethonium induced myalgia”. Br J Anaesth

1993,71:238-41.

4. McLoughlin C, Nesbitt G.A. et. al. “Suxamethonium induced myalgia and effect

of pre-operative administration of oral aspirin”. Aneasthesia 1988, 43 (7):

565-7.

5. Mencke T, Schreiber J. et.al. “Pretreatment before succinylcholine for outpatient

Anesthesia?”. Anaesth Analg 2002, 94 : 573-76.

6. Melnick B., Chalasani J. et. al. “Decreasing post succinylcholine myalgia in out

patients”. Can J Anaesth 1987, 34(3): 238-41.

7. Schreiber J, Lysakowskic. “Prevention of Succinycholine-induced Fasciculation and Myalgia”. Anaesthesiology. 2005, 103 (4): 877-83.

8 PROFORMA

SL. NO :

NAME : AGE SEX WEIGHT

PRE ANEASTHETIC CHECK UP: PR BP

AIRWAY : MODIFIED MALLAMPATTI

RS : CVS :

ASA PHYSICAL STATUS :

PREMEDICATION :

FASICULATION : 0 1 2 3

POST OPERATIVE MYALGIA : 1hr 0 1 2 3

24hr 0 1 2 3

ADVERSE EFFECT AT THE TIME OF INDUCTION - Bradycardia / Arrythmia

LOCATION OF PAIN

PAIN MEDICATION FOR POST-OPERATIVE MYALGIA a) PREMEDICATION WITH INTRAMUSCULAR DICLOFENAC b) PREMEDICATION WITH INTRA VENOUS LIDOCAINE

SIGNATURE OF THE STAFF SIGNATURE OF THE CANDIDATE

Standardised Questionnaire To Assess Post Operative Myalgia

9 1. Do you have any pains or aches or stiffness in your muscles other

than the site wherein the surgery was performed?

If the answer is no, myalgia will be graded 0=none (no pain); if the answer

is yes, the location (i.e., neck, shoulder, arm, throat, abdomen, buttocks),

the severity of pain and necessity for pain medication will be recorded.

A: If the pain is confined to one location, myalgia will be graded 1=slight

(pain confirmed to one site but causing no disability).

B: If the pain is affecting more than one location, myalgia will be graded

2=moderate or 3 = severe.

2. Does the muscle pain restrict your normal activity ? Restriction of

normal activity will be assessed as follows: can you get out of bed ?

Are you able to turn your head ? Can you cough without distress or

pain ?

A: If the answer is yes myalgia will be graded 2=moderate (pain affecting

more than one site but causing no disability).

B: If one of these questions is answered with no, myalgia will be graded

3=severe (pain affecting more than one site and causing disability).

9 Signature of the Candidate:

10 10 Remarks of the guide This study will help to reduce the incidence of succinylcholine induced post-operative myalgia.

11 Name and Designation of Dr. B RADHESH HEGDE MD 11.1 Guide PROFESSSOR DEPARTMENT OF ANAESTHESIOLOGY FR.MULLER MEDICAL COLLEGE MANGALORE-575002.

11.2 Signature

11.3 Head of Department DR. MAHABALA T. H MD PROFESSOR AND HEAD DEPARTMENT OF ANAESTHESIOLOGY FR. MULLER MEDICAL COLLEGE MANGALORE -575002.

11.2 Signature

12 12.1 Remarks Of Chairman And Principal

12.2 Signature