EFFECT OF INTRAVENOUS LIGNOCAINE AND NORMAL SALINE …

i

EFFECT OF INTRAVENOUS LIGNOCAINE AND NORMAL SALINE

PLACEBO IN PREVENTING SUXAMETHONIUM - INDUCED

FASCICULATION AND POST-OPERATIVE MYALGIA IN SURGICAL

PATIENTS

A DISSERTATION SUBMITTED TO THE NATIONAL

POSTGRADUATE MEDICAL COLLEGE OF NIGERIA IN PART

FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF

THE FELLOWSHIP OF THE FACULTY OF ANAESTHESIA

BY

ADELOSOYE ONYEKACHUKWU CHUKWUDUMEBI

M.B.B.S.(BENIN) 2003

MAY, 2016

ii

DECLARATION

I hereby declare that this work is original and was conducted in the University of Benin

Teaching Hospital, Benin City, Edo State. No part of this book has been presented to any

College for a Fellowship, neither has it been submitted elsewhere for publication.

______________________

Adelosoye,Onyekachukwu C.

iii

CERTIFICATION

The study reported in this dissertation was done by the candidate under our supervision. We

have also supervised the writing of this dissertation.

SIGNATURE: ………………………………………………………

SUPERVISOR: PROF. AMADASUN F.E.

STATUS: PROFESSOR/CONSULTANT ANAESTHETIST

YEAR OF QUALIFICATION: …………………………………………..

DATE: …………………………………………………………………..

SIGNATURE: ……………………………………………………………

SUPERVISOR: DR EKWERE I.T.

STATUS: CONSULTANT ANAESTHETIST

YEAR OF QUALIFICATION: ……………………………………………..

DATE: ………………………………………………………………………

iv

CERTIFICATION

I hereby certify that this dissertation titled “Effect of intraveous Lignocaine and Normal

Saline placebo in preventing suxamethonium - induced fasciculation and post-operative

myalgia in surgical patients” has been presented by the researcher at a Departmental

academic meeting.

PROF. AMADASUN F.E.

HEAD OF DEPARTMENT OF ANAESTHESIOLOGY

UNIVERSITY OF BENIN TEACHING HOSPITAL,

BENIN CITY,EDO STATE

DATE.................................................................

SIGNATURE......................................................

v

TABLE OF CONTENTS

Title Page…………………………………………………………………………..…… i

Declaration.....…………………………………………………………………………..ii

Certification…………...………………………………………………………………..iii

Table of Contents……………………………………………………………….............v

List of Tables…........…………………………………………………………………...vi

List of Figures…….…………………………………………………………………….vi

List of Abbreviations……...………………………………………………………….viii

Dedication………………………………………………………………………………ix

Acknowledgements…………………………………………………………….………..x

Summary...………………………………………………………………………………1

CHAPTER ONE

Introduction ………………………………………………………………………….. 3

CHAPTER TWO

Aim and Objectives……………………………………………………………………6

CHAPTER THREE

Review of Literature………………………………………………………………….7

CHAPTER FOUR

Methodology…………………………………………………………………………19

CHAPTER FIVE

Results ……………………………………………………………………………… .25

vi

CHAPTER SIX

Discussion ………………………………………………………………………… 45

Conclusion ……………………………………………………………………….. 52

Limitations of the Study ……………………………………………………. …. ..52

Recommendations ……………………………………………………………… ..52

References ………………………………………………………………………….. 53

APPENDICES

Appendix I: National Postgraduate Medical College of Nigeria

(NPMCN) Approval of Proposal……………………..........60

Appendix II: Ethical Clearance Letter…………………………….. …… 61

Appendix III: Assessment of the Presence and Extent of

Fasciculations……………………………………………… 62

Duration of Fasciculations…………………………………. 62

Appendix IV: Assessment of Post-Operative Myalgia…………. ………. 63

Appendix V: Consent Form……………………………………………… 64

Appendix VI: Data Collection Form…………………………………. …..65

vii

LIST OF TABLES

TABLE I: Socio-demographic and anthropometric measurements of Group I

and Group II…………………………………………………….. ………...27

TABLE II: Body mass index of Group I and Group II ……………...…………..…….28

TABLE III: Intensity and occurrence of fasciculations in Group I and Group II……….29

TABLE IV: Intensity of fasciculationsin the various age groups in Group I and Group

II…………………………………………………………………………….30

TABLE V: Sex distribution and occurenceof fasciculations in Group I and Group

II ……………………………………………………………………............31

TABLE VI:Sex distribution and intensity of fasciculations in Group I and II…..............32

TABLE VII: Duration of muscle fasciculations in Group I and Group II…..………….….33

TABLEVIII: Occurence of post-operative myalgia 1, 12, 24 and 48 hours after surgery

inGroup I and Group II……………..………………………………………34

TABLE IX: Sex distribution and occurence of post-operative myalgia in Group I and

Group II………………………………………………………………….....35

viii

LIST OF FIGURES

Figure 1:Baseline and Post - treatment systolic blood pressure in Group I and Group II……….36

Figure 2:Baseline and Post - treatment diastolic blood pressure in Group I and Group II………37

Figure 3: Baseline and Post – treatment Mean Arterial Pressure in Group I and Group II………38

Figure 4:Baseline and Post - treatment pulse rate in Group I and Group II……………………..39

Figure 5: Baseline and Post – treatment SpO2 in Group I and Group II………………………….40

ix

LIST OF ABBREVIATIONS

ASA…………………………………. ……………..American Society of Anesthesiologists

BL …………………………………………………….. Baseline

Bpm ……………………………………………………Beats per minute

BMI ……………………………………………………Body Mass Index

e.g ……………………………………… …………….. For example

Hr ………………………………………. …………….. Hour

IU.l-1…………………………………………………… International units per litre

Kg ………………………………..……………………. . Kilogramme

MAP ……………………………………….…………... Mean Arterial Pressure

m………………………….……………………………..Metre

µg ……………………………………………..……….. Micro-gramme

mEq.l-1 ………………………………………..………. Milliequivalent per litre

mg …………………………………………………....... Milligramme

mmHg …………………………………………...……. Millimetre of mercury

Min ……………………………………………………. Minute

ns ………………………………………………..…….. Not significant

n ……………………………………………………….. Number in each group

SpO2 ………………………………………………........ Peripheral Arterial oxygen saturation

PR …………………………………………….…… …. Pulse rate

Sec ……………………………………………………… Seconds

s ………………………………………………………… Significant

SD……………………………………………………… Standard Deviation

x

DEDICATION

This work is dedicated to God Almighty and my lovely children Adenike, Adeniyi, Adeniran and

Adeniji.

xi

ACKNOWLEDGEMENT

I wish to thank all those that have contributed to making this project a reality. First, I will

forever be grateful to God for the wisdom and strength that He gave me to undertake this project. I

thank my supervisors, Prof. F.E. Amadasun, Dr I.T.Ekwere and Prof. (Mrs.) N.P.Edomwonyi who

provided invaluable guidance during the proposal writing and through the preparation and

presentation of the dissertation. I am also grateful to Prof. C.O.Imarengiaye, for his effort in

teaching and training me.

I remain grateful to Dr T.O.Iseseleand Dr F.A.Ogadufor their constant help. I am full of

thanks to all those who made important contributions to my academic and professional

development, names too numerous to mention. The good Lord will reward you all.

I am also grateful to my family for all their unending support and encouragement.

1

SUMMARY

Background:

Suxamethonium (succinylcholine) is currently the only widely used depolarising agent. It is

the agent of choice for rapid sequence induction due to its rapid onset of action, short

duration and excellent muscle relaxation. However, fasciculation which is a side effect of

suxamethonium, is undesirable for most patients due to the body pains experienced after

surgery.

The use of 1% lignocaine (6mls) and thiopentone sodium (4mg/kg) was compared with

intravenous normal saline (placebo) (6mls) and thiopentone sodium (4mg/kg) to assess if

intravenous lignocaine will mitigate the occurrence of fasciculations and subsequently

prevent post-operative myalgia.

Methodology:

This study is a double blinded, prospective, randomised, placebo-controlled trial in adult

surgical patients. One hundred and fifty two patients were drawn from ASA I or II patients,

aged between 18 and 45 years and scheduled for elective surgery in the University of Benin

Teaching Hospital.

Following informed consent, the patients were randomized to receive thiopentone(4mg/kg)

and normal saline (6mls)(Group I) or thiopentone(4mg/kg) and 1% lignocaine (60mg) (6mls)

(Group II). They were all pre - medicated with oral diazepam 10mg at night and 6am on the

morning of surgery. The preoperative vital signs including pulse rate, blood pressure, mean

arterial pressure and oxygen saturation were recorded.

The fasciculation score, pulse rate, blood pressure, mean arterial pressure and oxygen

saturation at various time intervalswere noted and documented. The duration of muscle

2

fasciculationsat various time intervals (in seconds) was also noted and documented for all the

patients.

Results:

One hundred and fifty two ASA I and II patients, 61(40.1%) males and 91(59.9%) females

aged between 18 and 45 years participated in this study. There was no statistically significant

difference between the groups with regards to age (p = 0.194), weight (p = 0.087), and

between BMI and presence of muscle fasciculations (p = 0.148), in the respondents.

There was a statistically significant difference between the groups with regards toheight (p =

0.010) and body mass index (BMI) (p = < 0.001).

Fasciculations were absent in 17 (22.4%) respondents and present in 59 (77.6%) respondents

in Group II. All 76 (100%) patients in Group I had fasciculations in response to

suxamethonium. Fasciculations were commoner in males (96.7%) than in females (83.5%).

Postoperative myalgia occurred more in Group I (6.6%) than in Group II (3.9%) and was

found to be commoner in males.

Conclusion:

The study provides data that suggest that muscle fasciculations associated with the use of

suxamethonium for tracheal intubation is reduced with the use of 60mg of 1% intravenous

lignocaine. This is important as patients who were administered 60mg of 1% intravenous

lignocaine prior tointravenoussodium thiopentone and suxamethoniumadministration will be

spared the undesirable side effects of suxamethonium(fasciculations).

3

CHAPTER ONE

INTRODUCTION

Suxamethonium is a depolarising muscle relaxant that was introduced into medical practice

in 1951 1. It has been used for many years in situations where tracheal intubation is desired.

However its use has been associated with the occurrence of muscle fasciculations which is a

cause of concern in anaesthesia. These fasciculations have been implicated in causing many

other undesirable effects of suxamethonium which include transient hyperkalaemia, raised

intragastric, intra-ocular, and intracranial pressures and also postoperative body pains (scoline

pains, myalgia).

In a study by Famewo and Elegbe2 on post suxamethonium pains in Nigerian surgical

patients, the incidence of fasciculationswere observed to be 62% and 26 % in out-patients and

in-patients respectively. Their study also showed that the abolition of suxamethonium-

induced fasciculationswith fazadinium (a muscle relaxant) did not affect the occurrence of

post-operative myalgia. In another study by Mencke et al 3, a similar finding was seen with a

muscle relaxant (Rocuronium) which was used as a pretreatment agent. Rocuronium aborted

suxamethonium fasciculations but post–operative myalgia was not affected by the use of

rocuronium.

Muscle fasciculations and myalgia may be viewed by some as minor but this is a cause of

concern in the surgical population. Adverse effects of suxamethonium include masseter

spasm, increased risk for potentially fatal malignant hyperthermia, acute hyperkalaemia,

sinus bradycardiaand ventricular dysrhythmias 4. Other adverse effects include increases in

intra-ocular, intracranial and intragastric pressures and myalgia. The picture of these adverse

effects may vary from patient to patient.

4

Myalgia, which is a significant side effect of suxamethonium,can be a causeof considerable

distressin some patients. It may be accompanied by muscle stiffness and could last for several

days. Since there is enormousemphasis on postoperative pain control, suxamethonium-

induced myalgiais an imperative cause of concern.

Schreiber et al 5, in a meta– analysis of randomised controlled trials on the prevention of

succinylcholine induced fasciculations and myalgia, showed that pretreatment with non-

depolarizing muscle relaxants, magnesium sulphate and intravenous lignocaine were effective

in preventing fasciculations. They also showed that the best prophylactics against myalgia

were non-steroidal anti-inflammatory agents (NSAIDS), rocuronium, and lignocaine. This is

at variance with what was reported by Mencke et al 3 whose work showed that post-operative

myalgia was not aborted by rocuronium even if fasciculations were aborted. Schreiber and

colleagues 5 also noted that by using non-depolarizing muscle relaxantpretreatments, some

significant side effects, including blurred vision, diplopia, voice disorders and difficulty in

breathing and swallowing may occur. This may limit their usefulness in ambulatory surgery

where suxamethonium is in common usage.

Suxamethonium is a popular short acting muscle relaxant for ambulatory anaesthesia and

short surgical procedures 6. The use of suxamethonium may have found some popularity due

to its rapid onset of action of 30seconds and short duration. It also provides excellent

intubating conditions. This advantage may explain the wide use of suxamethonium for

ambulatory surgery in spite of its adverse effects. The choice of an effective prophylactic

against myalgia experienced by patients, who are administered suxamethonium when general

anaesthesia is done, is therefore very important for day case surgery.

5

A demonstration of the efficacy and safety of intravenous lignocaine in obtunding

suxamethonium fasciculations and myalgia in our own surgical population will be imperative.

The occurrence of fasciculations and post-operative myalgia after the intravenous

administration of suxamethonium to patients who are to have surgery and the effect of

intravenous lignocaine in obtunding these fasciculations and myalgia will be studied.

6

7

CHAPTER TWO

AIM AND OBJECTIVES

Aim: To determine the effect of pretreatment with intravenous lignocaine on the occurrence

of suxamethonium-induced fasciculations and post-operative myalgia in surgical patients.

OBJECTIVES:

(1) To determine the presence and extent of suxamethonium-induced fasciculations after

prior administration of intravenous lignocaine using a fasciculation score.

(2) To analyse the effect of age, sex and body weight (if any), on the occurrence, pattern

and duration of suxamethonium-induced fasciculations after pretreatment with

intravenous lignocaine and suxamethonium administration thereafter.

(3) To determine the haemodynamic changes after lignocaine, suxamethonium

administration and placebo (normal saline), suxamethonium administration.

(4) To determine the occurrence of post-operative myalgia after administration of

intravenous lignocaine and suxamethonium.

NULL HYPOTHESIS

The occurrence of fasciculations and post-operative myalgia in patients given a combination

of normal saline, thiopentone and suxamethonium is the same as for those given lignocaine,

thiopentone and suxamethonium. Any difference observed is due to chance.

ALTERNATE HYPOTHESIS

The occurrence of fasciculations and post-operative myalgia in patients given a combination

of normal saline, thiopentone and suxamethonium is not the same as those given lignocaine,

thiopentone and suxamethonium. Any difference observed is real and not due to chance.

8

CHAPTER THREE

LITERATURE REVIEW

Fasciculations are defined as visible, fine and fast spontaneous and intermittent contractions

of muscle fibres and has also been called verminosis because they look like worms moving

under the dermis of the skin 9, 10.

Fasciculatons can be found in individuals with no previous neurological disease. These

fasciculations have been defined as Benign Fasciculation Syndrome (BFS) which have been

reportedin some young healthcare workers11,12. Theseyoung health care workershad

complained of fasciculations in the lower limbs, which initially had normal muscle strength.

The fasciculation potential were of the simple type, motor conduction was normal and no

signs of denervation were apparent. It has been suggested that physical exercise, stress,

fatigue, and caffeine abuse can precipitate or aggravate fasciculations13.

Fermont et al 14 reported the prevalence of fasciculations in healthy adults. The study was

conducted in fifty eight individuals from different age groups and it was reported that of their

total sample, 43% had fasciculations. They also observed that older individuals had more

fasciculations than younger adults. This observation shows that older individuals may have

certain characteristics that predispose them to fasciculation and such characteristics come as

one gets older. These characteristics may not be found in younger individuals. The reason for

the findings byFermont et al was however not explained.

In clinical practice, certain conditions have been implicated in causing fasciculations. Such

conditions include movement disorders(e.g. Espinocerebellar degeneration {type 3 and 36}

and Parkinsonism),motor neuron diseases (e.g. amyotrophic lateral sclerosis and post-polio

syndrome), kidney disease, syndrome of inappropriate secretion of thyrotropin and

hypophosphatemia 10.

9

Some medications have also been implicated in the cause of fasciculations and act as risk

factors for the development of fasciculation. Example is oral corticosteroids when given

atimmuno-suppressive doses in patients with immune-mediated kidney disease15. Another

drug found to cause muscle fasciculations istopiramate which is used for the treatment of

migraine16. Other drugs also implicated as causative agents of muscle fasciculations

areisoniazid, flunarizine,neostigmine,caffeine, mercury and lithium 17, 18.

Tracheal intubation is usually carried out under a combination of general anaesthesia and

neuromuscular blockade. A short acting neuromuscular blockeris indicated in situations

where rapidly securing and maintaining a patent airway is mandatory. Such situations are

seen in surgeries for patients at risk of regurgitation and aspiration of gastric contents, head

and neck surgeries and surgeries in abnormal positions e.g. prone position. Suxamethonium

which is the drug of choice when rapid and excellent muscle relaxation for laryngoscopy and

tracheal intubation is desired is not without side effects. This depolarising neuromuscular

blocker causes fasciculations which is an undesirable side effect of the drug and a

disadvantage of its use.

Suxamethonium consists of two acetylcholine molecules joined by a methyl group. It is

metabolised by plasma cholinesterase (pseudocholinesterase, acetylcholine acylhydrolase)19.

The structural similarity to acetylcholine makes it the neuromuscular blocking agent with a

fast onset of action (30-60 sec).However this similarity is also responsible for its many

adverse effects caused by stimulation of receptors other than the acetylcholine receptors of

the neuromuscular junction such as the muscarinic receptors and receptors in the autonomic

ganglia 1.

Suxamethonium is still the accepted drug for rapid sequence intubation and is a popular

muscle relaxant for ambulatory anaesthesia and short surgical procedures 20. This explains

why this drug has found some importance and is readily available in most theatre suites.

10

Suxamethonium is currently the only widely used depolarising agent for rapid sequence

intubation due to its rapid onset of action, short duration of action and excellent muscle

relaxation. These advantages of suxamethonium as a muscle relaxant in anaesthesiology seem

to outweigh its disadvantages. The pattern of onset of paralysis is in the order of facial, glottic

and pharyngeal muscles which are first affected, followed by arm, leg, trunk muscles; finally

the respiratory muscles and diaphragm are affected 21. The mechanism of action of

suxamethonium can be classified as depolarisation of the motor end plate, agonistic actions at

other nicotinic sites and muscarinic effects. Idiosyncratic actions and drug interactionscan

also occur.

Fasciculationsfollowing suxamethonium use can be vigorous and this may cause

myalgia.Suxamethonium-induced myalgia usually occurs after diffuse uncoordinated

contractions of muscle bundles22. There is often a feeling of muscular stiffness after

consciousness has been regained. It usually lasts fortwo or three days but occasionally

persists for as long as a week. It appears on the first day after surgery and is commonly

described as the pain one might suffer after an unaccustomed degree of physical exercise.It is

commonly located in the shoulder, neck and upper abdominal muscles22.

Postoperative pain is a form of acute pain due to surgical trauma with an inflammatory

reaction and initiation of an efferent neuronal damage. It is a combined constellation of

several unpleasant sensory, emotional and mental experience precipitated by the surgical

trauma and associated with autonomic, endocrine-metabolic, physiological and behavioural

responses 23.

The relationship between fasciculations and postoperative myalgia may not have been well

defined. Pretreatmentwith some pharmacological agents decreases the incidence of

fasciculations significantly as has been reported by Shoroghi and co - workers 24. This is also

11

supported by Spence and colleagues 25 whose work (comparingrocuronium and lignocaine as

pretreatment agents for the prevention of postoperative myalgia after succinylcholine

administration) revealed that pretreatment with lignocaine decreases the occurrence of

fasciculations and may provide better relief from myalgia than rocuronium forty – eight hours

after surgery.Although pretreatment may be said to decrease the occurrence of fasciculations,

the severity of fasciculations has been said to have no direct correlation with the occurrence

of postoperative myalgia 8. Postoperative myalgia could probably be affected by the severity

of pain after surgery and the patient’s tolerance to pain.

The reported incidence of suxamethonium induced myalgia ranges from 1.5-89% although,

the most commonly quoted figure is around 50% 6. The duration of discomfort may vary

depending on the patient involved and may last for 2 or 3 days but occasionally persists for as

long as one week. The occurence and severity of myalgia varies and may be due to a number

of factors such as age, gender and type of surgery26.

Post-operative myalgia is reduced by oestrogens and progesterone 27. Myalgia is therefore

lower in pregnant than in non-pregnant women of childbearing age possibly due to the

influence of progesterone or oestrogens, which are in high circulating levels in the pregnant

than non – pregnant state. Since in pregnancy progesterone is in high circulating levels, it

therefore means that pregnancy can be said to be protective against muscle pains. If this is the

case, then pregnant women who will require tracheal intubation with suxamethonium will not

be expected to experience post - operative myalgia.

In a study by Magee and co-workers 28, muscle fasciculations and pain following the

administration of suxamethoniumwith no pretreatment agent givenwas assessed in a group of

patients (male and female) who performed a series of stretch exercises one hour before

surgical operations. Comparison was made with another group of patients (male and

12

female)who received suxamethonium without a pretreatment agent and who did not have

stretch exercises.It was found that a lower incidence of fasciculations and post-operative

myalgia after suxamethonium use occured with less severity in patients that had performed

stretch exercises. This is likely due to the fact that exercise stretch receptors are progressively

desensitized as the receptor potential adapts under conditions of prolonged slow stretch, with

reduced muscle tone after slow stretching28. It has been suggested that this slow stretching of

receptors causes a reduction in the rate of gamma efferent discharge from muscle spindles

with a modification of the excitability of alpha motor neurones and all these subsequently

increase the threshold for motor units thus altering the action of suxamethonium28. In as

much as this study demonstrated the effect of exercise on suxamethonium induced

fasciculations and myalgia, it may not be feasible for patients to perform exercises before

anaesthesia and surgery. The response obtained in patients who are muscularly fit as a result

of previousconstant exercises may differ from the response obtained in patients who only

performed stretch exercises just prior to surgery.

Lignocaine is an amide local anaesthetic agent and was shown to be an effective pretreatment

agent by Pace 29in a meta- analysis on the use of lignocaine in the prevention of

suxamethonium induced myalgia. Similarly, Tat Leange Lee 30 alsofound lignocaine to be an

effectivepretreatment agent in the prevention of suxamethonium induced myalgias. This

effectiveness of lignocaine in reducing myalgia which occurs as a result of suxamethonium

use is also supported by the work of Raman and colleague 31who concluded that lignocaine

reduces postoperative myalgia. It can therefore be inferred that lignocaine mitigates

suxamethonium induced myalgia. This could be attributed to its membrane stabilising

properties which probably prevents ionic exchange across the cell membrane. However, the

work by Laurence 32showed that lignocaine among other pretreatment agents such as

midazolam and even suxamethonium did not reduce myalgia and concluded that only the non

13

– depolarizing muscle relaxant pretreatment, alcuronium, is effective in reducing some of the

adverse effects of suxamethonium such as increases in myglobin and creatinine kinase levels

and the occurence of postoperative myalgia.

Suxamethonium causes a reduction in serum calcium levels23.This reduction is closely

associated with an influx of calcium into the muscle cells and subsequent development of

muscle pains (myalgia). This reduction in serum calcium enhance the intensity of

fasciculations and muscle fibre contractions and therefore causemuscle spindle damage and

pain subsequently 23. Lignocaine on the other hand restricts the increase in serum potassium

and the decrease in serum calcium 30. This further explains the cell membrane stabilization

properties of lignocaine.

Certain agents used for the induction of general anaesthesia in patients have been found to

alter the occurence of muscle fasciculation following the administration of suxamethonium

intravenously. In a study by Karamaz et al 33, it was found that fasciculation was absent in

20% of patients administered propofol 3.5mg/kg intravenously and the severity of

fasciculation was also significantly lower than in patients who were givenpropofol at 2mg/kg

I.V and thiopentone 5mg/kg. Thus it was concluded that the administration of high dose

propofol at 3.5mg/kg is effective in reducing fasciculations after suxamethonium

administration. This therefore means that the use of propofol will inhibit the occurence of

fasciculations.

In a meta – analysis , following a 95% incidence of fasciculation with thiopentone and 95.2%

with propofol, it was found that lignocaine prevented suxamethonium induced fasciculation

when lignocaine was given prior to the administration of thiopentone and suxamethonium

(group A) and propofol and suxamethonium (group B) and the difference in both was not

statistically significant 7. This shows that lignocaine mitigates suxamethonium - induced

fasciculation.

14

In a study by Shoroghi et al 24 on the effect of thiopentone on the severity and duration of

succinylcholine-induced fasciculation, it was found that patients who received thiopentone

immediately before succinylcholine administration had a decrease in the duration and

severity of fasciculation more than those who had intravenous thiopentone 30seconds before

succinylcholine administration. Thus fasciculations could be reduced by the use of

thiopentone and this in turn reduces the intensity of fasciculations and may be a reduction in

myalgia subsequently.

Other agents have been tried in a bid to reduce fasciculations and post-operative myalgia and

these include oral Dantrolene, Vitamin C, Calcium gluconate, Magnesium, gabapentine and

even suxamethonium 34.

Dantroleneis a hydrantoin derivative originally developed as an antibiotic. It has the ability to

reduce muscle tone by interfering with intracellular calcium release, thus depressing

intracellular calcium transfer. This may thereby decrease the incidence of succinylcholine -

induced myalgia35. This however, may explain its beneficial actions after succinylcholine use

despite lack of changes in serum calcium. Dantrolene also prevents an increase in serum

myoglobin produced after suxamethonium-induced muscle fasciculation due to its peculiar

properties mentioned earlier35. However, oral dantrolene is not easily and readily available in

our clinical setting here in Nigeria.

Calcium gluconate was found to be partly successful in reducing the incidence of myalgia 36.

In the study by Shrivastava and co-workers 37, calcium gluconate was used as a pre-treatment

agent for the prevention of succinylcholine - induced myalgia in patients who were to have an

elective surgery and to ambulate on the evening of thesame day. The patients were divided

15

into two groups of 40 patients each. A test group of 40 patients were given 10ml of 10%

calcium gluconate intravenously immediately before induction of anaesthesia with

thiopentone followed by suxamethonium. The control group of 40 patients was given

thiopentone and suxamethonium without calcium gluconate.It was however observed that the

incidence of post-operative myalgia was significantly less (5%) in the test group than in the

control group (45%).They concluded that calcium gluconate pre-treatment decreases the

incidence and severity of post-operative myalgia. This could be because calcium prevents the

movement of electrolytes across the cell membrane thereby stabilising the membrane and this

in turn is protective against post-operative myalgia.

In one study by Stacey et al38 on magnesium sulphate, it was found that the incidence of

fasciculations was significantly lower in patients who had magnesium pretreatment before

induction of general anaesthesia. This is supported by the study of Kumar and colleagues 39

whose work on the effect of magnesium with propofol for induction of anaesthesia on

suxamethonium - induced fasciculations and myalgia showed that fasciculationsoccured in

only 50% of patients in the magnesium group as against 100% of patients in the normal saline

(placebo) group. Also after 24hrs, no patient in the magnesium group had myalgia but 30% of

patients in the normal saline (Placebo) group had myalgia. They thus concluded that

intravenous magnesium sulphate at a dose of 40mg/kg may be used with propofol for

induction of anaesthesia to control suxamethonium - induced fasciculation and myalgia..

Danladi and co-workers 40worked on 84 adult patients using magnesium sulphate as a

pretreatment agent before induction of general anaesthesia. They found that magnesium

sulphate reduced significantly the severity of fasciculation. They concluded by advocating the

use of magnesium sulphate pretreatment in all patients at risk of this complication. Their

finding therefore is in support of the work by Stacey et al38.

16

These effects of magnesium in reducing fascciculations due to suxamethonium could be

attributed to the action of magnesium sulphate on the neuromuscular junction by competing

with calcium at the pre-junctional site 41. These two ions antagonise each other. Therefore, it

means that high magnesium concentration inhibits release of acetylcholine while high

calcium concentration increases release of acetylcholine from pre-synaptic nerve terminals.

This may therefore explain the control of succinylcholine – induced fasciculations by

magnesium sulphate.

Raman and San 31 using atracurium and lignocaine as pretreatment agents, aimed at

determining the attenuation in the incidence of myalgia, fasciculations and changes in serum

potassium and creatinine kinase concentrations. Atracurium and lignocaine were used in

combination and separately as pretreatment agents before the use of suxamethonium. They

had 80 ASA I patients aged between 20 - 50 years assigned to one of four groups.

Anaesthesia was induced with thiopentone and fentanyl. Group C received placebo

pretreatment before 1.5 mg succinylcholine. Group A received 0.05 mg.kg-1atracurium three

minutes before suxamethonium. Group L had 1.5 mg.kg-1 lignocaine 30 seconds before

suxamethonium while Group AL received both atracurium and lignocaine. Serum potassium

five minutes after succinyl choline and creatinine kinase twenty four hours after operation

was measured and the increases from pre - induction values were compared. Fasciculation

and post - operative myalgia were then recorded. The results from their study showed that

lignocaine and atracurium individually reduce post-operative myalgia, with a further decrease

when they are used together before administration of suxamethonium. This further

emphasizes the ability of lignocaine (cell membrane stabilization) in reducing myalgia. Their

work was also supported by Amornyotin et al 42whose work on the effect of lignocaine

pretreatment on reduction of succinylcholine – induced myalgia in patients undergoing

gynaecological surgery observed that lignocaine reduced post-operative myalgia significantly

17

and they concluded that where suxamethonium is used, lignocaine is proven to be a useful

pretretment agent for reduction of post-operative myalgia.

Gabapentineis another agent that was studied by Pandy and colleagues 43. They aimed at

evaluating the efficacy of gabapentine on the incidence of fasciculation and suxamethonium -

induced myalgia. The patients were to have laparoscopic cholecystectomy and were assigned

into two groups; Group I (gabapentine group) who had 600mg of gabapentine 2hrs before

surgery orally and group II (placebo group) who had nothing. Myalgia was recorded at

24hours. Their results showed that prophylactic use of gabapentine significantly reduced the

incidence and severity of myalgia and they concluded that in laparosopic cholecystectomy,

prophylactic use of gabapentine 600mg reduces the incidence and severity of

myalgia.Gabapentine could therefore be said to be an effective pretreatment agent. This drug

is not readily available in most hospitals in Nigeria.

Suxamethonium has also been used as a pre-treatment agent. This was shown by

Hajimohamadi and co-workers34when they compared atracurium to mini-dose

suxamethonium (5mg) for prevention of muscle fascicuations in a randomised placebo

(Normal saline) controlled study. They had 79 patients and randomised them into 3 groups,

Group I (normal saline), Group 2 (Atracurium), and Group 3 (suxamethonium). Thiopentone

was the standard induction agent which was given 90sec after administration of pre -

treatment agents, followed by intravenous administration of 1.5mg/kg suxamethonium. Their

results showed that 3.8% of patients in group I showed no fasciculations while 30.8% had

mild, 53.8% had moderate and 11.5% had vigorous fasciculations. In group 2, fasciculations

were absent in 74.1% of the patients, while 25.9% of the patients had mild fasciculations. In

group 3, 23.1% of the patients had no fasciculations while 42.3%, 30.8% and 3.8% of the

patients showed mild, moderate and vigorous fasciculations respectively with

suxamethonium pretreatment.Their results however revealed that the incidence and severity

18

of fasciculations were significantly decreased by atracuriumpretreatment but not by

pretreatment with suxamethonium or normal saline placebo. In this regard, suxamethonium

has not proved to be an effective pretreatment agent. It can be inferred from this result, that

the 3.8% of patients in group I that showed no fasciculationsin in their study may not be a

true representative of the ideal situation that is obtainable with suxamethonium. This absence

of fasciculation in patients who had normal saline may be due to administration of potent

analgesics, the ability of some patients to tolerate pain or some other unknown factors.

Although suxamethonium has been in routine use for a long time, the search for an effective

pretreatment agent to reduce suxamethonium induced muscle fasciculation and postoperative

myalgia is still on-going. The mechanism of postoperative myalgia due to the use of

suxamethonium may be complex. This study will focus on the use of lignocaine to prevent

suxamethonium induced fasciculation and postoperative myalgia in a black population.

19

CHAPTER THREE

METHODOLOGY

STUDY LOCATION

This study was conducted in the University of Benin Teaching Hospital, Benin City, Edo

State, Nigeria. Ethical clearance and approval for the study was obtained from the University

of Benin Teaching Hospital Ethical Clearance Committee.

STUDY DESIGN

This is a double blinded, prospective, randomised, placebo-controlled study in adult surgical

patients. The patients did not know the drugs they received and the Anaesthetist

administering the study drugs (lignocaine and normal saline) was different from the

Anaesthetist (researcher) who assessed for post-operative myalgia.

STUDY POPULATION

Patients scheduled for elective surgeries under general anaesthesia were recruited after

informed consent was given.

This included ASA I or II adult patients aged between 18 and 45years, with a Body Mass

Index (BMI) of not more than thirty scheduled for elective surgery lasting not more than four

hours duration under general anaesthesia.

RANDOMIZATION

A simple random sampling methodwas done by computer generation and patients were

assigned to two groups of 76 patients each by opening unmarked sealed envelopes indicating

the induction regimen as follows;

Group I : intravenous normal saline (6mls), thiopentone sodium (thipen-1®, batch number

2TPNO5,Samart Life Sciences PVT Limited, Mumbai) and suxamethonium (suxamethonium

chloride injection BP 100mg, batch number 10522, RotexMedica ,Trittau, Germany).

20

Group II : intravenous Lignocaine 1% ( liga® (6mls), batch number SL 301205, Geneith

Pharmaceuticals, Lagos, Nigeria) , thiopentone sodium (thipen-1®, batch number 2TPNO5,

Samart Life Sciences PVT Limited, Mumbai) and suxamethonium (suxamethonium chloride

injection BP 100mg, batch number 10522, RotexMedica, Trittau, Germany).

The sample size was calculated as shown below.

SAMPLE SIZE

The study sample size was calculated using the formula below 44

n = z2pq

d2

Where:

n = desired sample size

Z = the standard normal deviate, usually set at 1.96

P = prevalence/ incidence of fasciculation

q =1.0 - p

d = degree of accuracy desired, usually set at 0.05

n = (1.96) 2 x 0.9 x 0.1

(0.05) 2

= 138.2976

= ~ 138

Drop outs = 10% of 138 =14. Allowing a 10% increase for attrition

Thus sample size =138 + 14 = 152

That means 152 patients were included in this study. Each group thus had 76 patients

allocated by random selection.

21

INCLUSION CRITERIA

• One hundred and fifty-two ASA I or II patients.

• Patients aged between 18 and 45 years.

• Patients with a body mass index (BMI) of not more than thirty.

• Patients scheduled for elective surgery and requiring general anaesthesia and tracheal

intubation.

• Surgery lasting not more than four hours.

EXCLUSION CRITERIA

• Patient refusal.

• Patients with a BMI greater than thirty.

• Patients with general body pains.

• Patients unable to understand written and / or verbal information.

• Known allergy to local anaesthetic agents.

• Patients at risk of Malignant Hyperthermia.

• Patients with past history of difficult intubation, potential difficulties for tracheal

intubation, obvious anatomical abnormality as regards mouth opening, neck flexion

and Mallampati score >2.

• Patients with intercurrent medical illnesses like cardiovascular disease (e.g

hypertension, existing dysrrhythmias, myocardial or coronary artery disease), asthma.

• Patients with a pulse rate less than sixty beats per minute.

• Patients with or at risk of a raised intra-cranial and intra- ocular pressures.

• Pregnant patients.

• Patients that have suffered some degree of burns.

22

PATIENTS AND METHODS

Eligible patients were identified and the study procedure explained in detail to them and

written consent obtained.

Pre-operative review of patients scheduled for elective surgery was done by the researcher. A

detailed general examination for pallor, jaundice, cyanosis, dehydration and bilateral pedal

oedema was carried out. A thoroughsystemic examination of the cardiovascular

andrespiratory systems, including airway examination was done. Also abdominal,urogenital

and central nervous system examinationswere done and findings recorded.

Routine investigations like haemoglobin concentration, full blood count, urinalysis,

electrolytes and urea were done for every patient. All patients were fasted overnight and

premedicated with oral diazepam (10mg) the night (10pm) before and in the morning of

surgery (6am) with a sip of water.

In the pre-operative period, data on baseline level of myalgia on a 4 point myalgia scale was

collected with a score of none, mild, moderate, and severe myalgia.

Before patients arrival in the theatre, anaesthetic machine check for functionality was done,

endotracheal tubes of various sizes to include appropriate size, one size below and above the

appropriate size, laryngoscopes, suction machines, stylettes, laryngeal mask airway, face

mask and resuscitation drugs like atropine, ephedrine, adrenaline, and cold ice packs were

provided. Dantrolene was not available in this hospital.

On arrival in the operating room, each patient had an Edan multi-parameter monitor attached.

Baseline pulse rate, temperature, non - invasive blood pressure, mean arterial pressure

(MAP), oxygen saturation, ECG and respiratory rate were obtained and recorded. The heart

23

rate and blood pressure of each patient was monitored using a non-invasive procedure

subsequently. Drug withdrawal in appropriate syringes was done by one anaesthetist

(researcher) while drug administration and rating of fasciculations was done by a second

anaesthetist who was otherwise uninvolved in the study and blinded to the type of drug

contained in the syringes.

Administration of 1% Lignocaine 6mls (60mg) was done using appropriately numbered

syringes and saline placebo given was of equal volume (6mls) as that of the lignocaine

contained in the syringes. The time at pretreatment with lignocaine or saline was considered

time zero (0) for data collection purposes.

Two minutes after pretreatment administration, anaesthesia was induced with thiopentone

sodium (4mg/kg). After administration of thiopentone sodium, suxamethonium 1.5mg/kg was

given intravenously thereafter and each patient was observed for the presence or absence of

fasciculations using a numeric rating scale ranging from 0 through 345(see Appendix III). The

duration of muscle fasciculation was done by visual observation of when fasciculation was

first noticed and when it stopped and this was timed and recorded.

Post-operative myalgia was assessed 1hr, 12hrs, 24hrs and 48hrs after surgery using a

structured questionnaire and graded on a four point scale by the anaesthetist (researcher)

blinded to the patient study group (see Appendix IV). All questionnaires used in this study

were securely stored in files and also stored as files in data bank in a computer for safe

keeping / confidentiality. The computer had a password known only by the researcher and

safeguarded from any form of entry by selecting appropriate codes known only by the

researcher. Only the researcher had access to the computer.

24

PERIOD OF STUDY

This study was conducted over a period of three months.

DATA ANALYSIS

Data entry and analysis was done using the Statistical Package for the Social Sciences (SPSS)

16.0 software (Chicago Illinois, USA). Independent student t-test was used to test for

significant difference in the two groups for the various continuous variables such as age,

height, and weight.

The intensity of postoperative myalgia at 1, 12, 24 and 48hrs was compared between groups

with Chi square (X2) analysis.

The presence or absence of fasciculations between groups was compared using the Fischer

exact test.

A p-value <0.05 was considered significant.

25

CHAPTER FOUR

RESULTS

One hundred and fifty two ASA I and II patients, 61(40.1%) malesand 91(59.9%) females

were studied.

There was no statistically significant difference between the groups with regards to age (p =

0.194) and weight (p = 0.087) as shown in Table I. There was a statistically significant

difference between both groups with regards to height (p = 0.010) and Body Mass Index

(BMI) (p = < 0.001) as shown in Table I.

Group I had more of normal weight patients (53.3%), while Group II had more of patients

who were overweight (75%) (Table II).There was a statistically significant difference

between the groups with regards to those patients who were of normal weight (p ˂ 0.0001)

and overweight (p˂0.0001) as shown in Table II. There was no statistically significant

difference between the groups in patients who were underweight (p=0.62) (Table II).

Muscle fasciculationsoccured in all the 76 (100%) patients in Group I and only 59(77.6%)

patients in Group II as shown in Table III. They were absent in 17 (22.4%) patients in Group

II.They were more of moderate intensity in both groups [Group I (60.5%) and Group II

(43.4%) (p=0.05)]. There was a statistically significant difference in the intensity of muscle

fasciculations between the groups with regards to absent fasciculations (p˂0.001), mild

fasciculation (p˂0.001) and severe (p˂0.001) (Table III). Severe fasciculations occurred in

27(35.5%) patients in Group I and 9(11.8%) patients in Group II (Table III).

26

Fasciculations of moderate intensity occuredmore in the age range between 31 - 40 years in

both groups- Group I had 28(60.9%) patients and group II had 19(57.6%) patients (p = 0.09)(

Table IV).

Fasciculations were present in 39 (100.0%) males in Group I and 20 (91%) males in Group II

as shown in Table V. Fasciculations were also present in all 37 (100%) females in Group I

(100%) and 39 (72.2%) females in Group II.

The duration of fasciculations is shown in Table VI. Group I had a longer duration of

fasciculations (17 ± 2.95 seconds) than Group II (13 ± 7.95 seconds) but this was not

statistically significant (p=0.999).

After 24 hours, post–operative myalgia was present in 5 (6.6%) patients in Group I and 3

(3.9%) patients in Group II (p=0.619). It was absent in 71 (93.4%) patients and 73 (96.1%)

patients in Group I and Group II respectively- p= 0.906 (Table VII). All the patients who had

post-operative myalgia in both groups had the pain confined to one location (Grade 1).

Out of the total number of patients who had myalgia in Group I, 3(60%) were males while 2

(40%) were females. Of those who had myalgia in Group II, 2 (67%) were males while

1(33%) was female. (Table VIII).The difference between the number of males who had

myalgia in both groupsand the number of females who had myalgia in both groups was not

statistically significant (p=1.000 and p=1.000 respectively).

There were no post – treatment complications with lignocaine - suxamethonium

combinationsuch as hypotension or bradycardia. There was also no complication noticed after

the administration of normal saline and suxamethonium combinatione.g.masseter spasm.

The variations in systolic blood pressure after the administration of thepretreatment agent in

Group I and Group II is shown in Figure 1.In Group I, there was a rise in the systolic blood

27

pressure 5minutes after pretreatment agent administration but this rise latter approached the

baseline value at10 minutes. In Group II, there was a drop in the systolic blood pressure from

the baseline value at 5 minutes after the administration of the pretreatment agent. However 10

minutes after pretreatment administration, the systolic blood pressure increased to approach

the baseline value.

Figure 2 shows the variation in the diastolic blood pressures in both groups. There was a rise

in the diastolic blood pressure from the baseline value in Group I and a drop from the

baseline value in Group II 5minutes after giving the pretreatment agent. However, both

groups had a value that approached the baseline value 10minutes later.

The mean arterial blood pressures in both groups are shown in Figure 3. There was a rise in

the mean arterial pressure after 5 minutes of administering the pretreatment agent but this

value dropped in Group II. After 10 minutes, both groups had a value that approached the

baseline mean arterial pressure.

The variations of the pulse rate in both groups after the administration of the pretreatment

agent is shown in Figure 4. Both groups had values which were the same in the first minute

but after 5minutes, the pulse rate of patients in Group I increased from 98bpm to 110bpm.

After 10minutes, the pulse rate of Group I patients dropped to the initial baseline level. There

was no change in the pulse rate of Group II patients after the administration of the

pretreatment agent as it remained constant.

The arterial oxygen saturation in Group I and Group II is shown in Figure 5. After the

administration of the pretreatment agent, patients in Group I had no change in their arterial

oxygen saturation after 5 minutes but 10minutes later, there was a drop to a value below that

28

of the baseline value. However in Group II patients, the SpO2 dropped in value below the

baseline value after giving the pretreatment agent. This value increased in 10minutes to

values above the baseline.

29

Table I: SOCIO – DEMOGRAPHICAND ANTHROPOMETRIC MEASUREMENTS

OF GROUP I AND GROUP II

VARIABLES

GROUP I

n = 76

n (%)

GROUP II

n = 76

n(%)

p-value Level of

significance

Age group(years)

≤ 20 0 (0.0) 3 (100.0)

21-30 12 (52.2) 11 (47.8)

31-40 43 (47.3) 48 (52.7)

41-50 21 (60.0) 14 (40.0) 0.194 ns

Sex

Male 39(63.9) 22(36.1)

Female 37(40.7) 54(59.3)

Anthropometric

measurements

Mean ± S.D

Mean ± S.D

Weight (Kg) 65.14±6.12 66.84±5.99 0.087 ns

Height (meters) 1.59±0.09 1.57±0.03 0.010 s

BMI (Kg/m2) 23.94±4.74 27.26±1.90 <0.001 s

30

Table II: BODY MASS INDEX OF GROUP I AND GROUP II.

GROUP

BMI I II TOTAL p-value Level of significance

n (%) n (%) n (%)

Under Weight 3 (3.9) 5(6.6) 8 (10.5) 0.619ns

Normal Weight 42 (55.3) 14 (18.4) 56 (36.8) ˂0.0001 s

Over Weight 31 (40.8) 57 (75.0) 88 (115.8) ˂0.0001 s

Total 76 (100.0) 76 (100.0)

31

Table III: INTENSITYAND OCCURENCE OF FASCICULATIONS IN GROUP I AND

GROUP II

Intensity of

Fasciculation

Group I

n = 76(%)

Group II

n = 76(%)

Total P-value Level of

Significance

Absent 0(0.0) 17(22.4) 17(22.4) <0.001 s

Mild 3(3.9) 17(22.4) 20(26.3) <0.001 s

Moderate 46(60.5) 33(43.4) 79(103.9) 0.056 ns

Severe

TOTAL

NO.THAT

FASCICULATED

(OCCURENCE)

27(35.5)

76 (100.0)

9(11.8)

59(77.6)

36(47.3)

<0.001 s

32

Table IV: INTENSITY OF FASCICULATIONS IN VARIOUS AGE GROUPS IN

GROUP I AND GROUP II

Intensity of

fasciculation

Age group

(years)

Group I

n(%)

Group II

n(%)

p-value Level of

significance

Absent <20 0(0.0) 0(0.0) - -

21-30 0(0.0) 6(35.3) <0.002 s

31-40 0(0.0) 8(47.1) <0.001 s

41-50 0(0.0) 3(17.6) 0.100 ns

Total 0(0.0) 17(100.0) <0.001 s

Mild <20 0(0.0) 0(0.0) - -

21-30 3(100.0) 0(0.0) 0.100 ns

31-40 0 (0.0) 17(100.0) <0.001 s

41-50 0(0.0) 0(0.0) - -

Total 3(100.0) 17(100.0) <0.001 s

Moderate <20 0(0.0) 0(0.0) - -

21-30 6(13.0) 5(15.2) 1.000 ns

31-40 28(60.9) 19(57.6) 0.098 ns

41-50 12(26.1) 9(27.3) 0.585 ns

Total 46(100.0) 33(100.0) 0.056 ns

Severe <20 0(0.0) 3(33.3) 0.100 ns

21-30 3(11.1) 0(0.0) 0.100 ns

31-40 15(55.6) 4(44.4) 0.001 s

41-50 9(33.3) 2(22.2) 0.009 s

Total 27(100.0) 9(100.0) <0.001 s

33

Table V:OCCURENCE OF FASCICULATIONS IN MALES AND FEMALES IN


Occurenceof Fasciculation

Sex Group I Group II

n(%) n(%)

p-value

Male 39 (100) 20 (90)

Female 37(100) 39(72)

Total 76 (100.0) 59(77.6)

34

Table VI:DURATION OF FASCICULATION IN GROUP I AND GROUP II

FREQUENCY (%)

Time Group I Group II p-value Level of significance

(sec) n (%) n (%)

≤10 6 (7.9) 0 (0.0)0. 002s

11-15 6 (7.9) 17 (28.8) 0.003 s

16-20 58 (76.3) 32 (54.2) ˂0.001 s

21-25 6 (7.9) 8 (13.6) 0.706 ns

26-30 0 (0.0) 2 (3.4) ˂0.333 ns

Mean time (sec) 17 ± 2.95 13 ± 7.95 0.439ns

35

Table VII: OCCURENCE OF POST-OPERATIVE MYALGIAIN GROUP I AND

GROUP II

Time Post-opGroup I Group II p-value Level of significance

(hrs) myalgia n (%) n (%)

1 Yes 0 (0.0) 0 (0.0) - -

No 0 (0.0) 0 (0.0) - -

12 Yes 0 (0.0) 0 (0.0) - -

No 0 (0.0) 0 (0.0) - -

24 Yes 5 (6.6) 3 (3.9) 0.619ns

No 71(93.4) 73 (96.1) 0.906 ns

48 Yes 0 (0.0) 0 (0.0) - -

No 0 (0.0) 0 (0.0) - -

TOTAL 76(100.0) 76 (100.0)

36

Table VIII: SEX DISTRIBUTION AND OCCURENCE OF POST – OPERATIVE

MYALGIA IN GROUP I AND GROUP II

Post – op myalgia Group IGroup II p-value level of significance

n (%) n(%)

Male3(60) 2(67)1.000ns

Female2(40)1(33)1.000ns

Total 5 (100) 3 (100)

37

BL= Baseline

Figure 1: BASELINE AND POST-TREATMENT CHANGES IN SYSTOLIC BLOOD

PRESSURE IN GROUP I AND GROUP II

105

110

115

120

125

130

135

140

145

BL 1min 5min 10min

Syst

oli

c b

loo

d p

ress

ure

(mm

Hg)

Time (mins)

GROUP I

GROUP II

38

BL= Baseline

Figure 2: BASELINE AND POST-TREATMENT CHANGES IN DIASTOLIC BLOOD


72

74

76

78

80

82

84

86

88

90

92

BL 1min 5min 10min

Dia

stoli

c b

lood

pre

ssu

re(m

mH

g)

Time (mins)

GROUP I

GROUP II

39

BL= Baseline

Figure 3:BASELINE AND POST-TREATMENT CHANGES IN MEAN ARTERIAL


80

85

90

95

100

105

110

BL 1min 5min 10min

MA

P(m

mH

g)

Time (mins)

GROUP I

GROUP II

40

BL= Baseline

Figure 4:BASELINE AND POST-TREATMENT CHANGES IN PULSE RATE IN


0

20

40

60

80

100

120

BL 1min 5min 10min

Pu

lse

Rate

(B

eats

per

min

)

Time (mins)

GROUP I

GROUP II

41

BL= Baseline

Figure 5:BASELINE AND POST-TREATMENT CHANGES IN SpO2 IN GROUP I

AND GROUP II

96

96.5

97

97.5

98

98.5

99

99.5

100

BL 1min 5min 10min

Sp

O2(%

)

Time (mins)

GROUP I

GROUP II

42

CHAPTER FIVE

DISCUSSION

This study showed that the administration of intravenous lignocaine prior to intravenous

suxamethonium was associated with a modestreduction in muscle fasciculations. Patients

who had lignocaine had a lower incidence of muscle fasciculations (77.6%) compared to

those who had placebo where all the patients had muscle fasciculations (100%).

This incidence of fasciculations observed in this study in patients who had placebo, is similar

to that reported by Kumar and colleagues 41, where the incidence of fasciculations in controls

was 100%. Nighat and colleagues48also had a 100% incidence of fasciculations in controls. In

this study, the incidence of fasciculations was reduced from 100% to 77.6% after the use of

lignocaine pre-treatment. Hence lignocaine reduced the occurence of muscle fasciculations.

Pre-treatment with lignocaine may also have affected the intensity of muscle fasciculations;

muscle fasciculations amongst patients in Group II were more of mild to moderate in

intensity compared to Group I where the intensity was mostly moderate to severe.

Age may also have affected the occurrence and intensity of fasciculations in patients

recruited into this study. Muscle fasciculations wereobserved to be more in patients within

the age group of 31-40 years than in younger (21-30 years) and older (41-50 years)

patients,in both groups.Fermontet al14observed that older adults had more fasciculations than

younger adults.His study was however among healthy adults with benign fasciculation

syndrome who did not receive suxamethonium. Amongst patients in Group I,

severefasciculations occured more in those within the 31-40 age group compared with the

21-30 age group and 41-50 age group. Suxamethonium induced fasciculations may occur

43

more in thosewho may engagemore in physical activities. The musclesof these individuals

may therefore have anamplified response to suxamethonium due to more musclestress from

excessiveexercise. This may not be so in older adults.

The duration of muscle fasciculations in patients who had placebo was found to be longer

compared to those patients who had lignocainebut this difference was not statistically

significant. Shoroghi and colleagues 24reported that pre-treatment before suxamethonium use

reduces the duration and severity of muscle fasciculations which supports what was obtained

in this study. It can therefore be inferred that pre-treatment with lignocaine has a role in the

reduction of the duration of suxamethonium induced fasciculations. This observation could

serve as a pointer to the important role of lignocaine as a pre-treatment agent.

Weight was found to affect the occurrence of muscle fasciculations in this study. Muscle

fasciculations were observed to occur more in normal weight and overweight patients in the

study group copared with the placebo. It is possible that normal and overweight patients have

a greater muscle mass and muscular fitness with less fat than obese patients. Increased

muscle mass and fitness may affect the occurence of suxamethonium induced muscle

fasciculations.44, 48 .

In this study, postoperative myalgia was found to occur more in patients who had placebo

(6.6%) than in those patients who had lignocaine (3.9%). This difference was however not

statistically significant.In the study by Ahsanand colleagues41, following a 90% incidence of

suxamethonium induced fasciculations in the normal saline group (without the use of a pre-

treatment agent),30%of patients had postoperative myalgia. This incidence was quite high

compared with what was obtained in this study.

44

Most patients in both study groups did not have post-operative myalgia. Mingus et al50

reported that postoperative myalgia appears to be unrelated to the use of suxamethonium. In

this study, 96.1% of patients who had lignocaine had no postoperative myalgia compared to

93.4% who had placebo, this difference was not statistically significant. It can be inferred that

the incidence of myalgia obtained in this study, despite the use of lignocaine, may be

explained bearing in mind what Mingus et al 49reported.Conversely, Melnick et al50found that

the administration of intravenous lignocaine prior to suxamethonium was effective against

postoperative myalgia. They reported a reduction in postoperative myalgia of 45%.

Postoperative myalgia was found to occur more in males than in females. The occurrence of

postoperative myalgia could be related to the incidence of fasciculations, muscle mass and

physical fitness. A different finding was reported by Nighat et al 48, who noted a higher

incidence of postoperative myalgia in females compared to males. Their study however, had

a higher occurrence of fasciculations in males compared to females. If the degree of muscle

fasciculations is related to the occurrence of postoperative myalgia, it is expected that males

should have a higher incidence of postoperative myalgia. The reason for the result by Nighat

et al 48 is therefore difficult to explain. However, from the findings obtained in this study as

regards the higher incidence of fasciculations and postoperative myalgia in male patients, it

can be inferred that the incidence of fasciculations may have a correlation with the occurence

of postoperative myalgia even if this has been refuted by Wong and colleagues 6.

In this study,following the administration of suxamethonium, patients who had placebo

showed a rise in the systolic blood pressure, diastolic blood pressure and the MAP valuefrom

the baseline value at 1minute and up to 5minutes.On the contrary,among the patients who had

lignocaine, there was a decrease at one minuteand up to 5minutes in the systolic blood

45

pressure, diastolic blood pressure, the mean arterial pressure andthe pulse rate. The rise in the

systolic, diastolic and mean arterial blood pressure among the placebo group could be

attributed tothe fact that usually laryngoscopy and endotracheal intubation is associated with

a pressor response which results in an increase in haemodynamic parameters.There may also

be occasional dysrhythmias, cough reflexes, increased intracranial pressure and intraocular

pressure 51. If no specific measures are taken to prevent these haemodynamic responses, the

heart rate and systolic blood pressure can increase depending on the method of induction.

Among patients in the study group, the haemodynamicresponse may have been attenuated by

lignocaine administration.This finding is supported by the work of Noorai and colleagues 52,

who showed thatlignocaine, attenuated the increase in haemodynamic parameters.Among

various agents, lignocaine has been shown to be popular for the attenuation of the pressor

response to laryngoscopy and endotracheal intubation. In a study by Yorukoglu and

colleagues 53, they showed that if lignocaine is given before laryngoscopy, it can blunt the

increase in heart rate, systolic blood pressure, mean arterial pressure and cathecolamine levels

associated with intubation. This results in a drop in the haemodynamic parameters which is

similar to what was obtained in this study. Hassani and colleagues 54 also demonstrated that

the infusion of 1.5 - 2mg/kg of lignocaine from the first to the second minute before

laryngoscopy can blunt the increase in heart rate, systolic blood pressure, MAP and

cathecolamine levels associated with intubation. In this study laryngoscopy and endotracheal

intubation was performed two minutes after administration of the pre-treatment agents, with a

resultant drop in the haemodynamic parameters at the fifth minute in those who had

lignocaine. This finding is in keeping with the onset of action of lignocaine which is about

three tofive minutes 53; thereafter it began to wane off and the systolic and diastolic blood

46

pressures, the heart rate and MAP start rising to approach the baseline level as is observed in

the tenth minute in this study.

At the tenth minute, the systolic blood pressure, diastolic blood pressure, mean arterial

pressure and heart rate had approached the baseline valuesin the patients that had placebo. It

can be presumed that the pressor response to laryngoscopy and tracheal intubation had

subsided hence the reduction in the post treatment systolic and diastolic blood pressures,

MAP and heart rates values.

Miller and colleagues 55however, reported that intravenous lignocainefailed to control the

haemodynamic responses following laryngoscopy and endotrachealintubation. Their finding

is contrary to what was obtained in this study. This controversy may be referred to the

importance of timing of lignocaine administration. Considering the mechanism of action of

lignocaine, inhibiting the sympathetic response associated with tracheal stimulation appears

to result from an increased threshold for airway stimulation, central inhibition of sympathetic

transmission and direct depression of cardiovascular responses 51. Notably, the essential

factor of timing should always be taken into consideration when lignocaine is administered as

an attenuating agent to prevent the haemodynamic responses following laryngoscopy and

intubation.

Regarding the effects of lignocaine on blood pressure responses, this study showed that

administration of lignocaine (60mg) before intubation resulted in decreased systolic and

diastolic blood pressures, MAP and heart rate in comparison with the placebo (normal

saline).

47

CONCLUSION

The occurrence of fasciculations is affected by age, weight, and sex of the patient. Patients

who were pre-treated with lignocaine had reduced duration of fasciculations and post-

operative myalgia.

LIMITATIONS OF THE STUDY

In this study, fasciculations were observed visuallyand assigned to be mild, moderate or

severe using a scale and recorded. Such observation is subjective. We measured fasciculation

(an objective variable) instead ofmeasuring increases in myoglobin level and creatinine

phosphokinase (objective variables) because the laboratory in the hospital had problems

procuring the test kits used in measuring these parameters.

RECOMMENDATION

In situations where suxamethonium is the only available short acting muscle relaxant for

endotracheal intubation, lignocaine can be administered as a pre-treatment agent prior to the

administration of suxamethonium to reduce suxamethonium- induced fasciculations. This is

because pre-treatment with lignocaine can provide a reduction in the occurrence and duration

of muscle fasciculations. Also, lignocaine is cheap and readily available.

48

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55

APPENDIX I

56

APPENDIX II

57

APPENDIX III

ASSESSMENT OF THE PRESENCE AND EXTENT OF FASCICULATIONS 47

Grade Characterization

0= Absent No fasciculation

1=mild Fine fasciculation of eyes, face, neck, or fingers but without trunk or

limb movements

2=moderate Fasciculation involving limbs and/or trunk

3=severe Fasciculation with movement of one or more limbs and/or trunk

requiring forceful

retention

DURATION OF FASCICULATION (seconds) =

58

APPENDIX IV

ASSESSMENT OF POST - OPERATIVE MYALGIA

NO

YES

1. Do you have pains, aches or stiffness in your muscles apart from the site of surgery?

2. If yes, where is the location of the pain (e.g neck, shoulder, arm throat, abdomen, buttocks)

......................................................................................................................................................

......................................................................................................................................................

2a. Grade 1................... If pain is confined to one location

Grade 2................... If pain affects more than one location but of moderate

intensity.

Grade 3.................... If pain affects more than one location but of severe

intensity.

YES

NO

3. Does the muscle pain restrict your normal activity?

4. Can you get out of bed?

5. Can you cough without distress or pain?

NO

YES

6. Are you able to turn your head?

If the answer is yes,

: myalgia is graded 2 = moderate (pain affecting more than one site and not causing

disability).

: myalgia is graded 3 = severe (pain affecting more than one site and causing disability).

59

APPENDIX V

PATIENT INFORMED CONSENT

Dear Patient,

You are being requested to participate in this study. You have a choice to participate in this

study or not to participate in it. Detailed information about the study will be discussed with

you by the investigator and upon your understanding of the study, you will be asked to sign

this consent form if you wish to participate in the study.

The study being proposed to you is on the effect of pretreatment with intravenous lignocaine

on suxamethonium induced fasciculation and post-operative body pains.

The study is designed to analyse the effect of intravenous lignocaine in preventing

suxamethonium induced fasciculation and body pains after surgery.

Statement of Confidentiality: The information provided in this study shall be treated with

utmost confidentiality.

Benefits: The study when completed shall be of immense benefit and will help determine if

lignocaine can be used to prevent fasciculation and postoperative body pains after routine

tracheal intubation following elective surgery.

Risks: There are minimal complications from the use of lignocaine and suxamethonium for

tracheal intubation and when used at safe doses (as in this study), the incidence of

complications such as bradycardia will be minimal.

I have read the above statement and was able to ask questions and express concerns which

have been satisfactorily responded to by the investigator. I hereby give my free informed

consent to participate in the study.

Name and signature / thumb print of subject

………………………..Date……………….

Name and signature of investigator

………………………Date…………………..

Name and signature of witness

………………………Date…………………

60

APPENDIX VI

DATA COLLECTION FORM

EFFECT OF INTRAVENOUS LIGNOCAINE COMPARED WITH NORMAL SALINE

PLACEBO IN PREVENTING SUXAMETHONIUM - INDUCED FASCICULATION AND

MYALGIA IN SURGICAL PATIENTS

Name of patient……………………………………………………………

Age………………………………………..Hospital no…………………...

Sex…………………………………………Date………………………….

Weight……………………………………………………………………..

Height………………………………………………………………………

BMI…………………………………………………………………………

ASA Status………………………………………………………………….

Inter-current Medical Disease……………………………………………….

Drug Therapy……………………………………………………………….

Mallampathi Score…………………………………………………………..

Preoperative Investigations:

FBC: Hb /PCV………..WBC…………………….Platelets…………………

E & U & Cr: Na………K……….Cl………HC03 ………Ur………Cr………

Chest X-ray: Normal……………………..Abnormal………………………

ECG: Normal……………………Abnormal……………………………….

Premedication Drug & Dose………………………………………………..

Indication for Surgery……………………………………………………….

Type of Surgery……………………………………………………………..

61

Pretreatment / Preoperative vital Signs:

Blood pressure (MAP)……………...Pulse……………Sp02 ………………

Treatment group…………………………………………………………..

Post Pretreatment vital signs:

1 min: Blood pressure (Systolic/diastolic)…………mmhg

(MAP)……………..Pulse………………Sp02 ……

2 min: Blood pressure (Systolic/diastolic)……………………mmhg

(MAP)……………..Pulse…………….....Sp02 ……

5mins: Blood pressure (systolic/diastolic)………mmhg

(MAP)……………..Pulse………………..Spo2


(MAP)……………..Pulse………………..Spo2


(MAP)……………..Pulse………………..Spo2

15mins: Blood pressure (systolic/diastolic)……….mmhg

(MAP)……………Pulse…………………Sp02

20mins: Blood pressure (systolic/diastolic)…………..mmhg

(MAP)……………Pulse…………………Sp02

Post Pretreatment :

Complications (if any)………………………………………………………..

Management…………………………………………………………..

Post Suxamethonium complications:

62

Bradycardia……………………..Hypotension…………………….

Others…………………………………………..

Management……………………………

Laryngoscopy / Intubation:

Successful……………………… Failed…………………………...

Complications………………………………………………………

Management………………………………………………………..

Post Laryngoscopy /intubation vital signs:

1 min: Blood pressure (systolic/diastolic)……………………..mmhg

(MAP)……………..Pulse………………Sp02 ……

3 min: Blood pressure (Systolic/diastolic)…………………mmhg

(MAP)……………..Pulse…………….....Sp02 ……

5min: Blood pressure (systolic/diastolic)……….................mmhg

(MAP)………………Pulse………………Sp02

Intra-operative complications (if any)

………………........................................................................................

Management of complication ………………………………………

Postoperative complications (if any) :

At 1hr……………………………………………

At 24 hr....................................................................

At 48 hr .....................................................................

Management of complication ………………………………………………

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