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Thesis Full PDF
Thesis Full PDF
NEW DELHI
SUBMITTED BY
DR. JAYAPRAKASH . K
DEPARTMENT OF ANAESTHESIOLOGY
under direct guidance and supervision of Dr. RAJANI SUNDAR M.D., D.A during the
DR. RAMKUMAR RAGUPATHY, M.S., MCH DR. RAJANI SUNDAR, M.D., D.A.,
DEAN CHIEF ANAESTHESIOLOGIST
GKNM HOSPITAL, COIMBATORE DEPARTMENT OF ANAESTHESIA
GKNM HOSPITAL, COIMBATORE.
i
DECLARATION BY THE CANDIDATE
is a bonafide and genuine research work carried out by me under the guidance of
Dr.Jayaprakash K
Date:
Postgraduate in Anaesthesiology
ii
Acknowledgement:
I would like to thank the Consultants and residents of the Department of Obststrics
and Gynaecology for their unwavering support for this study.
I am extremely thankful to the staff nurses of our labour theatre who helped me a lot
during this study.
I would like to thank my fellow post-graduates for their help during the course of this
study.
I thank Dr.Saleendran for his valuable help in completing the statistical analysis and
timely attention in compiling this manuscript.
I would finally thank my mother Mrs.Vasanthi and my wife Dr.Surya for supporting
me through all my endeavours.
Last but not the least, a special thanks to the patients who participated in this study.
Dr.Jayaprakash.K
iii
List of Abbreviations
BP - Blood pressure
cm - Centimetre
EEG - Electroencephalogram
FD - Fetal distress
h/hr - Hour
HR - Heart rate
IV - Intravenous
Kg - Kilogram
mcg/µg - Microgram
iv
MF- Failure of maternal bearing down
mg - Milligram
ml - Millilitre
mm - Millimetre
Numb - Numbness
RR - respiratory rate
Rx - Treatment
Temp - temperature
v
Abstract:
Topic:
labour epidural analgesia. In our study we compared the analgesic efficacy, motor
blocking property and the effect on various labour outcomes of ropivacaine with
Methodology:
Epidural analgesia was performed with a 18G Tuohy needle and a 20G
epidural catheter was placed in the best interlumbar space between L 1 and L4.
pain score) and complications if any were recorded every 15 minutes in the 1st hour,
every 30 minutes in the 2nd hour and every hour later on.
All data were collected and statistical analysis performed using SPSS
Results:
vi
There was no significant difference in the hemodynamics, pain relief, motor
and bupivacaine.
Conclusion:
From this study it can be concluded that though ropivacaine is less potent
vii
LIST OF TABLES
ANALGESIA
ANALGESIA
BOTH GROUPS
PRESSURE
PRESSURE
viii
List of Figures
5. STRUCTURE OF ROPIVACAINE 42
8. STRUCTURE OF FENTANYL 62
9. EPIDURAL OPIOIDS 63
ix
Table of Contents
x
Introduction
Labour is a word that signifies one of the most happiest as well as one
of the most painful moments in a woman's life. If not dealt with properly, it can
and personal process for every woman. Not every woman wants or needs
prenatally about labour and various modalities available for helping her. The
decision to receive any form of pain relief should be the patient's informed
decision.
indicated."1
Pain relief during labour has always been associated with religious &
1
This lead clergymen of those bygone eras to insist that suffering in
labour was consistent with divine intent, since it was god's punishment to Eve
The first documented incident of pain relief during labour in USA was
for Fanny Longfellow in1847 with ether.2 The second woman to become
famous was Emma Darwin, wife of the eminent naturalist Charles Darwin who
was administered chloroform during labour. But the third incident influenced
deliver Prince Leopold on April 7,1853. 2 This made pain relief in labour
from the days of ether and chloroform in 1847 to the present day practice of
medicine.
From 1840s to 1960s, different methods of pain relief were tried. This
Most would agree that the ideal analgesic would be safe for the mother
and newborn, would have minimal effects on the progress of labor, and would
acupuncture. Though they provide some form of pain relief, usually it is not
adequate and patients need additional form of pain relief. These methods
usually are unreliable and not consistent in the pain relief they provide.
Both these agents produce analgesia but not in a continuous and effective
manner. They also have systemic side effects on both the mother and fetus.
turn comprises both regional blocks and central neuraxial blocks. Though
regional blocks give good pain relief they are associated with technical
research in this field has lead to great development in the safe and effective
3
shift in obstetrical anesthesia, thinking away from a simple focus on pain relief
analgesia and the gold standard technique for pain control in obstetrics that is
neuraxial techniques.4
epidural block
provides a more rapid onset of analgesia with little motor blockade. The pain
relief starts sooner and also lasts longer than either drug alone. It allows both
the drugs to be used in lower concentration, thereby reducing the risk of local
5
AIMS & OBJECTIVES:
Aim:
The aim of the study was to compare the efficacy of ropivacaine with
epidural analgesia.
Objectives:
Pain relief
Motor block
Duration of labour
Mode of delivery
- Cesarean section
6
PHYSIOLOGY OF LABOUR PAIN
Labour11- Series of events that take place in the genital organs in an effort to
expel the viable products of conception out of the uterus through the vagina.
1st Stage- Onset of true labour to complete dilatation of the cervix uteri to
about 10 cm.
2nd Stage - From the complete dilatation of the cervix to delivery of the fetus.
3rd Stage - From the delivery of the fetus to expulsion of the placenta.
pain without interfering with the uterine kinetics which are necessary for the
7
TABLE-1 - Pain in Labour: Pathways and Mechanism (Crawford)12
L1 referred to
cutaneous branches
of posterior divisions
8
Pain pathways and mechanisms13,14
obstetric analgesia.
Intrinsic mechanism: During the first stage of labour, the pain is caused by:
1. Pressure on the nerve ending between the muscle fibres of the uterine
cervix and stretching of the lower uterine segment is occurring. The pain
experienced by the mother is very variable and bears no constant relation with
inferior, middle and superior hypogastric plexus and the lumbar sympathetic
chain. The white rami of spinal nerves T 11 and T12 are involved, but as labour
9
Pain pathways in second stage:
Intrinsic mechanism: Pain in the second stage of labour is mainly due to the
3. Stretching and tension of ligaments and muscle of the pelvic cavity and
itself as pain felt low in the back or in the thighs. Pain produced by stretching
posterior cutaneous nerve of thigh (S2,3), the genitofemoral nerve (L1,2) and
The Aδ and C fibres conduct pain sensations from the uterus and the
spinal cord. The pain of parturition is mainly a visceral pain and therefore is
conducted in the Aδ and C fibres to the spinal cord. These fibres make
10
contact with lamina I, II and V. The convergence of cutaneous and visceral
From the spinal cord, the pain signals are transmitted to the brain via
the spinothalamic tract, which is divided into lateral and medical system. The
lateral system projects into the somatosensory cortex and brings about higher
course of action. The medial system (slow conducting) project to the reticular
system and is responsible for primitive responses to pain, which includes the
During the latent phase of the first stage, the pain is felt as an ache or
a moderate cramp and is limited to the T11 and T12 dermatomes. As labour
progresses to the active phase, where the uterine contractions become more
intense, the pain in T11 and T12 dermatomes becomes sharp and cramping
The distribution of T10, T11, T12 and L1 dermatomes in the back overlies
the lower three lumbar vertebrae and the upper half of the sacrum. An
epidural block limited to these four segments produces relief of the low back
pain.
In the late 1st stage and in the early 2nd stage the pain is felt most
sharply in the perineum, in the lower part of the sacrum, anus and in the
Previously it was believed that the motor activity of the uterus was
segments and that uterine activity would be impaired by blockade upto the
fifth thoracic segment. However subsequent work showed that the uterus is
muscles, combined with tone of the pelvic diaphragm through which the
descending part of the fetus rotates. Premature loss of tone in the extrauterine
muscles will modify or delay the progress through poor expulsive efforts or
failure to rotate.
reflex come from receptors of the cervix and the vagina and pass centrally to
stimulate oxytocin secretion from posterior pituitary. However this deficit can
irregular contractions of a high basal tone develop into low pressure, regular,
release due to abolition of the Ferguson reflex. However indirectly, the neural
13
Physiological effects of pain13
segmental effects.
Cortical:
Pain will lead to fear, anxiety and increased skeletal muscle activity.
Suprasegmental:
increased lactic acid and free fatty acid production, hyperglycemia, increased
Segmental:
14
LABOUR ANALGESIA
15
Attempts to minimize the pain of labour non-pharmacologically first
began in the early 20th century. Natural childbirth was pioneered by Grantly,
Dick, Read in 1932. He suggested that the pain of childbirth was brought
mother about the functioning of her body and the physiology of labour. It
another labour companion, touch and massage, the application of hot or cold
application of a variable electrical stimulus to the skin at the site of pain and is
based upon the gate theory of pain control36. Studies have shown there to be
16
Systemic drugs13:
All drugs given systemically will cross the placenta to some extent.
Drugs which may reach the fetus in large amount are those with higher lipid
in first stage of labour and in 47.7% it gave no relief at all. Nausea and
vomiting occur in 50% of patients and exerts both immediate and long term
effects on fetus.
action compared to pethidine. It benefits from the ability to allay anxiety but
respiration.
active metabolite, desmethyldiazepam which has a very long half life. Fetal
17
it is with pethidine. The chief drawback of pentazocine is unpleasant
hallucinogenic side effects and the limited pain relief that it can produce.
adverse effect on uterine blood flow, uterine activity or neonatal status 23,24.
rapidly metabolised in the mother and fetus. It has been used in PCA(patient
out interval of 2-3 minutes. The side effects associated are sedation,
respiratory depression and other opioid related effects. Remifentanil PCA for
Inhalational agents:
Until 1983 when the central midwives board withdrew approval for the
inorganic fluoride concentrations are increased in both mother and infant, the
18
risk of renal damage seems negligible as long as inhalation is restricted to low
in 1881. It became widely used with the introduction of the Minnitl apparatus
(1934) which delivered a mixture of nitrous oxide in air. In the early 1960’s the
This has been stated by Beazley et al (1967) as 23% total success but 40%
analgesia but with a higher degree of drowsiness. More recently it has been
and offset of action, appears to be a best suited inhalational agent for labour
useful pain relief during the first stage of labour, and to a greater extent than
19
Figure- 3 - Pathways of labour pain illustrating the nerve pathways
responsible for pain in various stages of labour and the types of blocks that
can block nerve impulse transmission through these pathways to alleviate
labour pain
(Copied from Regional Anaesthesia and Analgesia for Labour and delivery; N
Engl J Med 2003;348: pg 320)
Floberg 1983). However in the first few minutes after initiating a block a high
have been seen (Baxi et al 1979). It has been suggested that the block should
reinvestigation.
pudendal nerve block was not totally effective in nearly 50% of cases.
obstetrics. Epidural analgesia provides the most effective form of pain relief
Corning has been credited with being the first to use epidural analgesia
in 1885. For many years caudal rather than lumbar epidural blockade was the
Tuohy’s needle in 1949 and the use of continuous catheter technique in both
blockade and its advantages with minimal local anesthetic dosage, thus
21
Caudal extradural block
Caudal extradural block is useful in the late first stage and second
Intrathecal block
Single shot spinal have limited utility in early labour and are more
incidence is low with the use of fine pencil point (26 or 27G) needles.
Since the introduction of this technique in the early 1980’s it has gained
increasing popularity for analgesia in labour and delivery. Because CSE has
a higher ambulatory potential it has been called the walking epidural. The
advantages are rapid and excellent pain relief, lower drug usage, and can be
1) Safety
system.
22
4) No depressant effects on the progress of labour.
23
ASSESSEMENT OF ACUTE PAIN16
Pain is a uniquely personal symptom with no reliable objective signs,
systems are used for adults; they correlate well and are generally reliable. It is
important that patients understand the method used, what us being assessed,
and why, and that the same method continues to be used to ensure reliability
applicable verbal method that can employ different descriptors of pain, e.g. No
Employs a 10-cm draw line with the left anchor point descriptor labeled
“no pain’’ and the right-sided equivalent labeled “worst possible pain”. It
requires patients to mark their current pain severity on the continuum. The
VAS score is the measured distance from the “no pain” point to the pain
estimate.
pain and “10”being the worst possible pain. VNRS is easy to use, has better
patients. Hence in this study we decided to use VNRS as the pain scoring
system.
24
Labour Epidural Analgesia
effective method of pain relief during childbirth, and the only method that
conclusion. Though CSEA is growing by leaps and bounds and offers effective
25
ANATOMY OF EPIDURAL SPACE
Definition13
spinal canal outside the dural sac. It extends from foramen magnum to
intervertebral formina.
Boundaries35
The epidural space contains nerve roots that traverse it from foramina
to peripheral location, fat, areolar tissue, lymphatics and blood vessels, which
26
Epidural Veins
Batson venous plexus37. The veins form a network that run in four main trunks
along the space. They communicate with venous rings at each vertebral level,
with the basivertebral veins on the posterior aspect of each vertebral body
and with the ascending and deep cervical, intercostals, iliolumbar and lateral
sacral veins. They connect the pelvic veins below with the intracranial veins
above, so that air or other local anaesthetic solution injected into one of them
large intra abdominal tumour) can distend the epidural venous plexus, with
Arterial Supply
supply adjacent vertebra, ligaments and spinal cord. These arteries are from
the vertebral, deep cervical, ascending cervical, intercostal and lumbar and
iliolumbar arteries. They anastamose with their neighbors above and below,
cross the midline and lie chiefly in the lateral parts of the epidural space.
The epidural space is always said to contain fat, but since dural sac
virtually fills the bony spinal canal, this usually amounts to no more than a thin
27
Nerve Roots13
31 pairs of spinal nerves with their dural cuffs traverse the space on
the skin. The distance from the postero-medial border of ligamentum flavum
should enter the space as close to the midline as possible to maximize the
make the ligamentum flavum feel softer39. Pregnant patients do not flex their
lumbar spine optimally, which may narrow the interspinous spaces and move
tilt of the spine in the lateral position potentially affecting the spread of
Epidural Volume13,36
The epidural veins are veins of the vertebral venous plexus, which form
an alternative pathway by which blood can reach the heart from the lower
obstruction to the inferior vena cava. In consequence, the epidural veins are
28
dilated and engorged. Since the total volume of the epidural space is fixed,
the engorged veins act as a space – occupying lesion to reduce the volume of
the extravascular portion of the space. Hence the local anaesthetic solution
injected in the epidural space will spread more extensively, reducing the dose
Epidural Pressure13
lateral position averages 1.63 cm H2O and rises to between 4-10 cm H2O by
the end of the first stage. Assuming the supine position will increase epidural
space pressure by upto 50% and this is proportional to the degree of inferior
Clinical Significance
methods of identifying the space that depend on negative pressure should not
be used.
and the sudden efflux of blood from the contraction myometrium into the
8cm H2O, even in lateral position. Adequate epidural pain relief minimizes the
29
Reasons for decrease in local anesthetic doses are:
2. Increased lordosis
3. Progesterone effect
drugs.42,43
Site of Action13
2. On the nerves in the paravertebral spaces after they have shed their
dural sheaths
30
Figure-4
Technique of Labour
Epidural Analgesia
(Copied from Regional
Anaesthesia and
Analgesia for Labour
and delivery; N Engl J
Med 2003;348:pg 320)
However, pregnancy does not enhance isolated spinal nerve root axon
31
INDICATIONS AND CONTRAINDICATIONS FOR EPIDURAL ANALGESIA
Indications16:
Maternal Fetal
Contraindications16
Absolute Relative
32
ADVERSE MATERNAL AND FETAL EFFECTS OF EPIDURAL
ANALGESIA13
Maternal
Immediate
Table-5 – Immediate complications of epidural analgesia
Subarachnoid
Due to Injection Intravascular
Adverse reaction to local anesthetic
Hypotension
Motor block
Neural blockade Bladder dysfunction
Horners syndrome
Shivering
Total failure
Inadequate analgesia
Partial failure
Prolonged labour
Progress of labour
Increased instrumental deliveries
Delayed
Epidural Hematoma
Chemical meningitis
Ischemia of cords
33
b) Headache - Post dural puncture
Fetal
Immediate
Delayed
a) Neurobehavioral Changes
Hypotension:
preloading the patient with ringer lactate solution (10-15ml/kg) and avoiding
puncture headache. Its incidence in obstetrics remains about 1-5% even with
34
very small-bore spinal needle and optimized tip. PDPH has a major impact on
Camann et al51 evaluated the use of caffeine for the treatment of PDPH and
the gold, standard treatment for PDPH with success rate of greater than 90%
by a cautious approach and using test dose before the injection of the drug.
Since a smaller dose is used in selective epidural block, recovery will be more
rapid.
Blood tap:
the catheter in an adjacent space in the event of bloody tap can prevent
15-45%. However similar rates of 10.5 – 40% have been reported following
vaginal delivery without epidural block (Grovel L.H, Moir D.D, Mc Arthur) and
study has found that back pain following epidural anaesthesia is common but
persistent back pain is much less common and a previous history of backache
anaesthesia.
Shivering:
Urinary retention:
When the epidural block affects the sacral segments the mother may
not be aware of full bladder which may impede the progress of labour. Thus
36
commonest was single nerve neuropathy. In most cases the problem resolved
avoid both the stress of painful labour and the risk of general anaesthesia
Pain relief:
only provides physiological benefits to both mother and fetus but also makes
Hypertension:
flow55. Early work also showed how the complete analgesia could minimize
37
can be little doubt however of its value in preeclampsia provided the catheter
Cardiac disease:
labour. Epidural pain relief can minimize the adverse effect of increased
Pulmonary disease:
Trial of labour:
from the scar and pain from the uterine contractions are felt at the same site
and the scar is most likely to be stressed during a contraction. Epidural local
Rowbottom56 in his study found that the pain of uterine rupture was relieved
by bupivacaine 0.375% 6ml but not masked by the addition of fentanyl 25mcg
to bupivacaine 0.25% 6ml. The same phenomenon has been observed with
placental abruption in which epidural blockade does not abolish the pain
(Paterson 1979). Analgesia given early in these patients may reduce maternal
38
exhaustion and subsequently be converted to epidural anaesthesia in case a
simply altering the dose of the drug, and the position of the patient, thus,
labour did improve the outcome for baby. Labour is less stressful and delivery
mortality rate among low birth weight babies (David and Roren 1976).
Likewise the outlook in twin pregnancy particularly for the second twin is
pain, epidural block can improve uterine contractility and rhythmicity and is
Fetal indications:
39
Decreased blood loss:
compared to delivery without epidural block (Bound A.G., Minor D.D). This
to venous pooling and thus decreased cardiac output. Also, since the pelvic
Modes of epidural:
anaesthetic or local anaesthetic with opioids. Following this there are different
their pain increases. The maternal satisfaction is good & quality of analgesia
is good. But there may be peaks and valleys in pain relief. There is greater
local anaesthetic and opioids and breakthrough pain is treated with top-up
is also continuous without the peaks and troughs. The amount of drug
40
3.PCEA(patient controlled epidural analgesia) – Here the patient
controls her own medications. The PCEA can be given as demand only or
with continuous infusion The bolus, lock-out interval, maximum dose per hour
are set with or without a basal infusion. The maternal satisfaction is the
highest in this group, since it gives the pain control in the hands of patient
itself. The quality of analgesia is good, the drug utilization minimal. The risk of
only PCEA has an increased incidence of breakthrough pain and higher pain
scores.
41
ROPIVACAINE
It is a new, long-acting local amide anesthetic with similarities in
STRUCTURAL FORMULA
sodium and raises the threshold for electrical excitability. It blocks the
the threshold for electrical excitation in the nerve, by slowing the propagation
of the nerve impulse, and by reducing the rate of rise of the action potential.
The order of blockade affecting the nerve fibres is: autonomic, sensory and
motor; and the effect disappears in the reverse order. Clinically the order of
42
PHYSIOCHEMICAL PROPERTIES
PHARMACOKINETICS 58
ABSORPTION
administration site. From the epidural space, ropivacaine shows complete and
minutes and 4.2 ± 0.9 h, respectively. The slow absorption is the rate limiting
factor in the elimination of ropivacaine which explains why the terminal half-
DISTRIBUTION
43
acid glycoprotein. An increase in total plasma concentrations during
METABOLISM
Urinary excretion of the 4-hydroxy ropivacaine, and both the 3-hydroxy N-de-
ropivacaine are the major metabolites excreted in the urine during epidural
infusion. Total PPX concentration in the plasma was about half as that of total
44
have a pharmacological activity in animal models less than that of
ropivacaine.
ELIMINATION
The kidney is the main excretory organ for most local anesthetic
metabolites. In total, 86% of the ropivacaine dose is excreted in the urine after
mL/min.
PHARMACODYNAMICS
output and arterial blood pressure. Animal studies have demonstrated that the
effect on the medulla and on higher centers. The depressed stage may occur
smallest dose and concentration required to produce the desired result should
be administered.
individual tolerance, and the physical condition of the patient. Patients in poor
46
or complete heart conduction block, advanced liver disease or severe renal
condition before major blocks are performed, and the dosage should be
adjusted accordingly.
Figure-6 - Dosage
recommendations for
ropivacaine in adults and
children
47
SIDE EFFECTS:
INCIDENCE (≥5%)
INCIDENCE (1-5%)
tract infection.
PRECAUTIONS:
48
BUPIVACAINE
following structure
MECHANISM OF ACTION
sodium and raises the threshold for electrical excitability.60 It blocks the
the threshold for electrical excitation in the nerve, by slowing the propagation
of the nerve impulse, and by reducing the rate of rise of the action potential.
these channels and preventing their change to rested closed and activated
49
open states in response to nerve stimulus. It binds to specific sites located on
the inner position of the sodium channels and obstructs the external openings
and maintains them in the inactivated closed state, which is not permeable to
sodium, so that the conduction of nerve impulses does not occur. On repeated
block. The sole use of local anesthetic is less common than the use of local
Clinically, the order of loss of nerve function is as follows: (1) pain, (2)
temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
PHYSIOCHEMICAL PROPERTIES
50
The dural permeability and the movement of local anaesthetic through
speeding the onset of action and also increasing the potency and duration of
effect. Higher the aqueous lipid solubility coefficient (343 for bupivacaine),
more rapid is the entry into the lipid membrane and longer is the duration of
action.
PHARMACOKINETICS
ABSORPTION
51
moderately larger total doses and sometimes prolonging the duration of
action.
than with any other commonly used local anesthetic. It has also been noted
that there is a period of analgesia that persists after the return of sensation,
DISTRIBUTION
Generally, the lower the plasma concentration of drug, the higher the
cross the placenta by passive diffusion. The rate and degree of diffusion is
governed by: (1) the degree of plasma protein binding, (2) the degree of
ionization, and (3) the degree of lipid solubility. Fetal/maternal ratios of local
binding, because only the free, unbound drug is available for placental
transfer. Bupivacaine, with a high protein binding capacity (95%), has a low
dependent.62
ionization and lipid solubility of the drug. Lipid soluble, non-ionized drugs
52
Depending upon the route of administration, local anesthetics are
distributed to some extent to all body tissues, with high concentrations found
in highly perfused organs such as the liver, lungs, heart and brain.
throughout the highly perfused organs such as the brain, myocardium, lungs,
drug with poorly perfused tissues, such as muscle and fat. The elimination of
drug from tissue depends largely upon the ability of binding sites in the
hours.
epinephrine, factors affecting urinary pH, renal blood flow, the route of drug
analgesia and maximal motor blockade more rapidly than younger patients.
53
administration of this product. The total plasma clearance was decreased in
these patients.
METABOLISM
primarily in the liver via conjugation with glucuronic acid. Patients with hepatic
EXCRETION
The kidney is the main excretory organ for most local anesthetics
elimination half-life is 210 minutes. In infants and elderly the half life is
prolonged.
bupivacaine does not ordinarily produce irritation or tissue damage and does
PHARMACODYNAMICS
depressant effect on the medulla and on higher centers. The depressed stage
smallest dose and concentration required to produce the desired result should
be administered.
55
factors such as partial or complete heart conduction block, advanced liver
the patient's condition before major blocks are performed, and the dosage
sensory block, but the effect on motor function differs among the three
concentrations.
relaxation is used concurrently. Onset of action may be slower than with the
56
Maximum dosage limit must be individualized in each case after
evaluating the size and physical status of the patient, as well as the usual rate
and 175 mg without epinephrine; more or less drug may be used depending
studies to date, total daily doses up to 400 mg have been reported. Until
epinephrine.
patients.
epinephrine if not contraindicated. Use only the single dose ampoules and
57
single dose vials for caudal or epidural Anaesthesia; the multiple dose vials
contain a preservative and therefore should not be used for these procedures
is proportional to the time the drug is in contact with the nerve fibres. The
epinephrine is less than that observed with lidocaine which is attributed to its
SITE OF INJECTION: Rapid onset and shorter duration occur with intrathecal
increases the amount of drug in the unionized for resulting in faster onset of
conduction blockade. Carbon dioxide raises the threshold for impulse firing by
solutions.64
58
SIDE EFFECTS
1. Allergic reactions
2. Systemic toxicity
SYSTEMIC TOXICITY:
block.67 It is found that due to rapid saturation of the protein binding sites,
significant mass of unbound drug is available for diffusion into the conducting
10mcg/ml.68
59
The threshold for cardiac toxicity produced by bupivacaine may be
receptor site is slow causing persistent depressant effect on Vmax and cardio
reverse.
depression and increase the threshold for ventricular tachycardia but since
the world's natural supply of bretylium is nearly exhausted, and the drug is no
longer available it has been deleted from the Advanced Cardiovascular Life
local anaesthetic over dosage. Human cases have been reported with
60
NEUROTOXICITY
USES
RECENT ADVANCES
effect occurs at much lower concentration than those required for sodium
protein signaling.77
CONTRAINDICATIONS
inflammation and or sepsis near the proposed site of injection, severe shock,
61
FENTANYL
STRUCTURAL FORMULA
Figure-8-Structure of Fentanyl
MECHANISM OF ACTION
brainstem and spinal cord) and outside the central nervous system in
peripheral tissues.79,80
the drug across the dura to gain access to mu opioid receptors in the
62
Figure – 9 – Epidural Opioids
When a drug is administered epidurally, it can reach the spinal cord by
diffusion through the meninges. The most important barrier to meningeal
permeability is the arachnoid mater; meningeal permeability is determined
primarily by the drug’s lipid solubility. In the spinal cord, equilibrium of the
nonionized hydrophilic drug (blue circles) and the ionized hydrophilic drug
(red triangles) at the site of the spinal opioid receptor (purple receptors) is
shown, as well as nonspecific lipid-binding sites (green receptors).
Diffusion into the epidural space and into epidural veins is the major route
of clearance, as illustrated in the left portion of the image.
Copied from Eltzschig HK, Lieberman ES, Camann WR. Regional
anesthesia and analgesia for labor and delivery. N Engl J Med. 2003 Jan
23;348(4):319-32.
PHYSIOCHEMICAL PROPERTIES
63
PHARMACOKINETICS
sites such as fat and skeletal muscles.83 The lungs exert a significant first
pass effect and transiently take up approximately 75% of the injected dose.84
The t1/2 α is 1-2.5 minutes and t1/2 β is 10-30 minutes. The volume of
kidneys and can be detected in urine upto 48 hours. Animal studies suggest
that nor-fentanyl has less analgesic potency than fentanyl.85 The elimination
half-life is 3.1-6.6 hours. The elimination half time is longer than morphine due
to greater lipid solubility and larger volume of distribution. The clearance rate
is 1530 ml / minute. Context sensitive half time after 4 hours of infusion is 260
minutes.
PHARMACODYNAMICS
produces ceiling effect with increased dosage hence little effect on EEG. It
also decreases CMRO2 and intracranial pressure, increases muscle tone and
central vagal nucleus and reduction of sympathetic tone thus decreasing the
64
to tracheal intubation and causes dose dependent depression of ventilatory
response to CO2.
sphincter and delays gastric emptying. It increases biliary duct pressure and
which provides the best pain relief with minimal side effects. The addition of
epidural space.88
65
REVIEW OF LITERATURE:
ropivacaine 0.25% with bupivacaine 0.25% on pain relief and motor block
an epidural infusion of the same drug at 6-12 ml/h. Top-up boluses of 6-10ml
were given as and when required. They found that the onset of pain relief
statistically different between the groups. However the ropivacaine group had
score(NACS) >35 than the bupivacaine group 2 hours after delivery. They
bupivacaine 10 ml was given (the same drug as the main dose). The study
ended when a second top-up was requested or delivery of the baby occurred.
The only significant difference between the groups was a shorter onset of pain
relief after the main dose of bupivacaine. There were no significant differences
66
sensory block and motor block between the groups. Cardiovascular changes
analgesia (median 3.0 vs 2.0) (P < 0.05). The onset of sensory block, quality
satisfaction were similar in both groups. The incidence, intensity and duration
of motor block were slightly but not significantly less in the ropivacaine group.
4/6/8/10 ml/h and additional bolus doses as and when necessary. Contraction
pain, quality of analgesia, sensory block, motor block and neonatal Apgar
the 4 ml/h group required more boluses and the 10ml/h group received a
continuous extradural infusion at 6-8 ml/h and may be used as the sole
was provided with 5-mL "top-up" injections as and when necessary. Pain relief
was assessed by using a visual analog pain scale (VAPS) and motor block
was assessed by using a modified Bromage scale. They found that all
infusion regimens effectively decreased VAPS, and most patients in all groups
had minimal or no motor block at the end of the first stage of labor. Mean total
number of the top-up injections required per patient were 3, 2, 1.5, and 1.4,
respectively, in the 4, 6, 8, and 10-mL/hour groups (P < .05, 4 mL/hour vs. all
other groups). Despite receiving more total bolus dosages, the 4-mL/hour
group had less motor block in the lower extremities (P < .05). Apgar scores
and neurological adaptive capacity scores were similar for all groups.Thay
finally concluded that a rate of 6 mL/hour may be the lowest effective rate that
provides the best combination of pain relief, motor block, and rebolusing.
5 ml, available every 10 min with a 30-ml/h limit. For inadequate analgesia,
68
10-ml boluses of study solution was administered until patient comfort was
pain relief for the initiation of labor epidural analgesia. Group I received 0.2%
ropivacaine. Initially 13 ml was given in each group. Fifteen minutes later, the
adequacy of analgesia was assessed. If the patient reported that her degree
was given, the degree of pain relief was reassessed 15 min later and the
0.2% ropivacaine offers significant analgesia more often than 0.15% or 0.1%
The duration of analgesia, visual analogue scores for pain, motor blockade
nausea, pruritus, heart rate, and blood pressure were recorded. There were
reboluses, total infusion volume, VAS pain scores, duration of 2nd stage of
incidence of motor block after the 3rd injection. They concluded that 0.125%
blockade.
Fentanyl and 0.125% Bupivacaine with 2µg/ml Fentanyl for epidural Labour
used patient satisfaction or side effects between the groups. However the
whether these results are applicable to anesthesia practices which do not use
dilation received either 20ml of 0.08% Bupivacaine and 2µg/ml Fentanyl (BF)
analgesia. They found that 0.08% Ropivacaine and 2µg/ml Fentanyl provided
Plain Ropivacaine 0.2%, 15-20 ml was titrated until analgesia and bilateral
sensory block to T10 was produced (Time Zero).Patients were then given
boluses of 10ml of the same solution and on request additional 10ml were
given for analgesia. They found no differences between the two groups in
However the total drug dose used in the intermittent group was lower and
duration of uninterrupted analgesia (time to 1st rescue bolus) was longer. They
ropivacaine and 0.5 µg/ml sufentanil with that of 0.1% bupivacaine and 0.5
µg/ml sufentanil via patient controlled epidural analgesia route during labor. A
test dose of 5ml study solution was administered, followed by a loading dose
5 min later. PCEA regimen was of 5ml bolus,10 min lockout time.
71
Supplementary analgesia was of 5ml of study solution administered through
the PCEA pump by the nurse. The two groups did not differ in VAS, volume of
group had significantly less motor block during first stage of labor and the
second stage of labour was shorter. The ropivacaine group patients also
They concluded that 0.1% ropivacaine and 0.5 µg/ml sufentanil produce less
motor block but are clinically less potent than 0.1% bupivacaine and 0.5 µg/ml
fentanyl. The median VAS scores were not different between the groups at
ropivacaine group had no demonstrable motor block after the first hour
compared with only 55% of patients given bupivacaine. They concluded that
ropivacaine infusion was associated with less motor block throughout the first
Then one group was started on 0.125% ropivacaine and another group on
maximum volume per hour of 20 ml. Both groups were similar in the ratio of
used per hour was lower in the group that received fentanyl. They concluded
ropivacaine.
enantiomer) amide local anaesthetic with a high pKa and low lipid solubility
which blocks nerve fibres involved in pain transmission (A delta and C fibres)
to a greater degree than those controlling motor function (A beta fibres). The
but more so than lidocaine (lignocaine) in vitro and had a significantly higher
and 0.3 mg/L, respectively). Extensive clinical data have shown that epidural
bupivacaine with regard to pain relief but caused less motor blockade at low
compared ropivacaine 0.2% with bupivacaine 0.1% with fentanyl for analgesia
received 0.1% bupivacaine with fentanyl 2 µg/ml and 102 women received
10 ml. Breakthrough pain not responding to a routine top-up was treated with
patient VAS for first and second stage analgesia, overall satisfaction, and
received fewer routine top-ups and fewer escape top-ups. The ropivacaine
group was more likely to be pain free in the first stage. There were no
delivery between the groups. Pain relief and satisfaction scores from
midwives and patients were consistently better in the ropivacaine group, but
74
Merson N(2001)104 did a comparison of motor block between
sufentanil added to it. A continuous infusion of a 0.1% study drug infusion with
motor block in the low ropivacaine group. Though the pain relief seemed to be
less satisfactory in the ropivacaine groups, the difference was not statistically
bupivacaine in the 0.25% and the 0.125% loading doses, with the greatest
demands ratio (p < 0.05). They also found that both groups were clinically
indistinguishable in terms of pain relief and side effects. They concluded that,
75
at a concentration of 0.125%, ropivacaine and bupivacaine were equally
initiated with 8ml of 0.7% lignocaine and 50µg of fentanyl for both the groups.
0.1% ropivacaine with fentanyl 2 µg/ml was started at 15ml/h depending upon
the study group. Top-up boluses of 5ml of study solution was used as and
providing highly effective epidural analgesia for labor with minimal motor
block, but the results suggest that bupivacaine may be more potent than
ropivacaine.
the two groups for pain scores, total volume of anaesthetic solution used,
and equivalent analgesia during labour, with similar incidences of motor block.
76
Lacassie HJ et al.(2002)108 conducted a study to determine the motor
defined as a Bromage score <4 within 30 min. The up-down sequences were
analyzed by using the Dixon and Massey method and probit regression to
quantify the motor block minimal local analgesic concentration. They found
that motor block MLAC for bupivacaine was 0.326% and for ropivacaine was
0.497%. The ropivacaine/bupivacaine potency ratio was 0.66 and was similar
concentration near the reported 50% effective dose values for ropivacaine
routine clinical use in labor epidural. This was because studies had shown
with 20 ml of study dolution and PCEA was initiated with the following
settings: 6 mL/h basal rate, 5 mL bolus, 10 min lockout, and 30 mL/h limit.
Breakthrough pain was treated with 10-mL boluses of study solution. They
found that both 0.075% ropivacaine and bupivacaine, with fentanyl, were
with 0.2% ropivacaine and the patients were then randomized to receive one
= 19), 0.1% ropivacaine (group R1, n = 19), or 0.1% ropivacaine with 2 µg/mL
effective analgesia during early labor, with all groups requiring similar
Patient and midwife satisfaction and obstetric and neonatal outcomes were
the first stage of labor. The addition of 2 µg/mL fentanyl to 0.1% ropivacaine
bupivacaine 0.2% and ropivacaine 0.2% combined with fentanyl for the
ml of the study solution according to parturients' needs when their pain was >
satisfaction and side effects between groups were evaluated during labour
block was observed in 10 patients in the B/F group whereas only two patients
had motor block in the R/F group (P < 0.05). The incidence of instrumental
delivery was also higher in the B/F group than in the R/F group (P< 0.05).
provided effective analgesia with significantly less motor block and need for
ASA I-II women, each carrying a single fetus at full term and in spontaneous
mL/h of 0.125%. The bupivacaine group (B) (n = 30) received the same
Bromage scale and hemodynamic stability, fetal status, type of delivery and
the total dose of local anesthetic was also recorded. Analgesia and
R (p < 0.05). Fetal status was similar in both groups. Both drugs were equally
effective for controlling the pain accompanying labor, such that ropivacaine
motor block effect at the doses administered may offer an advantage in some
ropivacaine plus 0.5 µg/mL of sufentanil with that of 0.1% ropivacaine plus
0.5 µg/mL of sufentanil for labor analgesia. This was done to determine
controlled study on 130 parturients. They found that 0.1% Ropivacaine plus
labor analgesia was equally as effective as ropivacaine 0.15% plus 0.5 µg/mL
instrumental deliveries.
80
Gogarten W et al.(2004)114 did a multicentric double-blinded
initial bolus of 10 mL of the study solution, and once visual analogue scores
motor blockade. They concluded that despite recent studies indicating that
effects.
with fentanyl 2µg/ml in labour epidural analgesia. All patients had epidural
analgesia initiated with 0.2% ropivacaine and fentanyl and were then
found that there were no significant differences between the groups in visual
analogue pain scores, motor block or sensory block. Side effects, patient
groups. However the amount of local anaesthetic used was lower in the 0.1%
ropivacaine plus fentanyl group than in the 0.2% ropivacaine group. They
blinded study in 162 ASA-I and II full term primiparous laboring women to
ropivacaine 0.1%. Vital signs, VAS score, sensory and motor block were
with fentanyl 2 µg/mL. Analgesia was maintained with an infusion of the same
solution at 10 mL/h. The primary endpoint was the operative delivery rate
it was removed from the US market). There was less motor block in the
groups, P less than 0.05. There was no significant difference in the duration of
the first or second stage of labor, the total dose of LA received per hour of
or neonatal outcome.
defined as VAS score ≤30mm. The relative median potency for each local
10ml of 0.125% Bupivacaine. The patients were randomly divided into two
bupivacaine (5, 10, 15, 20, 30, or 40 mg) or ropivacaine (7, 15, 20, 30, 45, or
60 mg) in 20 ml of saline. Visual Analog Scale pain scores were recorded for
30 min. Response was defined by the percentage decrease in pain score from
(15.3 mg vs. 11.3 mg, P = 0.0003), but ED90 was similar (40.6 mg vs. 33.4 mg,
84
P = 0.29). The potency ratio at ED50 for ropivacaine:bupivacaine was 0.75.
The curves had similar steepness .They concluded that ropivacaine is less
ED90 doses.
0.08% ropivacaine and fentanyl 2 µg/ml on the mode of delivery and other
incidence of temporary maternal fever and the cost of local anesthetic were
was lower than for the ropivacaine group. 0.06 % levobupivacaine was as
effective as 0.08% ropivacaine,when both were used with fentanyl 2 µg/ml for
scientific committee approval was obtained. All patients admitted to the labour
the patient was collected. Routine investigations like blood grouping and
typing, hemoglobin and platelet count were done as per our hospital labour
protocol. Patients fulfilling the inclusion criteria and who gave consent were
Inclusion Criteria:
Exclusion Criteria:
2.Pre-term pregnancy
3.Multiple pregnancy
86
Materials needed:
1. 18 G Tuohy needle
2. 20 G epidural catheter
Oxygen cylinder.
87
Figure-10 - Epidural tray and epidural set
88
Methodology:
An 18G IV cannula was inserted and patient was started on an infusion
The patient was then positioned in Lt. lateral position or sitting position
based on the anaesthetist convenience and her back aligned with the edge of
the bed. Under strict aseptic precautions, the skin over the lower thoracic and
lumbar region was cleaned and area draped. The best interlumbar space
The skin was pierced with 18G needle in the interlumbar space. The
epidural needle was inserted with bevel facing upward and pushed till it
pierced the interspinous ligament. The stylet was then removed. A 10ml
LOR(Loss Of Resistance) syringe filled with either Air or saline was attached
to the hub of the epidural needle. The needle was then slowly advanced with
pressure exerted on the air/saline column through the plunger of the LOR
syringe. The epidural space was identified with LOR to injection of air or
saline. Careful aspiration was done to make sure that the duramater was not
punctured. If CSF was aspirated, the needle was withdrawn and reintroduced
in a different space. If no CSF was aspirated, the LOR syringe was removed.
The depth of the epidural space was noted. A 20G fine epidural catheter was
threaded through the needle into the epidural space. The epidural needle was
remained in the epidural space. Careful aspiration of the cathter was again
89
Once the cathter was satisfactorily sited, the puncture site was cleaned
and an occlusion dressing applied over it. A bacterial filter was attached to the
with Adrenaline) was injected via the catheter to rule out intravascular or
minutes the patient was turned supine. A bolus dose of the test drug was
given followed by the infusion. The bolus and infusion protocol of each study
every 15 minutes in the first hour, every 30 minutes in the second hour and
every hourly thereafter. Continuous fetal heart monitoring was also done.
90
Parameters monitored:
1.Pain relief
2.Motor block
3.Duration of labour
- Cesarean section
Sample size:
occurrence of motor block between the two groups. The optimal sample size
required would be 25 in each group( 50 in total) with 80% power and 5% level
91
Statistical analysis:
for social sciences) version 17 for windows. The profile of the cases were
compared with the treatment allocation in order to check if there was any
Component bar and line diagrams were drawn as and when required. Chi-
92
Results and Observation
patient ASA grade, patient gravid and parity, vaginal dilatation, site od epidural
Age :
The patients age ranged from 17-36 years. The average age did not
differ between the two groups. The mean age of women in Group-A was
Weight :
The patients weight ranged from 46-89 kgs at the time of presentation.
The average weight of the women allocated to group-A was 68±8.86 kgs and
93
Figure-11- Age and Weight by group
68
64.29
25.37 25.23
Age(Years) Weight(Kgs)
Group-A Group-B
10 8 10
4.4
5 5
1 1
0 0
Gravida 1 Gravida 2 Gravida 3 Parity 0 Parity 1
94
ASA grade:
pregnancy, the rest 5(7.1%) had ASA grade II pregnancy. The distribution of
94.3
91.4
100
80
% of women
60
40
20 5.7 ASA-I
8.6
0
ASA-II
Group-A
Group-B
Figure-14-ASA grade by group
Comorbid conditions:
Group-A and Group-B each had one women(2.9% in each group) with
Vaginal dilatation:
The average vaginal dilatation of the whole group was 3.44±0.65 cm.
3.51±0.74 cm. This variable did not have any statistically significant
difference.(p=0.206)
95
Level of epidural placement:
More than 50% of the patients in both the groups received epidural in
among both the groups did not have any statistical significance.(p=0.287)
100
90
80 68.6
70
51.4
% of woen
60
Group-A
50 40
Group-B
40
30 22.9
20 8.6 8.6
10
0
L2-L3 L3-L4 L4-L5
Outcome measured:
Hemodynamics:
The minimum monitoring time was around 3 hrs in both the groups. The
following table will show the number of patients monitored over the time
96
PATIENT DISTRIBUTION:
The following table shows the heart rate variations in both groups.
97
COMPARISON OF SYSTOLIC BLOOD PRESSURE:
98
COMPARISON OF RESPIRATORY RATE:
patients among both groups including heart rate, systolic blood pressure,
Pain relief:
bolus. The pain levels did not go above VNRS (verbal numerical rating scale)
of 3 during infusion in both the groups. Most of the increase in pain scores
occurred during the second stage of labour. But the pain score variation did
Bolus requirement:
100
Mode of delivery:
60
Vaginal assisted
50
40 Vaginal spontaneous
62.9
30 54.3
20
10
0
Group-A Group-B
Duration of labour:
The following chart shows the average duration of 1 st,2nd and 3rd stage
101
Neonatal outcome:
The neonatal outcome was rated with Apgar acore at 1 & 5 minutes.
The average Apgar score during 1st minute assessment was 7.65±0.59 and
minutes(0.221).
9
10 7.68
8.94
Mean APGAR score
7.65
8
6
Group-A
4 Group-B
2 Group-B
0
Group-A
Minute 1
Minute 5
NICU admission:
(p-0.845). The indications for admission in NICU in group-A were cord around
102
Motor block:
belonging to group-B. This was observed during the 5th hour in all 3 patients.
Numbness:
group-A. It was seen in 6th and 7th hour. The numbness rate was not
statistically significant.
Pruritis:
103
Discussion
pain relief, a reduction in the need for additional pain relief , a reduced risk of
ropivacaine). There have also been many studies which state to have
bupivacaine vs 0.15% ropivacaine). Most of the studies have found that both
drugs did not differ significantly except ropivacaine had less motor block on
prolonged infusion.
15ml/hour.16
104
We used 6ml of 0.2% ropivacaine for initiation(Beillin1999)94 and 6ml/hr
for maintenance.
bupivacaine with fentanyl to see whether a less potent ropivacaine offers the
same pain relief and if it offers any significant advantage over bupivacaine at
this concentration.
Pain relief:
are many different scales to measure pain - verbal rating scale, numerical
rating scale (NRS), visual analog scale(VAS) etc. In our study we used NRS
as the pain scoring system because it was easy to use along with patients’
In our study we found that the mean pain level was 7.8±0.7 in
down to 0.31 in ropivacaine and 0.17 in bupivacaine group. The pain score
went upto 0.42 in ropivcaine and 0.52 in bupivacaine group at the end of 5
105
hours. There was no clinically demonstrable difference in the onset of pain
relief. This was consistent with the results obtained by Meister et al 200096.
ropivacaine along with fentanyl in both groups. They found that mean NRS
came down to 0.4 & 0.3 post epidural. This study finding was echoed in the
Motor blockade:
have minimal motor block and 5 of those studies were statistically significant.
block in the ropivacaine group. This difference was not clinically significant.
The incidence of motor block in our study was low in ropivacaine and
This may be because the volume of drug used in our study was low(6 ml
106
bolus and 6-8ml/hr infusion) thereby resulting in a lesser concentration of
drugs.
Duration of labour:
contraction, the dilatation of cervix and the descent of the presenting part of
fetus.
epidural and non-epidural methods of labour analgesia did not find any
ropivacaine. They did not find any difference in the duration of 1st stage of
Boselli 2003).106,109,113
The results of our study correlate well with the above mentioned
studies.
107
In contrast Lee et al 2002110 in their study compared found that the
bupivacaine group had longer first stage of labour than ropivacaine group.
significance.
prolonged when the duration was more than 3 hours for primipara and more
women who had epidural were more likely to have a longer second stage of
labour.
labour in both groups. The mean duration was 33.5 min in ropivacaine group
and 31.1 min in bupivacaine group. This difference was not statistically
significant. Our result coincides well with the meta-analysis done by Halpern
108
Mode of delivery:
vaginal delivery.
ropivacaine group and 37.1% in bupivacaine group which was not statistically
delivery. Our study results coincide with the study done by Finegold et al in
2000100, which used a similar concentration of drugs as our study. They had a
bupivacaine. In both our studies though the instrumental delivery rates were
bupivacaine in 2003 by Halpern et al123 also did not find any difference in
and 0.25% bupivacaine done by Writer et al125 in 1998 found that there were
1988122 and the recent Cochrane review 201134 done on epidural vs non-
and 8.6% in bupivacaine group. The main reasons for the cesarean delivery
among both groups were failure to progress, fetal distress due to cord around
cesarean delivery rates between ropivacaine and bupivacaine when used for
labor epidural.
observed that there was less fetal acidosis and less naloxone administration
In our study the fetal heart rate during the process of labour analgesia
was within normal limits. There was no incidence of post epidural fetal
bradycardia. The mean APGAR score was 7.65 & 7.68 in ropivacaine and
110
bupivacaine groups respectively. At 5 minutes it averaged to 8.94 & 9
groups.
Beilin and Halpern in 2010126 did a focused review with various studies
that compared bupivacaine and ropivacaine and concluded that there was no
capacity score, favoring ropivacaine, at 24 hours after birth, but not at 2 hours
after birth. But recent evidence suggests that the neurologic and adaptive
for both drugs.123 In addition, the umbilical artery and vein pH are well
110
maintained regardless of which local anesthetic is used. Also, the incidence
of need for neonatal resuscitation is low and similar with both drugs.117
111
Summary
analgesia.
any were recorded every 15 minutes in the 1 st hour, every 30 minutes in the
0.02 in both the groups till 2 hours. The mean score went upto 0.42 in
The number of patients who required bolus were 7(20%) in both the
groups.
112
to 3(8.4%) patients in Group-B. These differences were not statistically
significant.
The duration of first stage of labour was 467 minutes in both the
groups.
groups.
We did not measure the umbilical cord pH to know the effect of drugs
113
Conclusion
painless event. As a means toward this end, we should ideally adopt the best
minimal side effects and absolute safety to the mother and child.
The observations of this study show that pain relief offered by epidural
114
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Epidural infusion preparation:
Group-A
Group-B
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INSTRUCTIONS FOR LABOUR WARD STAFF
4. SpO2< 90%
line )
3. Motor Blockade
4. Patchy Block
5. Pruritis
6. Nausea / Vomitting
7. Urinary Retention
3. If hypotension:
1. Stop infusion
2. Rush fluids
3. IV ephedrine 6mg
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