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Alexandria Journal of Anaesthesia and Intensive Care
11
Plain Versus Hyperbaric Ropivacaine for
Spinal Anesthesia in Cirrhotic Patients
Undergoing Ano-rectal Surgery
Essam A. Eid MD*, Faisal AlSaif. FRCS, AB**
*Associate Prof.Anesthesiology, King Saud University, KSA
Assist. Prof. Anesthesiology, National Liver Institute, Menoufia University, Egypt
**Assist. Prof., Head of Hepatobiliary Unit, KKUH, Riyadh, KSA
Background: In cirrhotic patients undergoing ano-rectal surgery, spinal anesthesia/analgesia
remains a challenge. Coagulopathy and intraoperative hypotension represent a major challenge
for the anesthetist during spinal anesthesia in those patients. This study was designed to examine
the efficacy and the adverse effects of ropivacaine (plain, hyperbaric) spinal anesthesia for
anorectal surgery in cirrhotic.
Material and Methods: Forty known cirrhotic patients categorized as Child-A, scheduled for anorectal surgery under spinal anesthesia were enrolled in this study. Patients were randomly
allocated into 2 equal groups. Patients received 2.0 ml ropivacaine 0.6% (6 mg/ml), either in plain
solution (group I) or with glucose (hyperbaric) group II. 10µg fentanyl was added for each solution.
The extent and duration of sensory and motor block, pulse rate, blood pressure, and time to
mobilization were recorded. Any unwanted effects related to spinal blockade were also recorded.
Results: There were significant differences in median time to onset of sensory block at T10 (plain
9 min; hyperbaric 3 min; P<0.01), median maximum extent (plain T8; hyperbaric T6; P<0.05), and
median duration of sensory block at T10 (plain 66 min; hyperbaric 113 min; P<0.01). However,
median times to complete regression of both sensory (183 vs 156 min; P<0.05) and motor (158 vs
123 min; P<0.05) block were longer in the plain group. Patients mobilized sooner in the hyperbaric
group (plain 192 vs hyperbaric 131 min; P<0.01). All the hyperbaric blocks were adequate for
surgery, but three patients receiving plain ropivacaine required sedative/analgesic bolus during
anal dilatation.
Conclusion: The practice of spinal anesthesia in patients with mild cirrhosis is a safe and reliable
anesthetic technique. Addition of glucose 50 mg/ml to plain ropivacaine 6% increases the speed of
onset, block reliability, duration of useful block for ano-rectal surgery, and speed of recovery.
Moreover hemodynamic stability is a prominent feature of that block.
nal surgery in patients with
normal liver function and having
the criteria of American society
of anesthologist (ASA) class I and II,
represent
one
of
the
commonest
ambulatory procedures that carried out
every day in every hospital with
perioperative morbidity of 0.0-0.05 %(1).
However, "Child A" cirrhotic patients,
although they have normal coagulation
profiles, may develop serious alterations in
coagulation with deranged hepatic function
during the perioperative period(2). Moreover,
general anesthesia remains a challenge,
mainly because of the small range between
the therapeutic effect and side effects
(limited therapeutic index) of conventional
opioids, hypnotics and muscle relaxants
given intravenous (IV). Those patients have
altered multiple neurotransmitter systems,
such as gamma-aminobutyric acid (GABA
ergic), glutamatergic, and opioidergic, which
A
make
the
anesthetic
outcome
unpredictable(3). Experimental studies have
shown that opioidergic neurotransmission
(such as µ and δ-receptors) may be altered
in cirrhotic patients, selectively increasing
receptor affinity for opioids. The exogenous
or endogenous stimulation of these
receptors may lead to impaired mental
function(4). The use of the spinal/epidural
route has proven very effective in the
postoperative care of high-risk patients.
However, the possibility of a bloody tap from
needle or catheter placement or continuing
trauma due to the presence of an epidural
catheter has been widely described and
may occasionally result in spinal bleeding.
Although epidural hematoma is a rare
event, it is always recorded in relation to
deranged haemostatic capacity or complete
anticoagulation(5). While, Child-A cirrhotic
patients had a normal coagulation state,
there is lack of researches about spinal
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Alexandria Journal of Anaesthesia and Intensive Care
anesthesia in those patients and the
behavior of them during the stress of the
perioperative period.
Spinal anesthesia with short acting local
anesthetic i.e. lidocaine, was the most
useful choice for anorectal procedures in
the ambulatory surgery setting(1). However,
since 1993 when Schneider et al(6)
described severe radicular back pain, now
termed transient neurological symptoms
(TNS) after hyperbaric lidocaine spinal
anesthesia, its use in ambulatory surgery
have been reviewed. Preliminary work has
shown that ropivacaine provides spinal
anesthesia of shorter duration and less
motor blockade than bupivacaine, and may
be of particular interest in the day-case
setting(7). However, there are few data
comparing the actions of plain and
hyperbaric solutions of this drug.
Early studies of glucose-free (plain)
ropivacaine found that intrathecal injection
produced a sensory block of very variable
extent, and a large proportion of patients
required general anesthesia because of
inadequate distribution of block, mainly, but
not exclusively, in the patients receiving 10
mg and less(8). Since then, other studies
have shown that plain ropivacaine can
produce satisfactory analgesia for surgery,
but doubt remains about its reliability, as is
the case with other agents in plain
solution(7,8). Two recent studies of
hyperbaric ropivacaine (10 mg) have shown
that it produces predictable and reliable
anesthesia for surgery and with a duration
that is shorter than that of bupivacaine(9,10).
Saddle shaped spinal anesthesia has
been recommended as the ideal anesthetic
technique for ano-rectal surgery. Saddle
block found to be associated with minimal
intraoperative
hypotension,
fluid
requirements and rapid recovery and
discharge times(1). In the present study, lowlumbar approach for spinal block has been
used instead of saddle block, to allow
clinical comparison of plain ropivacaine
versus hyperbaric.
Fentanyl is increasingly being used as
adjuncts to local anesthetics. It enhances
spinal anesthesia without prolonging motor
recovery and discharge time. It is of less
lipid solubility compared to sufentanil, make
it of modest spinal selectivity ; gave
favorable analgesia in few minutes, for
12
modest duration (1-4 hours) and little risk of
respiratory depression(11). The addition of
fentanyl to plain and hyperbaric ropivacaine
increased equally the intraoperative quality
of spinal anesthesia in obstetric and nonobstetric patients(12). Intrathecal fentanyl is
sometimes accompanied by adverse effects
such as pruritus, nausea and occasionally
urine retention with delay of the discharge
of patients(13). The best risk-benefit dose of
intrathecal fentanyl ranged from 10 to 25
µg(11). This study was designed to examine
the efficacy and the adverse effects of 12
mg ropivacaine (plain, hyperbaric)-fentanyl
low lumbar spinal anesthesia for anorectal
surgery in cirrhotic.
METHODS
This randomized controlled, double
blind study was approved by the local
ethical hospital committee and informed
consent was obtained from each patient.
Forty patients who were ASA physical
status II-III, aged 18 yr or older, scheduled
for elective ano-rectal surgery were enrolled
in the study. All patients were known to
have liver
cirrhosis
of
Child-Pugh
classification grade –A. They were under
medical treatment (vitamin K, K+- sparing
diuretics, IV albumin, β-blockers (Inderal),
which continued in the perioperative period.
Exclusion criteria included patients of ChildPugh Score of grade B and C, those with
INR ratio > 1.5, patients who had chronic
analgesia therapy, scoliosis, and history of
previous back surgery, diabetes, or
peripheral neuropathies.
Patients received no premedication.
Upon arrival to the operating room, an IV
cannula
was
secured
under
local
anesthesia and IV NaCl 0.45% in Dextrose
5% solution was started (8.0 ml/kg/hr).
Every patient had automated blood
pressure, electrocardiogram, and pulse
oximetry
monitoring.
After
baseline
hemodynamic data were obtained, the
patient was positioned in the sitting position
for spinal blockade.
Patients were randomly allocated into
one of two equal groups according to a list
of random numbers: Group I (n = 20),
received 2.0 ml of 0.6% plain ropivacaine
(12 mg) and Group II (n = 20), 2.0 ml of
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Alexandria Journal of Anaesthesia and Intensive Care
0.6% hyperbaric ropivacaine (adding
dextrose 50 mg/ml plain ropivacaine).
Fentanyl 10 ug was added to each solution.
All solutions were provided in blinded vials
by the hospital pharmacy. Injections were
made with 25-gauge Quincke needle at the
L4-5 level over a period of 10-15 seconds,
and the time of which was defined as ‘zero’.
Patients immediately were put in 30º head
up position; their legs were wrapped with
elastic bandage and they were placed in the
lithotomy position. All patient received O2
via face mask (6 l/min).
The block was then evaluated by a
research nurse at 5 and 10 min after local
anesthetic injection. Sensory block was
evaluated with the short bevel end of a 27gauge dental needle: for caudal and
cephalad limits and duration of sensory
block (from onset of spinal anesthesia to
the regression to S2 level) were recorded.
Motor block was also assessed with a
modified Bromage scale(14) (mBS; 0, full
movement; 1, loss of hip flexor; 2, loss of
knee extension; 3, loss of planter
flexion/extension), and recorded the pulse
rate and mean blood pressure 2, 5, 10, 15,
20, 25, and 30 min after injection,
hypotension (more than 15% decrease in
mean blood pressure from baseline) was
treated with IV ephedrine 2-5 mg and 5%
albumin solution as required.
The patient’s ability to ambulate was
assessed
every
30
minutes
after
transportation of patients to the postanesthesia care unit (PACU) until
13
unsupported
ambulation
has
been
achieved.
Continued
non-invasive
monitoring of blood pressure, SpO2,
respiratory rate, electrocardiograph and
heart rate were recorded every 15 min in
the first hr and then hourly until the block
completely faded. Patients were kept in the
hospital for 48 hr for surgical re-evaluation
and recheck of his liver function. During this
period patients were hemodynamically
assessed every 3 hours and upon patient
request. Bladder catheterization was
performed when surgically indicated, but
time to micturition was recorded in all other
patients. Patients were telephoned 48 h and
7 days later to identify any sequlae.
Statistics: Data are presented as median
[range], mean (SD) or frequencies as
appropriate. Block characteristics were
compared using the two-tailed Mann–
Whitney U-test. A P value of <0.05 was
considered statistically significant. Data
were analyzed using a standard computer
based statistics package (Number Cruncher
Statistical Systems [version 2001], Cork,
Ireland).
RESULTS
Patients' demographic data, duration
and type of surgery were listed in (Table I).
The two groups were comparable with
respect to age, weight, height, male/female
ratio and duration of surgery.
Table I: Patient characteristics and duration of surgery
Group I (n=20)
(Plain ropivacaine)
13/7
41.6 ± 8.1
60.7 ± 11.8
173.4±6.4
0/16/4
Group II (n=20)
(Hyperbaric ropivacaine)
14/6
42.1 ±9.1
59.7 ± 11.1
171.9±7.1
0/16/4
Male/female
Age (yr)
Body weight (kg)
Height (cm)
ASA I/II/III
Child-Pugh Classification
A/B/C
20/0/0
20/0/0
Duration of surgery (min)
38.4±15.8
39.1±14.1
Type of surgery:
Hemorrhoidectomy
16
15
Sphincterotomy
3
3
Fistula repair
1
2
Data are presented as mean ± SD. No significant difference between groups
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No patient in group II required either
sedative/analgesics or induction of general
anesthesia. In group I, where plain
ropivacaine was used, three patient
required supplementation with sedative and
analgesics (2.0 mg midazolam/25 µg
fentanyl) to tolerate the anal dilatation
(Table II). Hyperbaric ropivacaine block
(group II) produced a significant rapid onset
(3 min vs 9 min in plain, P<0.01) and
complete regression of sensory block to S2
in significantly shorter duration (156 min vs
183 in plain P<0.05) compared to plain
ropivacaine group I. The onset of motor
block was slightly faster in the hyperbaric
group, but the maximum degree obtained
was the same in both groups. Median times
to complete regression of motor block were
significantly longer in the plain group (plain
158 min vs 123 min hyperbaric; P<0.05).
14
Patients mobilized sooner in the hyperbaric
group (131min vs 192 min in plain P<0.01).
No Transient Neurological Symptoms
(TNS) or post-spinal headache has been
reported in any patient of the two groups in
the first 48 hr after surgery. No patient
experienced respiratory hypotension or
bradycardia
during
the
intra
or
postoperative periods. Also, no patients in
the two groups suffered urine retention and
time to micturate was comparable. Three
patients suffered pruritus in group I, and
four patients in group II. However, pruritus
was very mild and no patient asked for
treatment (Table IV). There were no
significant differences in the incidence of
nausea and consumption of antiemetic
(Table IV). Lastly, liver function tests and
Child-Pugh classification showed no
significant changes in both groups
compared to the base-line values (Table V).
Table II: Characteristics of spinal anesthesia in each group
Sedative analgesics supplementation
Induction of general anesthesia
Onset of sensory block at T10 (min)
Highest level of sensory block (range)
Time to T10 sensory regression (min)
Time to S2 regression (min)
Time of onset of motor block (min)
Duration of motor block to Bromag 1 (min)
Time to ambulate (min)
Group-I (n=20)
3 (15%)*
0
9.12±3.9* (P<0.01)
T8 (T4-11)* P<0.05
113±23* P<0.01
183 ± 49* P<0.05
8.11±3.4
158 ± 28* P<0.05
192 ± 27* P<0.01
Group-II (n=20)
0
0
3.17±2.5
T6 (T4-10)
66±24
156 ± 32
7.71±3.3
123 ± 34
131 ± 28
Table IV: Incidence of post operative adverse effects
Nausea (%)
Pruritus (%)
Postdural puncture headache (48 hr) :
Incidence of TNS
Urine retention
Group-I (n=20)
2 (10%)
3 (15%)
0
0
0
Group-II (n=20)
2 (10%)
4 (20%)
0
0
0
Table V: Liver function tests and Child-Pugh classification in both groups
Liver function tests
Group-II (n=20)
Group-II (n=20)
preOp
postOp
preOp
postOp
Albumin (gm/dl)
3.9±0.6
3.8±0.7
3.9±0.6
3.9±0.7
PT (sec. prolonged)
2.9±1.3
3.0±1.2
3.0±1.1
3.0±1.2
ALT (IU, N=38)
68±14
71±15
69±16
69±15
GGT (U/L. N=11-50)
64±11
63±12
63±12
63±11
Child classification (n)
A (20)
A (20)
A (20)
A (20)
preOp (preoperatively), postOp (postoperatively), PT (Prothrombin Time), ALT (Alanine
Aminotranferase ), GGT (Gamma Glutamyl Transferase)
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DISCUSSION
Liver cirrhosis with portal hypertension,
coagulopathy,
altered
drug
pharmacokinetics and pharmacodynamics
and the accelerated hypercatabolic state
significantly altered the physiological
response of those patients during any kind
of stress whether surgical or non
surgical(15). Coagulopathy, hypotension and
pain are the triad of pathological events that
might complicate any surgical course in
those patients with an unexpected outcome
ranged from postoperative bleeding,
hematoma formation and infection up to
encephalopathy and coma(16). This study
was designed to examine the efficacy and
the adverse effects of either plain or
hyperbaric
ropivacaine-fentanyl
spinal
anesthesia for anorectal surgery in
cirrhotics.
The present study showed that a
hyperbaric solution of ropivacaine produces
a more consistent block than a plain one.
Addition of glucose led to a more rapid
spread to a higher median level and with
less variation in maximum sensory and
motor block. Moreover, complete regression
occurred sooner, allowing the patients to
mobilize earlier. This result documented
that increase the density of ropivacaine
produced by addition of glucose resulted in
a more even distribution of the local
anesthetic, and encouraging the spread of
the drug bolus ‘down’ the slopes of the
lumbar curve when the patient is placed
supine after injection due to the gravity
effect(17).
Usually, glucose-free solutions are
marginally hypobaric, and have been found
previously to be ‘unpredictable’, perhaps
because gravity does not encourage their
spread in the supine position. Spread is
likely to be more dependent on other factors
such as the currents produced by injection
and simple diffusion. This may mean that
more of the injected drug stays closer to the
point of injection, making the block less
useful
for
surgery, yet
prolonging
significantly sacral nerve block and so
delaying recovery(18). The last explanation
would answer the 15% failure rate in plain
ropivacaine group, were anesthesia was not
15
sufficient in three patients and necessitated
supplements of midazolam/fentanyl IV.
In two previous studies of Fettes and
Hocking(19,20), using 3 ml ropivacaine 5
mg/ml in either glucose 10 mg/ml or
glucose 50 mg/ml, produced a block that
was predictable, and adequate for lower
limb surgery in all patients. Similar findings
have also been obtained by others using
somewhat different protocols (e.g. larger
doses: 22.5 mg hyperbaric ropivacaine) for
spinal anesthesia for Caesarean section(21).
On the other hand, McNamee et al(9) used
smaller doses of drugs, they found that, 7.5
mg of 0.5% hyperbaric ropivacaine and 5
mg of 0.5% hyperbaric levobupivacaine
provide adequate spinal block for outpatient
knee arthroscopy, with a faster home
discharge as compared with 7.5 mg of 0.5%
hyperbaric levobupivacaine. Khaw et al(22)
compared 15 mg of either plain or
hyperbaric ropivacaine to 10 mg of
hyperbaric bupivacaine in cesarean section.
The
hyperbaric
ropivacaine
and
bupivacaine preparation produced a higher,
more consistent block with faster onset and
recovery in all case, whereas there was a
16% failure rate with the plain solution,
which is very close to our results. While
variability in spread can be minimized by
adding glucose, the variation in duration is
very much a patient-specific factor. The
average duration can be influenced by drug
and dose choices, but the variability
remains. This variability is even evident
between studies. In the previous study, the
median duration of 15 mg hyperbaric
ropivacaine (with glucose 50 mg/ml) at T10
was 56 min, whereas it was 66 min in the
present study although we used smaller
dose (12 mg hyperbaric ropivacaine). On
the contrary to our results, McDonald et
al(23), used sub-clinical doses of hyperbaric
ropivacaine in volunteers, concluded that it
was less potent than bupivacaine and
offered no advantage for use in outpatient
anesthesia. However, what they found was
that ropivacaine produced sensory block of
similar onset and extent as bupivacaine, but
that it was associated with less motor block
and faster regression of both sensory and
motor block, findings similar to those
reported here. However these results are of
great interest to liver patients as it gives a
reliable précised anesthetic course.
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In the present study, fentanyl in a
selected dose of 10µg has been added to
the anesthetic solution. Reuben et al(24)
reviewed the benefits of using lipophilic
opioids fentanyl as adjuncts to spinal
anesthesia. They concluded that, fentanyl
improved the quality of spinal anesthesia
without prolongation of motor block, allow
the anesthetist to use smaller doses of
spinal local anesthetic, yet still provide
excellent
anesthesia
for
surgical
procedures. Furthermore, fentanyl/local
anesthetic combination permits more rapid
motor recovery; short outpatient procedures
are therefore more amenable to spinal
anesthesia.
Side-effect
profiles
of
intrathecal lipophilic opioids are now well
characterized and appear less troublesome
than intrathecal morphine(25). Buckenmaier
et al(26) found that, the use of ultra-small
dose of ropivacaine 4.0 mg is similar to
lidocaine 25 mg in providing acceptable
surgical anesthesia for anorectal surgery in
an ambulatory setting. They also proved
that intrathecal fentanyl 25 µg provided
analgesia longer than either small-dose
local anesthetic could have achieved if used
alone without affecting the motor blockade,
Goel et al(27) compared different doses of
fentanyl added to bupivacaine for spinal
anesthesia in day case surgery reported
that, the addition of increasing doses of
intrathecal fentanyl (10, 20, 30, 40, and 50
µg) significantly improved the quality and
duration of analgesia without significant
increase in the incidence of severe
The
current
study
complications.
demonstrated that adding 10 µg intrathecal
fentanyl to ropivacaine (group I, II) induced
sufficient
anesthetic/analgesic
effects
without major side effects. Pilar Taurá et
al(28) used small dose ketamine (20/30 mg)
plus morphine (3.5-5 mg) through single
shot epidural analgesia in cirrhotic patients
Child-A class undergoing liver resection.
Their results proved that, the introduction of
epidural needle in Child’s A patients was
without
side
effects.
Secondly,
postoperative analgesia provided by a
single shot of epidural morphine combined
with small-dose ketamine is effective and
safe and represents an alternative
technique in cirrhotic undergoing any type
of major upper abdominal surgery.
16
Beers et al(29) reported that a low-lumbar
block level (L4-5) or saddle block provided
adequate anesthesia for ano-rectal surgery.
However, they reported that if anal
dilatation has to be done, saddle shaped
anesthesia in this case is not enough and
mid
or
low-lumber
blocks
are
recommended. In our study, the intrathecal
anesthesia was efficient in all groups except
for three patients in group I who required
sedative and analgesics during anal
dilatation. This failure in group I might be
due to the drug rather than block technique
applied. Plain ropivacaine produce variable
anesthesia secondary to limited caudal
spread(17).
Pruritus is a common complication when
intrathecal opioids are used. Liu(1) found
that the addition of 20 µg of fentanyl
intrathecally led to pruritus in all of their
patients. In the current study, pruritus was
reported in 3 patients (15%) of group I
patients and 4 patients (20%) in group II.
Pruritus was for a short duration and of mild
intensity, and needs no treatment. No
incidence
of
Transient
Neurological
Symptoms (TNSs) or post-spinal headache
was reported in any patient in the two
groups. Yegin et al(30) reported that, the
incidence of TNS among 86 TURP patients
under
hyperbaric
ropivacaine
spinal
anesthesia was seldom. Lim and Yoo(31)
found that, among 960 patients undergoing
ambulatory surgery under either saddle
shaped or low-lumber spinal anesthesia,
incidence of post-spinal headache showed
no difference (2.5% vs 2.3%). They found
that, no cases were reported in the first
postoperative day, 70% in the second day
and 26% in the third day. The incidence of
post-spinal headache in the present study
was nil in either group, a result which was
also obtained in the work carried out by
Cappelleri et al(32).
The present study supports the safety of
practicing spinal anesthesia in cirrhotic
patients in anorectal surgery. This result is
supported by the work carried by Siniscalchi
et al(33). They compared the intraoperative
effects of combined epidural-general versus
general anesthesia during major liver
surgery. Group A received general
anesthesia 15 minutes after placement of
an epidural catheter (T9-T10). Continuous
epidural infusion was initiated before
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Alexandria Journal of Anaesthesia and Intensive Care
surgical incision and continued with 0.2%
naropine (7 ml/h) until the end of the
operation. Group B (GA) received general
anesthesia with fentanyl doses according to
haemodynamic parameters. Pain intensity
on recovery in patients who received
epidural anesthesia was lower both at rest
and on movement. Only the patients in
Group B required additional analgesics. No
motor blockade was observed in either
group. Nausea and vomiting were more
frequent in Group B; hypotension was more
frequent in Group A. The study confirmed
the safety of low thoracic epidural
anesthesia
in
liver
surgery,
and
recommended its use as a fixed element of
anesthesia for liver patient without fear of
developing epidural haematoma or the
occurrence of severe haemodynamic
changes.
In conclusion, the practice of spinal
anesthesia in patients with liver cirrhosis of
Child-A severity is a reliable anesthetic
technique and no complications were
reported. The hyperbaric ropivacaine
produced more predictable and reliable
sensory and motor block, with faster onset,
than a plain solution. Moreover, the speed
of recovery from both sensory and motor
block is significantly better in hyperbaric
ropivacaine. This clinical profile of the
hyperbaric ropivacaine gives reasonable
choice for cirrhotic patients in case of
surgery to the ano-rectal area.
5.
6.
7.
8.
9.
10.
11.
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