Epidural Analgesia

British Journal of Anaesthesia 87 (1): 4761 (2001)
Safety and efcacy of postoperative epidural analgesia

R. G. Wheatley1* , S. A. Schug
and D. Watson2
Acute Pain Management Unit, York District Hospital, York YO3 7HE, UK. 2Section of Anaesthetics,
Department of Pharmacology, University of Auckland, PO Box 92019, Auckland, New Zealand
*Corresponding author: The Old Barn, Main Street, Shipton, York YO30 1AA, UK
Br J Anaesth 2001; 87: 4761
Keywords: literature review
Effective analgesia for postoperative pain relief after major

surgery has been a practical proposition with epidural
administration of local anaesthetic (LA) and opioid drugs
since the early 1980s. Although epidural administration is
perceived by 80% of UK anaesthetists as the ideal analgesic
technique for upper abdominal surgery,34 there are many
patients undergoing major surgery who do not receive this
form of analgesia. In a recent survey of UK practice, only
15% of patients undergoing abdominal surgery had epidural
analgesia in the 12 hospitals sampled.31 The main factor
which has limited the use of epidural analgesia has been the
difculty in making a reasonable risk/benet analysis about
the technique, which has resulted in clinicians constantly
asking whether epidurals are effective for postoperative
pain relief and whether the technique is safe.
This review considers the efcacy and safety of epidural
analgesia in patients recovering from major surgery and is
based on a computerized search of the literature from 1976
to 2000 (EMBASE/Medline). The nal section will deal
with the organizational issues which need to be considered
to maximize efcacy and safety and is based on the authors'
joint experience of supervising acute pain services (APS) in
New Zealand and the UK; these services have been
responsible for pain relief in over 20 000 patients nursed
on general postoperative wards.
Efcacy
Efcacy has been dened as `the ability of an intervention to
produce the desired benecial effect in expert hands and
under ideal circumstances'. It is important to bear this
denition in mind as the published results on efcacy are
usually based on expert practice in optimal conditions. The
difculties in making this transition from the controlled
setting of a clinical trial to routine clinical practice have
been highlighted by the results of recently published
audits,4 124 which have demonstrated a failure rate of
3050% for epidural analgesia.
The ideal epidural analgesic technique for major surgery
would provide effective pain relief with minimal side
effects and high levels of patient satisfaction. It would

also obtund central sensitization and pain-induced organ
dysfunction, leading to improved outcome. This topic is
covered in the accompanying review in this issue on
postoperative pain relief and surgical outcome83. It is selfevident that the primary measure of efcacy of any
analgesic regimen is pain relief. However, pain is a
complex, subjective experience which has proved difcult
to measure in a reproducible way. Early studies of
postoperative analgesia relied on measurement of pain
scores at rest and surrogate measures, such as respiratory
spirometry. Reliance on measuring pain scores at rest
resulted in failure to identify those techniques which
allowed patients to mobilize and cough effectively, i.e.
techniques that provided dynamic pain relief.42 Total
dynamic pain relief, i.e. complete absence of pain on
moving and coughing after major upper abdominal surgery,
can be produced in the intensive care environment by the
use of large doses of opioid and LA drugs. This is an
unrealistic aspiration for a ward-based analgesic technique,
as high doses of these drugs are associated with an
unacceptable incidence of hypotension and respiratory
depression. A more realistic approach is to measure pain
on movement or coughing and to aim for a patient who can
mobilize, take deep breaths and cough effectively and who
scores 3 or less out of 10 on a visual analogue or numerical
rating scale measured on movement.133 Although many
studies have used spirometric assessment as an outcome
measure, a recent meta-analysis cast doubt on the validity of
using these techniques as a surrogate measure of the efcacy
of epidural analgesia.9
The difculty with interpreting the available data on
efcacy is that epidural analgesia is not a single entity but
can be provided by a number of pharmacological agents
administered into different levels of the epidural space
before or after surgical incisions for a wide variety of
operations. In this section of the review we consider the
evidence from randomized controlled trials (RCTs) in
which dynamic pain relief was an outcome measure, in
order to assess the factors which modify the effectiveness of
The Board of Management and Trustees of the British Journal of Anaesthesia 2001
Wheatley et al.
Table 1 RCTs comparing lipophilic opioid epidural infusions with intravenous or patient-controlled intravenous opioids with dynamic pain relief as an
outcome measure. NS difference=no signicant difference; PCEA=patient controlled epidural anaesthesia
Reference
No. of
patients
Epidural regimen
Site of
insertion
Type of
surgery
Comparator
Dynamic
pain relief
compared with
control group
Comments
99
20
Fentanyl infusion 100 mg h1
Lumbar
Knee
i.v. fentanyl
infusion100 mg h1
NS difference
NS difference in plasma
concentrations
66
Fentanyl infusion 1 mg kg1 h1
Lumbar
Lower
abdominal
i.v. PCA morphine
Epidural more
effective
13
36
Fentanyl infusion 50 mg h1
Thoracic
Thoracic
i.v. PCA morphine
Epidural more
effective
36
40
Fentanyl PCEA 20 mg bolus
Lumbar
Lower
abdominal
I.v. PCA fentanyl

20 mg bolus
Epidural more
effective at
812 h
Reduced fentanyl consumption

in the epidural group
28
32
Alfentanil PCEA 250 mg bolus
Thoracic
Major
abdominal
i.v. alfentanil PCA

250 mg bolus
NS difference
Reduced alfentanil consumption

in the epidural group
107
50
Sufentanil infusion 0.2 mg kg1 h1
Lumbar
Major
abdominal
i.v. sufentanil
0.2 mg h1
NS difference
NS difference in opioid dose
38
84
Fentanyl PCEA 20 mg bolus
Lumbar
Lower
abdominal
I.v. PCA morphine
Epidural more
effective for 21 h
nociceptive input but do not cause motor or sympathetic

blockade.
Despite the initial enthusiasm for epidural opioids, with
their promise of profound, long-lasting analgesia with
minimal side-effects, there is still considerable debate
about their place in postoperative pain management.29 44
Opioid-based techniques have been used widely in the
USA and Australia and are usually based on bolus
administration of drugs such as morphine, diamorphine
and pethidine or the continuous infusion of lipophilic
opioids such as fentanyl or sufentanil.
Although bolus epidural opioids may produce longerlasting analgesia with smaller doses than intermittent i.m.
opioids,29 there is less convincing evidence that they
improve the quality of analgesia when the technique is
compared to i.v. patient-controlled anaesthesia (PCA).60
The RCTs of continuous infusions of lipophilic opioids
compared with i.v. or patient-controlled i.v. opioids in
which pain on coughing or movement was assessed are
shown in Table 1.
The evidence for a spinal rather than a systemic action of
fentanyl is conicting. Although signicant differences in
efcacy were not demonstrated when fentanyl or sufentanil
were administered epidurally or i.v. after knee99 or major
abdominal28 107 surgery, epidural fentanyl produced more
effective dynamic pain relief than i.v. PCA morphine or
fentanyl in lower abdominal3 36 38 and thoracic13 surgery. In
the majority of studies in which plasma concentrations have
been measured,11 99 137 there was no signicant difference
in plasma concentrations between the two routes of
administration. Furthermore, plasma concentrations of
epidural analgesia such as the choice of drugs, the site of

epidural insertion in relation to the surgical incision and the
timing and method of drug delivery.
Choice of drug
Local anaesthetic
Epidural LA drugs administered alone have never become

widely used for routine postoperative analgesia because of
the signicant failure rate resulting from regression of the
sensory block110 and the unacceptable incidence of motor
blockade and hypotension. In a study of patients undergoing
thoracic surgery, despite the infusion of bupivacaine
37.550 mg h1 via a thoracic epidural, 30% of patients
required opioid supplementation for inadequate analgesia
and 80% had signicant hypotension.33 Similar results were
also found when bupivacaine 2445 mg h1 or ropivacaine
1030 mg h1 was infused epidurally after upper131 141 and
lower53 108 abdominal surgery. In an opioid-free postoperative analgesic regimen, infusion rates of bupivacaine
1012.5 mg h1 supplemented by systemic non-steroidal
anti-inammatory drugs were found to be ineffective in
lower abdominal surgery.25
Opioids
The use of epidural analgesia for pain relief was

revolutionized by the use of epidural opioids after the
discovery of opioid receptors in the dorsal horn of the spinal
cord. Opioids have both presynaptic and postsynaptic
effects in the dorsal horn and affect the modulation of
48
reduced concentrations of less lipophilic opioids, such as

50 mg ml1 of morphine39 42 and diamorphine,101 have been
shown to be effective.
The optimal dose of the LA component of the epidural
mixture is becoming clearer. In two postoperative studies in
which pain relief on movement37 52 was not signicantly
better in the combination group, the concentration of
bupivacaine used was 0.1% or less and it was delivered as
patient-controlled epidural anaesthesia (PCEA) without a
background infusion. A dose of 412 mg h1 of bupivacaine,
when combined with morphine 50 mg ml1,42 diamorphine
80 mg ml1,101 fentanyl 10 mg ml1,119 sufentanil
1 mg ml1,168 and administered via a thoracic epidural
catheter, has been shown to provide effective dynamic pain
relief. The addition of opioid, therefore, signicantly
reduces the hourly requirement of bupivacaine from
2545 mg h1 when used alone.33 108 131
In a recent study, in which a direct search procedure was
used to determine the optimal combinations of thoracic
epidural bupivacaine and fentanyl after major abdominal
surgery, the two most effective regimens were bupivacaine
8 mg h1 and fentanyl 30 mg h1 or bupivacaine 13 mg h1
and fentanyl 25 mg h1; both infused at 9 ml h1.40
Although the doses of LA are small, it is likely that the
newer LA drugs, levobupivacaine and ropivacaine, will be
used increasingly because of their improved safety margin
and, in the case of ropivacaine, the potential advantage of
less motor blockade. Although this latter advantage appears
to be relevant at the higher concentrations used for
intraoperative analgesia, the differences between the drugs
are less marked at the dilute concentrations used for
postoperative analgesia. In a study after major abdominal
surgery, 0.2% ropivacaine was not signicantly different, in
terms of analgesia or motor blockade, from 0.125%
bupivacaine when both were combined with fentanyl
2 mg ml1.14
fentanyl were usually above the minimum effective analgesic concentration of 0.231.18 (mean 0.63) ng ml1 for
i.v. fentanyl.62
On the basis of the available studies, the benets of
administering lipophilic opioids alone by the epidural route
appear to be marginal, or unproven in the case of upper
abdominal surgery, and in many situations will not
outweigh the risks of the more invasive route of administration.
Opioidlocal anaesthetic combinations
Epidural infusions of LAopioid combinations are the most

commonly used epidural technique in the UK34 and
Australia,35 being used by 97% of anaesthetists who use
the technique. Their use is based on the clinical observation
that the combination of LA and opioid drugs limits the
regression of the sensory block seen with LAs alone65 and
improves the quality of dynamic pain relief.42 However,
there are major regional and national differences in the
choice of opioid and LA drugs used for postoperative
epidural analgesia. In a UK survey, 40% of anaesthetic
departments used diamorphine and 51% used fentanyl in
combination with LA drugs.129
The RCTs comparing LAopioid combinations and LA
or opioids alone with dynamic pain relief as an outcome
measure are shown in Table 2.
The majority of studies show that the use of a mixture of
LA and opioid is associated with signicantly better
dynamic
pain
relief
after
lower
or
upper
abdominal,39 42 101 119 145 146 168 orthopaedic79 87and
thoracic95 115 168 surgery than the components of the
mixture infused alone.
However, in a within-patient crossover study, Torda and
colleagues could not demonstrate any difference in efcacy
between bolus doses of fentanyl 50 mg, bupivacaine 50 mg
or a mixture of both.157 Similarly, Mahon and colleagues
were unable to demonstrate any improvement in efcacy by
adding 0.10.2% bupivacaine to fentanyl 10 mg ml1 after
the rst 2 h after thoracotomy.103
Epidural analgesia with LAopioid combinations has
been shown to be signicantly better than i.v. PCA
morphine in providing dynamic pain relief after major
abdominal surgery18 97 104 113 (Table 3).
Is there an optimal combination of opioid and LA for
epidural analgesia? Despite differences in epidural to
systemic potency between different opioid drugs, there are
no RCTs, with dynamic pain relief as an outcome measure,
which compare the efcacy of different epidural LAopioid
combinations. However, it is clear that the co-administration of LA with opioid signicantly reduces the opioid
requirement of all opioids studied. Many of the early studies
used a fentanyl concentration of 10 mg ml1 on the basis of a
dose-nding study of epidural fentanyl used alone.165 In a
subsequent dose-nding study, in which fentanyl was
combined with 0.125% levobupivacaine, an optimal concentration of 4 mg ml1 was recommended.145 Similarly,
Site of insertion
A meta-analysis of studies comparing the thoracic or lumbar
approaches to the epidural space for opioids alone failed to
demonstrate any signicant improvement in analgesia when
the thoracic approach was used.9
There are no RCTs comparing LAopioid combinations administered via the thoracic and lumbar
approaches. Nevertheless, the use of the thoracic rather
than the lumbar approach to the epidural space has been
one of the major changes in anaesthetic practice over
the last 20 yr and has been used in the majority of
studies that have demonstrated improved dynamic pain
relief.39 42 95 97 101 104 113 115 119 145 146 168 This
technique has a number of potential benets when used
for the administration of LAopioid mixtures. The
thoracic approach facilitates the incision-congruent
administration of lipophilic opioids in small doses and
minimizes motor and sympathetic blockade of the lower
49
Wheatley et al.
Table 2 RCTs, comparing LAopioid combinations with epidural opioids or local anaesthetic alone, with dynamic pain relief as an outcome measure.
NS difference = no signicant difference
Reference
No. of
patients
Epidural regimen
Type of
surgery/site
of epidural
Comparator
Dynamic pain
relief compared
with control group
Comments
146
22
Morphine 500 mg h1
0.5% bupivacaine 25 mg h1
Upper
abdominal/thoracic
0.5% Bupivacaine
25 mg h1
Combination more
effective
2 patients withdrawn
because of hypotension
or respiratory depression
42
24
Morphine 200 mg h1
Major
abdominal/thoracic
Morphine 200 mg h1
Combination more
effective
39
64
Morphine 200 mg h1
0.25% levobupivacaine
10 mg h1
Major
abdominal/thoracic
Morphine 200 mg h1
Combination more
effective for the
rst 8 h
101
40
Diamorphine 250600 mg h1
0.167% bupivacaine
512 mg h1
Upper
abdominal/thoracic
Diamorphine
250600 mg h1
Combination more
effective
53
66
Pethidine 1 mg ml1
0.1% bupivacaine
PCEA: no background
5 ml/15 min
Thoracic/thoracic
Pethidine
NS difference
119
90
Fentanyl 40 mg h1
Major
abdominal/thoracic
Fentanyl 40 mg h1
Combination more
effective for the
rst 24 h
157
24
Fentanyl 50 mg + bupivacaine
12.5 or 25 mg bolus doses
Major abdominal
surgery/thoracic
Fentanyl 50 mg
NS difference
95
24
Fentanyl PCEA
0.010.1% bupivacaine
10 ml h1
Thoracic
Fentanyl PCEA
Combination more
effective
Optimal bupivacaine
dose 5 mg h1
37
60
Fentanyl 2 mg ml1
bupivacaine 0.05%
PCEA: no background
5 ml/10 min
Lower
abdominal/lumbar
Fentanyl 4 mg ml1 or
0.15% bupivacaine
PCEA
NS difference
Signicantly reduced
fentanyl or bupivacaine
doses when combination
used
103
106
Fentanyl 50100 mg h1
0.10.2% bupivacaine
520 mg h1
Thoracic/thoracic
Fentanyl 50100 mg h1
NS difference after
the rst 2 h
88
68
Fentanyl 4 mg ml1
levobupivacaine 0.125%
PCEA 4 ml h1
+ 2 ml/10 min bolus
Arthroplasty/lumbar
Fentanyl 4 mg ml1 or
0.125% levobupivacaine
PCEA
Combination
more effective
NS difference in
opioid doses
145
259
Fentanyl 14 mg ml1
0.2% ropivacaine
PCEA 8 ml h1
+ 4 ml/30 min bolus
Major
abdominal/thoracic
Ropivacaine 0.2%
Combination
more effective
Optimal fentanyl
dose 4 mg ml1
115
50
Sufentanil 0.8 mg ml1

0.125% bupivacaine
612 mg h1
Thoracic/thoracic
Sufentanil 0.8 mg ml1

or 0.125% bupivacaine
510 ml h1
Combination
more effective
0.125% bupivacaine
ineffective
168
100
Sufentanil 1 mg ml1
0.17% bupivacaine
PCEA 5 ml h1
+ 2 ml/20 min bolus
Thoracic abdominal
0.17% Bupivacaine
Combination
more effective
Less supplementary
analgesia required
79
30
Sufentanil 59 mg h1
0.1% ropivacaine
59 mg h1
Orthopaedic/
lumbar
0.1% Ropivacaine
Combination
more effective
Less supplementary
analgesia required
50
Less supplementary
analgesia required
NS difference in
drug consumption

Table 3 RCTs comparing epidural LA- opioid combinations with i.v. PCA with dynamic pain relief as an outcome measure
Reference
No. of
patients
Epidural regimen
Site of
insertion
Type of
surgery
Post-operative
analgesia
Dynamic pain
relief
97
54
Morphine 300 mg h1
0.1% bupivacaine
10 mg h1
Thoracic
Major abdominal
I.v. PCA morphine
Better in the epidural group
18
40
Morphine 400 mg h1
0.125% bupivacaine
6 mg h1
Lumbar
Aortic
I.v. PCA morphine
113
60
Morphine 250 mg h1
0.125% bupivacaine
12.5 mg h1
Thoracic
Major abdominal
I.v. PCA morphine
104
70
PCEA sufentanil
0.5mg ml1
+ 0.125% bupivacaine
35 ml h1
Thoracic
Major abdominal
surgery
I.v. PCA morphine
limbs. Although initially seen as a disadvantage because

of the attendant hypotension, the importance of a
controllable degree of sympathetic blockade in the
attenuation of the adverse adrenergic effects on the
cardiovascular and gastrointestinal systems is now being
realized.128
Method of drug delivery

Bolus versus infusion
postoperative epidural analgesia is usually administered via

a continuous infusion to maintain a level of analgesia and to
minimize the cardiovascular and respiratory effects of bolus
doses of LA and opioid respectively. Intermittent bolus
dosing of LA alone has been shown to minimize block
regression and marginally improve analgesia compared with
a continuous infusion of the same hourly dose in patients
undergoing lower abdominal surgery.48 However, there was
no difference in pain scores on coughing between the two
groups, and this technique has not been studied in patients
receiving epidural LAopioid combinations for upper
abdominal surgery.
Pre- or post-incisional epidural analgesia

In order to see a pre-emptive effect with an analgesic
intervention, it is necessary to provide good analgesia
with inhibition of central sensitization extending into
the postoperative period.169 This may explain the lack
of pre-emptive effect when an epidural is given before
or after surgical incision and analgesia is provided in
the postoperative period by i.v. PCA morphine51 126
(Table 4).
However, no signicant difference in dynamic pain relief
was seen when bupivacaine and morphine were given
before and after incision and continued into the postoperative period41 or when bupivacaine alone was given
followed by PCEA with fentanyl and bupivacaine.2 Two
recent studies have demonstrated a pre-emptive effect.
Using a mixture of ketamine, bupivacaine and morphine,
Wu and colleagues demonstrated a statistically signicant
improvement in analgesia in the pre-incisional group after
upper abdominal surgery during the rst postoperative
day.171 However, the differences in clinical terms were
marginal as patients in both groups had good dynamic pain
relief. Patients recovering from radical prostatectomy, all of
whom had an aggressive postoperative epidural analgesic
regimen, had signicantly less pain in hospital and 9.5 weeks
later if they had had epidural fentanyl or bupivacaine
administered before surgical incision.61 Although this is one
of the few studies demonstrating a clinically signicant preemptive effect, its conclusions are limited by the fact that
pain scores were measured at rest.
PCEA with or without a background infusion
Allowing patients to have control of their analgesia has

become an important principle in acute pain management.
Although the role and optimal regimen of PCEA after major
surgery have not yet been fully claried, the technique has
the practical safety advantage of permitting bolus doses
which do not require to be mixed on the ward. The
importance of a background infusion when using an
LAopioid combination was emphasized in a recent study
in patients recovering from gastrectomy when PCEA alone
was shown to be less effective in reducing pain on coughing
than PCEA with a background infusion.86
Choice of adjuvants
In addition to LA agents and opioids, a number of agents

have been used as adjuvants to improve the efcacy of
epidural analgesia. These include ketamine [antagonist of
NMDA (N-methyl-D-aspartate)], midazolam [agonist of
GABA (g-aminobutyric acid)], clonidine (a2 agonist) and
adrenaline.
The results of RCTs of adjuvant agents added to
LAopioid combinations are shown in Table 5.
51
Wheatley et al.
Table 4 RCTs of pre- versus post-incisional administration of epidural analgesia with dynamic pain relief as an outcome measure. NS difference = no
signicant difference
Reference
No. of
patients
Epidural regimen
Site of
insertion
Type of
surgery
Postoperative analgesia
Dynamic pain
relief
51
40
0.5% bupivacaine 20 ml
Lumbar
Lower abdominal
PCA i.v. morphine
NS difference
126
25
+ fentanyl 50 mg
Lumbar
Lower abdominal
PCA i.v. morphine
NS difference
l41
32
+ morphine 2 mg
Thoracic
Major abdominal
Epidural morphine + bupivacaine
NS difference
45
bupivacaine 8 ml + epinephrine
Thoracic
Thoracic
PCEA
fentanyl + bupivacaine + epinephrine
NS difference
171
60
Ketamine + morphine +
bupivacaine
Thoracic
Upper abdominal
surgery
Ketamine + morphine + bupivacaine

twice per day
Signicantly better
in the pre-incisional
group
Table 5 RCTs of adjuvant therapy plus LAopioid combinations with dynamic pain relief as an outcome measure
Reference
No. of
patients
Epidural regimen
Site of
insertion
Type of
surgery
Adjuvant
Dynamic pain
relief
30
91
PCEA morphine 20 mg ml1 +

0.08% bupivacaine +
epinephrine 4 mg ml1
Thoracic
Major surgery
Ketamine 400 mg ml1
Better in the ketamine group
116
24
Fentanyl 20 mg h1 +
Thoracic
Major abdominal
and thoracic
Epinephrine 2 mg ml1
Better in the epinephrine group
109
24
Morphine 100 mg h1 +
bupivacaine 5 mg h1
Thoracic
Lower abdominal
Clonidine 18.75 mg h1
Better pain relief but more

hypotension
118
100
Fentanyl 10 mg h1 +
0.125% bupivacaine 7.5 mg h1
+ PCEA fentanyl
Thoracic
Lower abdominal
Clonidine 2, 3 or 4 mg ml1
5 ml h1
Better pain relief with

clonidine 20 mg h1
but more hypotension
Although ketamine 400 mg ml1, used as an adjuvant to a

low-dose epidural infusion of morphine, bupivacaine and
adrenaline, enhanced dynamic pain relief,30 concerns have
been expressed about the lack of data on the potential
neurotoxicity of ketamine,173 Similarly, enthusiasm for the
improved efcacy seen with the addition of clonidine
1820 mg h1 to thoracic epidural analgesia118 109 is
tempered by concerns about the increased incidence of
hypotension and the increased level of surveillance needed.
Although midazolam and verapamil have been used with
bupivacaine, there are no data on their use as adjuvants to
continuous epidural analgesia with LAopioid combinations.
The addition or removal of adrenaline to a low-dose
epidural mixture of bupivacaine and fentanyl has been
investigated by Niemi and Breivik in a double-blind
crossover study after major surgery.116 The use of
epinephrine was associated with minimal regression of the
sensory block, markedly improved pain relief on coughing
and reduced serum fentanyl concentrations. Despite concerns about the safety of adding vasoconstrictors to epidural
mixtures, Breivik and colleagues have used this triple-
component epidural mixture in over 6000 patients with

apparent safety.20
Safety
There are a number of complications that can result from
epidural analgesia, some of which are of major concern
because of their potential to cause permanent neurological
damage. Such adverse effects can be related to needle and
catheter insertion, the presence of the catheter in the
epidural space or the drugs infused, including drug errors.
The introduction of Acute Pain Services has enabled early
recognition of these diverse and, in some cases, extremely
rare complications so that corrective action can be taken to
prevent permanent harm.
Incidence of serious neurological complications due

to epidural analgesia
Because of the rarity of permanent neurological damage
resulting from epidural analgesia, it is difcult to estimate
its incidence. In a combined series of more than 50 000
52
drainage needles and catheters in 530 anaesthetized patients

undergoing neurosurgery reported no cases of nerve injury
in the immediate postoperative period or within 1 yr of
surgery.63
epidural anaesthetics, only three patients suffered permanent leg weakness (0.006%).80 A retrospective study of
170 000 epidural anaesthetics in Finland over 10 yr and of
the resulting claims for compensation revealed nine serious
complications (0.005%): one case of paraparesis, one case
of permanent cauda equina syndrome, one case of peroneal
nerve paresis, one case of neurological decit, two bacterial
infections, two acute toxic reactions related to the anaesthetic solutions and one overdose of epidural opioid.6
However, the incidence may be underestimated by such
retrospective reviews. A prospective French study, involving 30 413 epidurals inserted over a 5-month period,
revealed an incidence of severe complications of 0.04%:
three cardiac arrests, four convulsions and six neurological
injuries.8 Although Giebler and colleagues found no
permanent neurological decit in a study of 4185 epidurals,
the upper limit of his 95% condence interval gives a
predicted maximal risk for permanent neurological complications of 0.07%.59 Dahlgren and Tornebrandt similarly
reported an incidence of persistent neurological decit of
0.03% after 9232 epidurals;43 this is 10 times the risk given
by Kane80 and by Aromaa and colleagues.6
However, on many occasions the association between
epidural anaesthesia/analgesia and serious neurological
sequelae is only a temporal one and might be inappropriately suspected to be causal, as described in various case
reports.16 94 100 106 132
Transient neuropathy
Transient neuropathy with eventual full recovery occurs

more commonly but is still relatively infrequent; a recent
large prospective multicentre series involving 30 413
epidural anaesthetics reported ve cases of radiculopathy
(0.016%), over 50% recovering completely within
3 months.8 This incidence is similar to previously published
large studies on transient neuropathy: 4 out of 17 439
patients (0.023%)155 and 0.013% from a retrospective study
of 1 304 214 epidurals.172 Other much smaller studies report
an incidence of 0.240.56%.59 138 A recent paediatric study
found an incidence of up to 3%, but this involved
small numbers of patients.121 After certain operations,
such as tibial fracture xation, epidural analgesia has been
implicated in a higher incidence of neurological complications.73 However, a retrospective study demonstrated no
signicant association between the development of peroneal
nerve palsy after total knee replacement and the use of
postoperative epidural analgesia66.
Adverse events due to the presence of an indwelling

catheter in the epidural space
Spinal haematoma
Adverse events due to the insertion of needle and

catheter
Puncture of epidural vessels during catheter placement

occurs during 312% of attempts.143 However, the
subsequent development of a spinal haematoma causing
neurological damage is a rare complication. If not detected
and treated early, it results in irreversible paraplegia. The
incidence of clinically apparent epidural haematoma is
unknown, as any study attempting to quantify it would have
to involve an enormous number of patients. However, its
occurrence does seem to be increasing, possibly as a result
of increased use of regional anaesthesia in combination with
altered coagulation [in particular low-molecular weight
heparin (LMWH)] or of better reporting of the complication.
The risk of developing a spinal haematoma can be
quantied only by either studying large numbers of routine
or at-risk patients or collecting case reports of spinal
haematoma after epidural blockade. The reported incidence
varies greatly between studies. Vandermeulen and colleagues combined 18 studies involving 200 000 patients
who received epidural analgesia and found no incidence of
epidural haematoma.161 In a review including 13 case series
that involved >850 000 epidurals, there were only three
cases of haematoma (0.0004%).152 At the other extreme,
three cases of epidural haematoma were reported after 9232
(0.03%) epidural insertions;43 an even higher incidence, of
two cases out of 1014 (0.2%) insertions, has also been
reported.144 On the basis of all available information, Tryba
Dural puncture
Dural puncture occurs in 0.321.23% of epidural

placements59 138 155 172 and can result in the development
of a postdural puncture headache. Rarely, subdural
haematoma that can result in neurological deterioration
has been described after dural puncture58 75; its incidence
may be less with loss of resistance to saline than to
air.46 81 130 There is also a risk of pneumocephalus if air is
used,7 105 which can result in serious complications.93 127 150
The use of saline may again help to reduce the incidence of
this and other complications that have been associated with
the use of air, notably spinal cord and nerve root compression and venous air embolism.76 78 134 148 In addition,
accidental pleural puncture during epidural catheter insertion has been described,57 175 as has haemothorax.74
Direct trauma
Direct trauma to the spinal cord or peripheral nerves due to

the needle or catheter is extremely rare, but has been
reported. Epidural catheterization is most frequently
performed in the awake patient to avoid this risk of
neurological damage. This problem, which was highlighted
in a recent case report,22 is still being debated.54 In support
of epidural insertion in the anaesthetized patient, a recent
study involving the placement of cerebrospinal uid
53
Wheatley et al.
haematoma in the literature and none in a review of more

than 5000 patients.143
LMWH. At least 40 cases of spinal haematoma have been
reported in the USA with neuraxial anaesthesia under
LMWH prophylaxis.68 These were probably related to
intraoperative or early postoperative administration, a
twice-daily dosing schedule and concomitant antiplatelet
therapy in the USA, as the European experience, with
adherence to strict guidelines, is quite different. The worst
incidence of spinal haematoma has been estimated at 1 in
3100 cases with continuous epidural analgesia under
LMWH cover in the USA.140 New recommendations follow
the European guidelines, recommending 24-hourly dosing
and a 12-h interval between LMWH injection and insertion
or removal of the catheter.
Antiplatelet medications. It is relatively safe to insert an
epidural whilst the patient is receiving antiplatelet medication; this is supported by several large studies involving
obstetric and surgical patients.5 72 No increased incidence of
bloody tap was observed during epidural insertion in 1000
patients on antiplatelet medication, suggesting no difference
in traumatic needle/catheter placement.70
has given the best estimate for the risk of a spinal

haematoma after epidural analgesia to be 1:150 000 at the
upper 95% condence interval.158
Examination of case reports of spinal haematoma has
revealed potential risk factors, notably haemostatic abnormalities and/or anticoagulation, in particular the timing of
catheter insertion and removal in relation to the administration of anticoagulants. In 61 cases of spinal haematoma
associated with epidural/spinal anaesthesia, 42 (68%) of
them had evidence of haemostatic abnormality: 30 had
received heparin and 12 had evidence of coagulopathy or
were treated with antiplatelet agents, thrombolytics or
anticoagulants.161 Forty-six of these had undergone epidural
anaesthesia, 32 with the use of an epidural catheter. In
nearly 50% of these 32 patients, the spinal haematoma
occurred immediately after removal of the catheter, nine
being removed when heparin concentrations were
therapeutic. This demonstrates that development of a
haematoma is not just related to insertion but also (of
equal importance) to removal of the epidural catheter.
Overall, 87% of epidural haematomas were related to some
haemostatic abnormality or procedure difculty. Literature
concerning obstetric patients revealed 17 cases of haematoma after epidural catheter insertions, of which 14 (82%)
had a bleeding diathesis.135
However, three studies involving over 5000 systemically
anticoagulated patients and one study of 805 patients
taking antiplatelet medication who received central neuraxial blockade described no cases of spinal
haematoma.10 70 117 123 Furthermore, four studies, involving
intraoperative high-dose heparin during cardiac surgery in
776 adult patients and 234 paediatric patients who received
central neuraxial blockade, failed to demonstrate any spinal
haematoma formation, provided there were no other risk
factors.102 121 136 160
The situation has changed dramatically with the introduction of LMWH as routine thromboembolic prophylaxis.
A subsequent surge of epidural haematomas has ignited a
very complex debate.67 For detailed current recommendations, the reader is directed to a recent review by Horlocker
and Wedel.69 This review can be summarized as follows.
Oral anticoagulation. Catheter placement/removal
should not be performed in fully anticoagulated patients.
Epidural insertion is relatively safe, if low-dose warfarin
(35 mg day1) is started after catheter insertion (192
patients).71 An international normalized ratio (INR) of <1.4
at the time of catheter removal resulted in no case of spinal
haematoma (459 patients).170
Intravenous and subcutaneous standard heparin.
Systemic heparinization is safe for vascular surgery, if
administered 60 min after catheter placement if coagulation
is closely monitored and if the catheter is removed when
circulating heparin concentrations are low.123 Low-dose
subcutaneous heparin in combination with epidural analgesia is safethere were only three cases of spinal
Infection
Infection can be introduced into the epidural space from an

exogenous source via contaminated equipment or drugs, or
from an endogenous source, leading to bacteraemia, which
seeds to the insertion site. Alternatively, the catheter can act
as a wick through which infection tracks down from the
entry site on the skin to the epidural space. Infection can
result in meningitis (if the dura is breached) or epidural
abscess formation, resulting in cord compression. It has
been demonstrated that the spread of streptococci from the
anaesthetist's buccal mucosa can cause epidural infections.139 However, facemasks have not been shown to
reduce the incidence of neuraxial infections.
Serious neuraxial infections after epidural anaesthesia
have been reported as being rare. A review of 50 000
epidural anaesthetics did not show a single epidural or
intrathecal infection80 and, more recently, Dahlgren and
Tornebrandt reported no cases of epidural abscess out of
9232 epidural insertions.43 However, more recent, smaller
studies cite the incidence as being closer to 1:10 000. A
prospective Danish study, involving 17 372 epidural
catheters, reported the incidence of epidural abscess to be
1:1930 (0.05%),163 other studies giving similar gures of
2:13 000 and 2:2000.84 133 The ndings of the Danish study
suggest that patients with epidural abscess had a longer
mean catheterization time than the population mean, the
majority of such patients were immunocompromised by one
or more complicating diseases (malignancy, diabetes,
multiple trauma, chronic obstructive respiratory disease)
and perioperative anticoagulant therapy was involved in
most cases.163 There were no reports of abscess formation in
patients with catheters in situ for 2 days or less.
Predominance of immunocompromised patients has also
54
been found in previous studies.47 82 The risk of persistent

neurological decit from an epidural abscess is almost 50%,
which may be explained by the long period from diagnosis
of an epidural abscess to intervention;163 this outcome has
not improved since the period 19471974.85
Epidural analgesia in patients with known systemic or
localized infection remains controversial. Many anaesthetists have considered sepsis to be a relative contraindication
for epidural anaesthesia. It is generally recommended that
epidural catheterization should not be performed in patients
with untreated bacteraemia, unless there is an overwhelming
reason to do so.69 Jakobsen and colleagues, in a retrospective study of 69 patients with localized skin infections who
underwent repeated epidural catheterization, reported no
signs or symptoms of neuraxial infection.77 However,
another study reported three neuraxial infections related to
epidural catheterization in patients with localized infections.43 Small numbers in the studies make it difcult to
provide recommendations.
Any patient with local or systemic infection is potentially
at risk of developing neuraxial infection; extreme vigilance
must be maintained in the monitoring and detection of
epidural infection. There should be careful selection of
patients currently responding to antibiotic treatment of their
sepsis for which epidural analgesia is proposed. Also, the
potential unproven risk of neuraxial infection after intraoperative transient bacteraemia during an obstetric or
urological procedure should be considered. However,
short-term catheterization in these patients is probably
safe.69
effects. In addition, occasionally drug errors occur whereby

the wrong drug is administered via the epidural catheter,
sometimes resulting in tragic consequences. The incidence
of such cases remains unclear as there are very few case
reportsglucose,167 antibiotics,88 thiopentone,26 55 potassium chloride89 92 149 (resulting in paraplegia) and total
parenteral nutrition120 have all been inadvertently injected.
The use of pharmacy-prepared or commercially prepared
solutions, extreme care with labelling of epidural catheters
and drugs, checking procedures and the use of dedicated
pumps should help avoid these problems.
Respiratory depression
The side-effect of most concern with epidural opioids is

respiratory depression. Because of the hydrophilic nature of
some opioids, such as morphine, there is an increased
tendency for the drug to remain in the CNS, particularly the
cerebrospinal uid, resulting in possible cephalad spread
and delayed respiratory depression.
There is an abundance of literature devoted to neuraxial
opioids and the incidence of respiratory depression. One
Swedish review, encompassing 15 departments of anaesthesia, estimated an incidence of 0.250.4%, the major risk
factors being age over 70 yr and additional administration of
opioids by other routes.64 A Canadian questionnaire,
involving 56 teaching hospitals, cited an estimated incidence of 0.13%.176 Although the choice of opioid is
important, fentanyl or diamorphine being more lipophilic
and less likely to cause delayed respiratory depression, the
dose of drug given by continuous infusion is also important.
To emphasize this point, there has been a case report
describing three patients who developed severe respiratory
depression during an epidural infusion containing bupivacaine and fentanyl 2025 mg ml1.164
The actual, not estimated, incidence of respiratory
depression has been reported in numerous studies involving
data collection from an APS. The number of patients studied
varies between 1014 and 1 304 214, with a reported
incidence of 0.241.6%,24 56 125 133 144 154 172 often
associated with sedation.91 144 The higher gures are more
representative of the incidence using epidural morphine
infusion. However, with the administration of epidural
morphine <200 mg h1 the risk of respiratory depression is
probably no higher than with other epidural opioids.21 Using
a PCEA containing fentanyl and LA, the incidence is
reported as 0.3%.96
The quoted incidence of respiratory depression when
epidural analgesia is supervised by an APS is no higher
than the incidence of respiratory depression seen with
other forms of opioid analgesia.19 Regular monitoring of
respiratory rate and, more importantly, the level of
consciousness appears to be adequate to detect respiratory
depression, and is indicated for up to 12 h after a bolus
injection of morphine and for the entire duration of a
continuous infusion.
Catheter migration
After initial placement of the epidural catheter in the

epidural space, the tip of the catheter can move intrathecally. Similarly, i.v. migration can occur. Both must be
considered before any bolus dose is administered via the
epidural catheter by careful aspiration; a test dose of LA
containing epinephrine can also provide evidence of i.v.
migration by producing a transient tachycardia. These
techniques, and the use of low-dose LAopioid infusions,
may help to prevent dramatic complications, such as total
spinal anaesthesia with possible neurotoxicity90 and
seizures.15 107 147 Unintentional subdural catheter placement or migration can also lead to a high block requiring
intubation.27
The incidence of intrathecal migration has been reported
as 0.150.18%125 142 a similar gure of 0.18% has been
reported for intravenous migration.125
Adverse events related to epidural drug

administration
Drug errors
Most commonly, LAs, opioids and/or clonidine are infused

into the epidural space to provide postoperative analgesia.
All these drugs carry the potential for serious adverse
55
Wheatley et al.
higher incidence of 0.3 per 1000 with lidocaine.23 Cerebral

irritation after doses as low as 30 mg h1 has been
described,49 but this is still considerably higher than the
`optimal' dose of bupivacaine recommended by Curatolo
and colleagues for LAopioid combination.40 A case of
ropivacaine-induced seizure has been described after epidural anaesthesia.1
Table 6 Effective and safe management of ward-based epidural analgesia

Patient
Regimen
Staff
Monitoring
Audit
Informed consent
Careful selection based on a risk/benet analysis
and absence of contraindications
Sterile technique
Standard, pharmacy prepared or commercially produced
low dose LA opioid infusion
Bupivacaine 812 mg h1 plus fentanyl 24 mg ml1 or
morphine/diamorphine 50 mg ml1
Standard infusion pump (different from i.v. PCA pumps)
with PCEA facility
Identiable administration sets without injection ports
Bacterial lter
Transparent dressing
Training programme/protocols/acute pain handbook
with particular attention to:
Recognition and management of complications
including hypotension, respiratory depression, inadequate
analgesia and motor blockade
Concurrent thromboprophylaxis and anticoagulant therapy
Access to members of the acute pain team
24-h cover
Regular monitoring of dynamic pain scores, cardiorespiratory
parameters, sedation scores, dermatomal level and motor
blockade
Daily inspection of the epidural site
Twice daily review by the APT
Audit and feedback to anaesthetists, surgeons and nurses
Critical incident reporting
Motor blockade
Excessive lower limb motor blockade with controlled

infusion of epidural LAs is uncommon, occurring in only
in 3.0% of cases using low concentrations of bupivacaine.144 If motor blockade does occur, it may result in the
development of pressure areas on the heels32 122 151 and
deep venous thrombosis.166 Persistent motor blockade of
one or both lower limbs in a patient receiving a low dose
combination LAopioid thoracic epidural should always be
treated with suspicion. Stopping the epidural infusion
normally results in neurological improvement within 2 h.
If this does not occur, consideration should be given to
excluding a spinal haematoma or abscess. Ropivacaine may
produce less motor blockade compared with an equianalgesic dose of bupivacaine,174 especially if used in low
concentrations (0.1%) with fentanyl (2 mg ml1).98 Epidural
blockade has been blamed in occasional case reports for
masking the symptoms of compartment syndrome,112 153 156
although there have also been cases which have been
diagnosed successfully during epidural blockade.12 111
Hypotension
Accompanying the sensory and motor block of epidural LAs

are the sympatholytic effects due to blockade of the
sympathetic chain; this results in hypotension. If the block
height reaches the cardiac outow between T1 and T5, there
may be a marked hypotensive and bradycardic response,
particularly in the presence of hypovolaemia. The degree of
hypotension depends on the actual dose, lower concentrations of LA causing less effect on blood pressure.
Unopposed parasympathetically mediated bronchoconstriction has also been proposed as the cause of a case of severe
bronchospasm during epidural anaesthesia.162
Combining the results of three studies involving nearly
9000 patients, the incidence of hypotension during epidural
infusion of LA is 0.73% depending on the concentration
used (0.06250.25% bupivacaine) and the criteria for
hypotension.45 133 159 Use of a PCEA gave a 6.8% incidence
of hypotension.96
The routine use of epidural clonidine up to 900 mg as
boluses of 100 mg is likely to produce signicant
haemodynamic depression and sedation.50 17 114 When
infused at 20 mg h1 with bupivacaine and fentanyl, it was
shown to improve analgesia at rest and during coughing but,
again, was associated with signicant haemodynamic
changes.118
Organizational issues
Providing effective analgesia for patients undergoing major
surgery is a daily challenge for most clinical anaesthetists.
Continuous thoracic epidural analgesia with a low-dose
LAopioid combination has the potential to provide effective dynamic pain relief for many patients, even those
undergoing major upper abdominal or thoracic procedures.
This level of pain relief is central to early mobilization and
rapid rehabilitation. However, in the hurly-burly of a busy
surgical ward, it is not uncommon for epidurals to be
ineffective in terms of providing dynamic pain relief.
Rarely, and catastrophically, major damage to the patient
may occur.
The major factors to be considered in the safe and
effective management of ward-based epidural analgesia are
shown in Table 6.
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British Journal of Anaesthesia 87 (1): 4761 (2001)

Safety and efcacy of postoperative epidural analgesia

Effective analgesia for postoperative pain relief after major

effects and high levels of patient satisfaction. It would

Fentanyl infusion 100 mg h1

Fentanyl infusion 1 mg kg1 h1

i.v. PCA morphine

i.v. PCA morphine

Fentanyl PCEA 20 mg bolus

I.v. PCA fentanyl

Reduced fentanyl consumption

Alfentanil PCEA 250 mg bolus

i.v. alfentanil PCA

Reduced alfentanil consumption

Sufentanil infusion 0.2 mg kg1 h1

NS difference in opioid dose

Fentanyl PCEA 20 mg bolus

I.v. PCA morphine

nociceptive input but do not cause motor or sympathetic