Papers
Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials
Anthony Rodgers a Clinical Trials Research Unit, Department of
Medicine, University of Auckland, Private Bag 92019, Auckland, New
Zealand, b Division of Anaesthesiology, University of Auckland, c Department of Anaesthetics, Green
Lane Hospital, Epsom, Auckland 1003, New Zealand, d Department of
Surgical Gastroenterology, Hvidovre University Hospital, DK-2650
Hvidovre, Denmark, e Department of Anesthesiology, Intensive Care and Pain Therapy,
Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, Netherlands, f Department of Anaesthesia,
Auckland and Starship Hospitals, Private Bag 92024, Auckland, New
Zealand, g Department of
Anaesthesia, Royal Cornwall Hospital, Treliske, Truro TR1 3LJ, h Institute
for International Health, University of Sydney, PO Box 1225, Crows
Nest, Sydney, NSW 1585, Australia
Correspondence to: A Rodgers
a.rodgers{at}ctru.auckland.ac.nz
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Abstract |
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 Abstract
 Introduction
Methods
Results
Discussion
References
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Objectives:
To obtain reliable estimates of the
effects of neuraxial blockade with epidural or spinal anaesthesia on
postoperative morbidity and mortality.
Anaesthesia is commonly classified into two main techniques:
general anaesthesia, in which gaseous or intravenous drugs achieve central neurological depression, and regional anaesthesia, in which
drugs are administered directly to the spinal cord or nerves to locally
block afferent and efferent nerve input.1 Regional anaesthesia for major thoracic, abdominal, or leg surgery relies on
neuraxial blockade by injection of local anaesthetic drugs into either
the subarachnoid space (spinal anaesthesia) or into the epidural space
surrounding the spinal fluid sac (epidural anaesthesia).
The risks of fatal or life threatening events are increased several
fold after major surgery, but there is debate about whether the type of
anaesthesia has any substantive effect on these risks. Neuraxial
blockade has several physiological effects that provide a rationale for
expecting to improve outcome with this technique.2 However, the few clinical trials of epidural or spinal anaesthesia that
have focused specifically on fatal or life threatening events have
generally been too small to detect effects of plausible size reliably.
To provide more reliable estimates of the effects of neuraxial blockade
on postoperative morbidity and mortality, we conducted a
systematic review of all relevant randomised trials.
Identification of trials and data collection
Design:
Systematic review of all trials with
randomisation to intraoperative neuraxial blockade or not.
Studies:
141 trials including 9559 patients for which data were available before 1 January 1997. Trials were eligible irrespective of their primary aims, concomitant use of general anaesthesia, publication status, or language. Trials were identified by
extensive search methods, and substantial amounts of data were obtained
or confirmed by correspondence with trialists.
Main outcome measures:
All cause mortality, deep
vein thrombosis, pulmonary embolism, myocardial infarction, transfusion
requirements, pneumonia, other infections, respiratory depression, and
renal failure.
Results:
Overall mortality was reduced by about a
third in patients allocated to neuraxial blockade (103 deaths/4871
patients versus 144/4688 patients, odds ratio=0.70, 95% confidence
interval 0.54 to 0.90, P=0.006). Neuraxial blockade reduced the odds of deep vein thrombosis by 44%, pulmonary embolism by 55%, transfusion requirements by 50%, pneumonia by 39%, and respiratory depression by
59% (all P<0.001). There were also reductions in myocardial infarction and renal failure. Although there was limited power to
assess subgroup effects, the proportional reductions in mortality did
not clearly differ by surgical group, type of blockade (epidural or
spinal), or in those trials in which neuraxial blockade was combined
with general anaesthesia compared with trials in which neuraxial
blockade was used alone.
Conclusions:
Neuraxial blockade reduces postoperative
mortality and other serious complications. The size of some of these
benefits remains uncertain, and further research is required to
determine whether these effects are due solely to benefits of neuraxial blockade or partly to avoidance of general anaesthesia. Nevertheless, these findings support more widespread use of neuraxial blockade.
Introduction
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Abstract
Introduction
Methods
Results
Discussion
References
Methods
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Abstract
Introduction
Methods
Results
Discussion
References
We sought to identify all trials in which patients were randomised
to receive intraoperative neuraxial blockade (with epidural or spinal
anaesthesia) or not. We did not exclude trials in adult populations in
which the group receiving neuraxial blockade group also received
general anaesthesia, the general anaesthesia group received
postoperative neuraxial blockade, or there was more than one type of
neuraxial blockade or general anaesthesia group (in which case similar
groups were combined). Eligibility was not based on whether results
were published, the language of publication, or the primary aims of the
trial 
for example, we included a randomised trial designed
to assess the effects of neuraxial blockade on cognitive
function.3 Trials were ineligible if they were not
randomised or were quasi-randomised (such as assignment according to
date of birth) or if data were not available before 1 January 1997.
Statistical analysis
Analysis was carried out on an intention to treat basis wherever
possible. If no events were reported in the publication or by the
authors, we assumed that none occurred. This assumption will generally
provide unbiased estimates of proportional effects (the entity
typically combined in meta-analysis) but will underestimate absolute
effects.6 We calculated odds ratios, 95% confidence
intervals, and two sided P values for each outcome of interest using
Peto's modification of the Mantel-Haenszel method.7 Homogeneity was assessed by a 
2 test. Whenever
possible, we stratified analyses of cause specific outcomes by surgical
group and type of anaesthetic to determine whether these factors
modified the size or direction of proportional effects. However, there
were often too few trials with events for such analyses to be
informative, and so subgroup analyses are mostly reported for the crude
outcome of total mortality.
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Results |
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Abstract
Introduction
Methods
Results
Discussion
References
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Study characteristics
We identified 158 potentially eligible trials. Ten studies
were excluded because they were quasi-randomised,8-17 and
six were excluded because not all participants were randomised and
separate information on the randomised patients was not
available.18-23 One trial was excluded because the groups
differed with respect to heparin treatment as well as anaesthetic
technique.24 The remaining 141 trials that met all the
inclusion criteria included a total of 9559 patients.
3 25-192
More than one publication was available
for 18 studies
46-49 59 60 62-65 72 73 84 85
87-92 94-96 99 100 106 107 124-128 134 135 145 146 156-158 161-163 173 174 187 188
but each study was counted only once. No unpublished eligible studies
were identified.
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Overall mortality
A total of 247 deaths within 30 days of randomisation were
recorded in 35 trials. Overall mortality was about one third less in
the neuraxial blockade group (odds ratio 0.70, 95% confidence interval
0.54 to 0.90, P=0.006; fig 1) with no clear difference between
different surgical groups (fig 2). A specific diagnosis was available
for 162 of the deaths. Of these, 73 (45%) were due to pulmonary
embolism, cardiac events, or stroke, 50 (31%) were due to infective
causes, and 39 (24%) were due to other causes. The observed
improvement in survival was due to trends towards reductions in deaths
from pulmonary embolism, cardiac events, or stroke (0.73, 0.45 to
1.16), deaths from infection (0.68, 0.39 to 1.21), deaths from other
causes (0.84, 0.44 to 1.61), and deaths from unknown causes (0.64, 0.41 to 1.01). There was about one fewer death per 100 patients in the 30 days after randomisation in the neuraxial blockade group (103/4871
(2.1%) versus 144/4688 (3.1%)). Only six intraoperative deaths were
recorded, one of which was in the neuraxial blockade group (0.28, 0.06 to 1.45). Ten studies, with a total of 1371 patients, recorded 130 deaths between 30 days and six months. All but two of these studies
were on orthopaedic patients. Overall, there was no clear effect of neuraxial blockade on deaths during this period (0.89, 0.61 to 1.28).
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Mortality results by type of anaesthesia
Seven trials (with 826 participants) directly randomised patients
to spinal or epidural
anaesthesia.
25 32 77 104 153 181
Only 13 deaths
occurred in these trials, four in the spinal group. However, an
indirect comparison between trials of spinal and epidural anaesthesia
showed no clear difference between their effects on total mortality
(0.68, 0.49 to 0.95 for spinal anaesthesia and 0.68, 0.43 to 1.07 for
epidural anaesthesia, P for homogeneity=1.0; fig 2). Mortality was
reduced overall whether neuraxial blockade was continued
postoperatively (0.68, 0.43 to 1.08) or not (0.70, 0.51 to 0.97). The
effect on total mortality was not clearly lower in trials in which
neuraxial blockade was combined with general anaesthesia (0.87, 0.53 to
1.41) than in trials in which neuraxial blockade was used alone (0.64, 0.47 to 0.87; P for homogeneity=0.3; fig 2). However, the confidence
intervals were wide for the trials that used general anaesthesia. Forty
four (18%) deaths occurred in the 22 trials in which the neuraxial
blockade group had a different general anaesthesia to that used in the
group not allocated neuraxial blockade. The overall effect in this
group of trials (0.92, 0.49 to 1.71) was not clearly different (P for
homogeneity=0.3) from that in other trials (0.66, 0.49 to 0.88).
Venous thromboembolism, cardiac events, and stroke
A total of 365 deep vein thromboses were reported from 18 trials.
Neuraxial blockade reduced the risk of deep vein thrombosis by almost
half (0.56, 0.43 to 0.72; fig 3). Since more than 80% of deep vein
thromboses were recorded in orthopaedic trials, there was limited power
to detect differences between surgical groups. In nine trials all
patients were screened for deep vein thromboses by fibrinogen
scanning,
59 87 129
venography,
74 114 132 187
or a combination of
methods.
62 94
Proportional reductions in deep vein
thromboses were similar in the trials with screening (0.56, 0.42 to
0.75) compared with other trials (0.54, 0.30 to 0.96). Therefore,
absolute differences were much greater in the trials with screening
(121/463 (26%) for neuraxial blockade versus 178/467 (38%) for no
neuroaxial blockade) than in other trials (24/4408 (0.5%) versus
42/4221 (1.0%)). Outcome assessments were known to be blinded in only
two trials, and deep vein thromboses were also reduced in these studies
(0.46, 0.21 to 0.99).
66 98
A total of 96 pulmonary emboli
were reported from 23 trials, 21 (22%) of which were fatal. Overall,
there were about half as many pulmonary emboli in patients allocated to
neuraxial blockade (0.45, 0.29 to 0.69; fig 3).
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Bleeding
In total, 473 patients from 16 trials required transfusion of two
or more units of blood and 100 patients from 12 trials had a
postoperative bleed requiring a transfusion. The requirement for a
transfusion of two or more units of blood was reduced by about half in
patients allocated neuraxial blockade (0.50, 0.39 to 0.66; fig 3). A
similar proportional reduction was found for postoperative bleeds
requiring a transfusion (0.45, 0.29 to 0.70; fig 3). There was no clear
difference in the proportional effects on either outcome across
surgical groups.
Postoperative infection
In total, 62 wound infections were reported from 14 trials. There
were fewer wound infections in those allocated to neuraxial blockade,
although the confidence intervals were wide (0.79, 0.47 to 1.33; fig
3). Three hundred and eighty seven cases of pneumonia were recorded in
28 trials, of which 38 (10%) were fatal. The risk of developing
pneumonia was less in patients randomised to neuraxial blockade (0.61, 0.48 to 0.76; fig 3). There was no clear difference in the proportional
effects with the use of concomitant general anaesthesia (neuraxial
blockade versus general anaesthesia: 0.63, 0.46 to 0.87; neuraxial
blockade plus general anaesthesia versus general anaesthesia: 0.59, 0.42 to 0.81). However, there was some evidence (P for
homogeneity=0.05) that the proportional reduction in pneumonia was
greater after thoracic epidural anaesthesia (0.48, 0.35 to 0.67) than
after lumbar epidural or spinal anaesthesia (0.76, 0.55 to 1.04).
Twelve deaths due to an infective cause other than pneumonia were
recorded in six trials, of which two occurred in patients allocated to neuraxial blockade (0.33, 0.10 to 1.07; fig 3).
Other postoperative events
A total of 64 cases of respiratory depression were reported from
eight trials. The odds of respiratory depression were reduced by 59%
in patients allocated to neuraxial blockade (0.41, 0.23 to 0.73; fig
3). The effect was present in trials with and without concomitant
general anaesthesia (neuraxial blockade alone versus general
anaesthesia 0.37, 0.11 to 1.21; neuraxial blockade plus general
anaesthesia versus general anaesthesia 0.43, 0.22 to 0.81). Fifty cases
of renal failure were recorded in 10 trials. Although the risk of renal
failure was reduced in patients randomised to neuraxial blockade, the
confidence intervals were wide and compatible with both no effect and a
two thirds reduction (0.57, 0.32 to 1.00; fig 3).
Sensitivity analyses
We conducted several analyses to assess whether the effects on
total mortality were dependent on trials with methodological problems
or affected by the type of anaesthesia. However, all these tests lacked
power to detect moderate sized differences.
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Discussion |
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Abstract
Introduction
Methods
Results
Discussion
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Our overview shows improved survival in patients randomised to neuraxial blockade. Additionally, we found reductions in risk of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression, and renal failure. There was no clear evidence that these effects, in proportional terms, differed by the type of surgical group or the type of neuraxial blockade, although there was limited power to assess subgroup effects reliably. Furthermore, there was no evidence of "catch up" mortality in the neuraxial blockade group between 30 days and 6 months.
The benefits seen for neuraxial blockade may be conferred by multifactorial mechanisms, including altered coagulation, increased blood flow, improved ability to breathe free of pain, and reduction in surgical stress responses.2 In particular, major surgery induces a "stress response" that is substantially altered by neuraxial blockade but not by general anaesthesia.2 This observation, together with the subgroup comparisons shown here, suggests that these benefits are principally due to the use of neuraxial blockade rather than avoidance of general anaesthesia. Thus the key issue seems to be whether neuraxial blockade is used or not, and the way in which this is achieved is less relevant.
Validity of findings
It is unlikely that bias could explain much of the reduction in
mortality. We included all randomised trials, irrespective of their
initial aims or reported findings. Most trials were not designed to
assess major events, but it is unlikely that we missed many deaths or
major non-fatal events because we contacted the authors of trials
involving 87% of patients and few patients had no outcome data.
However, incidence will have been underestimated for non-fatal events
that often go undiagnosed, such as deep vein thrombosis. This finding
will not bias relative risk estimates6 unless information
is selectively available from trials with extreme results. For deep
vein thrombosis, at least, the proportional effect of neuraxial
blockade in trials designed to assess this outcome was similar to that
in other trials. With regard to other potential biases, lack of
blinding may have caused some selective misdiagnosis of non-fatal
events, but analyses did not indicate publication bias and the overall
reduction in mortality was not dependent on inclusion of trials with
unconfirmed data or trials for which intention to treat analyses were
not possible. Lastly, even though these data represent most of the randomised evidence potentially available, the confidence intervals were wide for many outcomes and relatively little information was
available about cause of death.
Implications
Our overview indicates that neuraxial blockade reduces major
postoperative complications in a wide range of patients. However,
uncertainty about the net benefits of neuraxial blockade is likely to
remain among some clinicians and for some patient groups. For example,
opinion is divided about whether neuraxial blockade is indicated or
contraindicated in patients at risk of cardiac
complications,197 and it is unclear whether the
differences that we observed reflect the benefits of neuraxial blockade
alone or are partly due to the avoidance of the adverse effects of
general anaesthesia. Such uncertainties provide the rationale for large randomised trials, such as the ongoing multicentre Australian study of
epidural anaesthesia and analgesia in major surgery.198 However, since serious complications associated with neuraxial blockade, such as spinal haematoma, are very rare199-201
and more common side effects, such as headache or urinary retention,
are not life threatening, our data support recent trends towards
increased use of neuraxial blockade. Furthermore, although we focused
on intraoperative anaesthetic techniques, postoperative neuraxial blockade has been shown to have additional benefits, at least for
pulmonary complications.202 Overall, therefore our data
should result in more widespread use of spinal or epidural anaesthesia.
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What is already known on this topic
Neuraxial blockade with epidural or spinal anaesthesia reduces the incidence of deep vein thrombosis and one month mortality in hip fracture patients Insufficient evidence exists for other postoperative outcomes in this surgical group What this study addsMortality was reduced by one third in patients allocated neuraxial blockade Reductions in mortality did not differ by surgical group, type of blockade, or in trials in which neuraxial blockade was combined with general anaesthesia Neuraxial blockade also reduced the risk of deep vein thrombosis, pulmonary embolism, transfusion requirements, pneumonia, respiratory depression, myocardial infarction, and renal failure |
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Acknowledgments |
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We thank all trialists who confirmed data and provided extra information for this overview: T K Abboud, A R Aitkenhead, T Asoh, J F Baron, A Bayer, D Berggren, P Berthelsen, D Bigler, P K Bithal, W P Blunnie, R Bode, F Bonnet, N A Borovskikh, M R Brandt, S Bredbacka, M J Breslow, F P Buckley, K S Channer, S P Chin, R Christopherson, F Chung, E Couderc, R J Cuschieri, J B Dahl, F M Davies, M J Davies, M Davis, M De Kock, J Devulder, W Dick, N D Edwards, S M Frank, R L Garnett, S Gelman, S P Gerrish, M M Ghoneim, M S Gold, A Gottlieb, E Hakansson, M Hasenbos, H Hendolin, S W Henneberg, A Holdcroft, A Hole, R Hosoda, P L Houweling, A O Hughes, C Jayr, J Jenkins, N Jia, R D M Jones, L N Jorgensen, J Kanto, H Kehlet, A Lehtinen, M Licker, R A M Mann, P Maurette, S McGowan, P J McKenzie, A D McLaren, G Mellbring, N Melsen, I Milsom, J Modig, S Moiniche, I Murat, J M Murray, J A Odoom, M S J Pathy, J Pedersen, J S Poll, A V Pollock, J P Racle, S Raja, K Reinhart, H Renck, B Rosberg, B A Rosenfeld, H Rutberg, P Ryan, B Scheinin, W Seeling, N Sharrock, I Smilov, T Stathopoulou, R Stenseth, V I Strashnov, J Takala, J Takeda, M V Tseshinsky, H Tsuji, K J Tuman, N Valentin, J M Watters, L G Welborn, A Wessen, I W C White, C Wiessman, P Williams-Russo, M P Yeager, and O N Zabrodin. We thank Iain Chalmers, Rory Collins, Mike Davis, Konrad Jamrozik, John McCall, Tom Pedersen, John Rigg, and Charles Warlow for their helpful comments and Gary Whitlock, Xin-Hua Zhang, Philippa Day, and Valentine Kravtsov for help with translating papers.
Contributors: AR had the original idea for this study. All authors contributed actively to the protocol. NW and AR performed all searching for trials and AM, SS, and GS abstracted the data. NW and TC carried out all data analysis. AR, NW, AM, TC, and SS wrote the first draft of the paper and HK, AvZ, DS, MF, and SM made revisions. AR will act as guarantor for the paper.
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Footnotes |
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Funding: Health Research Council of New Zealand and Astra Pain, New Zealand. NW undertook this research during the tenure of a training fellowship from the Health Research Council of New Zealand. AR is a senior research fellow of the National Heart Foundation of New Zealand.
Competing interests: HK has received fees for consulting and speaking at meetings from AstraZeneca.
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References |
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Introduction
Methods
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References
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(Accepted 4 September 2000)
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Rapid Responses:
Read all Rapid Responses
- Should we target our regional anaesthetics ?
- J C Hughes
bmj.com, 18 Dec 2000 [Full text] - Possible Toxicity of General Anaesthesia
- Stephen Barratt
bmj.com, 19 Dec 2000 [Full text] - Outcome benefits from epidural anaesthesia: true for all surgical groups?
- R Jonathan T Wilson
bmj.com, 20 Dec 2000 [Full text] - Odds ratios are best displayed on a logarithmic scale
- Sally Hollis
bmj.com, 10 Jan 2001 [Full text] - Accurate summary or misleading statement?
- Andrew Norris
bmj.com, 12 Jan 2001 [Full text] - Re: Control for confounding factors
- Johann Harten
bmj.com, 12 Jan 2001 [Full text] - Number needed to treat derived from a meta-analysis may be misleading
- Markku Hynynen
bmj.com, 18 Jan 2001 [Full text] - Comparing Apples with Fruit Salad?
- Timothy James McCulloch
bmj.com, 19 Jan 2001 [Full text] - Regional or general anaesthesia: is the question answered?
- Helen Higham
bmj.com, 19 Jan 2001 [Full text] - Comment to Rodgers et al, BMJ 2000;321:1493
- K D Stuhmeier
bmj.com, 14 Feb 2001 [Full text]
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