Development of a Registry of
Regional Anaesthesia - the
AURORA study
St Vincent’s Hospital, Melbourne
Dr Michael Barrington
St Vincent’s Hospital, Melbourne
Overview
Registries as tools of evidenced based
medicine
AURORA Results June 1st 2008 January 31st 2011
Experience in development of AURORA
Future direction
Registries
•
Systematically and uniformly
collect information from
people who undergo a
procedure, are diagnosed
with a disease or use a health
care resource
“The term clinical registry is defined here as an
observational database where there are:
1.No registry-mandated approaches to therapy
2. Relatively few inclusion or exclusion criteria”
“The focus of clinical registries is to capture
real-world clinical practice in large patient
populations”
Monitoring what we do and
measuring our results and
what happens to our patients
are essential for improvement
in the quality of care
Do we (anaesthesiology)
need registries of clinical
care?
“There are widespread gaps in our
ability to rigorously define best
practices. An astonishing number of
recommended practices are based on
expert consensus”
•
“We lack a precise and accurate portrayal of the
clinical spectrum of LAST and its optimal treatment.
This deficiency begs the development of a
prospective data collection tool in the form of a
robust, comprehensive registry of LAST events
designed to avoid the many shortcomings of a
retrospective literature review”
Australian and New
Zealand Registry of
Regional Anaesthesia
(AURORA)
Hospitals involved in 2010
•
The Alfred
•
Bendigo
Shepparton
•
Ballarat
St Vincent’s Hospital
•
Geelong
Sir Charles Gairdner
•
Gold Coast
University of Malaya
Medical Centre
•
Lismore
•
Royal North Shore
Hospital
Wellington
Waikato
Hospitals involved in 2010
•
The Alfred
•
Bendigo
Shepparton
•
Ballarat
St Vincent’s Hospital
•
Geelong
•
•
•
Sir
Charles
Gairdner
AURORA
currently
a ANZCAofResearch
Malaya
Gold
Coast supported by University
Medical Centre
grant
Lismore
Wellington
Royal North Shore
Waikato
Hospital
Australian and New
Zealand Registry of
Regional Anaesthesia
(AURORA)
AURORA June1st 2008 to January 31st 2011
Patients n
10, 461
PNB
n
F/M
%
13, 648 49/51
Age
Weight
ASA
(I/II/III/IV), %
58 ±19
80 ± 19
20/39/36/5
AURORA, June1st 2008 to January 31st 2011
80% of peripheral nerve
blockade (PNB)
US or US + NS
Australian and New
Zealand Registry of
Regional Anaesthesia
(AURORA)
Local anaesthetic toxicity
Incidence
Period
2006 - 2008
2008 - 2011
n:1000
(95% CI)
0.98
(0.42 - 1.9)
0.4
(0.2 - 1.0)
Local anaesthetic toxicity
Incidence
Period
2006 - 2008
2008 - 2011
n:1000
(95% CI)
0.98
(0.42 - 1.9)
0.4
(0.2 - 1.0)
2006 - 2011: Total of 14 cases LAST,
1 case severe LAST
20, 000 PNB
Local anaesthetic toxicity
Incidence
Period
2006 - 2008
2008 - 2011
n:1000
(95% CI)
0.98
(0.42 - 1.9)
0.4
(0.2 - 1.0)
2008 - 2011, ropivacaine 78% PNB, 1.7 ± 0.9 mg/kg
Local Anaesthetic Systemic
Toxicity (LAST)
AURORA, June1st 2008 to January 31st 2011
Nerve localization technique
(results expressed as n:1000 (95% CI)
Complication
Nerve
stimulation
Ultrasound
Total
Late neurological
deficit
0.8
(0.1 - 2.9)
0.2
(0.05 - 1.1)
0.4
(0.08 - 1.1)
the risk of nerve damage is 0.4: 1000
Definitions:
http://www.regional.anaesthesia.org.au/def_delayedfu.html
Ultrasound guidance has not reduced
nerve injury?
%
NS
%
US
Ultrasound guidance has
not reduced nerve injury?
and ?
Expectations
Technology
Rarity of the event
Limitation of study design
Nature of the outcome
Clinical registries
Complete inclusion of all eligible patients
Capture ALL episodes of peripheral regional
anaesthesia performed by ALL practitioners on ALL
patients
Reduce selection bias
Business as usual
No cherry picking
Include good and bad outcomes
Process
Regular communication
Train data collectors
Online interface
Followup defined
Outcomes are defined
Definition of RA related
neurologic complication
✤
New onset of sensory/motor deficit consistent with nerve/plexus
distribution area without other identifiable cause
✤
AND
✤
One of the following
✤
electrophysiologic evidence of nerve damage
✤
new neurological signs
✤
new onset of neuropathic pain in the nerve distribution
✤
paraesthesia in the affected nerve distribution area
Schulz-Stubner S, Kelly J, Regional Anesthesia Surveillance System: First Experiences with a
quality assessment tool for regional anesthesia and analgesia. Acta Anaesthesiol Scand. 2007;
Important feature
Systematic postoperative contact with all
patients
Investigation of all potential neurological
deficits
Allows separation of PNB-related deficits
from those unrelated to PNB
Results of neurological
evaluation (2006 -08)
Australian and New
Zealand Registry of
Regional Anaesthesia
(AURORA)
Late neurological deficit
Period
2006 - 2008
2008 - 2011
n:1000
(95% CI)
0.4
(0.08 - 1.1)
0.4
(0.2 - 1.0)
Complications
2008 - 2011
Outcome
LAST
Cardiac arrest
Late neurological
deficit
n
6
1
6
n:1000 (95%
CI)
0.4
(0.2 - 1.0)
Comment
Mild in severity
0.07
Paravertebral block
(0.002 - 0.4)
0.4
(0.2 - 1.0)
5/6 comorbidities
Complications
2008 - 2011
Outcome
Wrong-site PNB
Respiratory
depression
n
4
3
n:1000 (95%
CI)
Comment
0.3
(0.08 - 0.8)
Lower limb,
language
0.2
(0.05 - 0.6)
Phrenic nerve
paralysis (2)
Neuraxial spread
(1)
Complications
n:1000 (95% CI)
Outcome
Pneumothorax
2008 - 2011
0.9
(0.1 - 3.9)
Comment
Infraclavicular
block (1)
Supraclavicular
block (1)
Training
Learn sonography skills on patients
(independant of invasive procedures)
Core skill
Learn needling skills (principles) before
performing blocks
Pre-procedural training
Procedure specific
Use of phantoms is evidenced-based
The Future
n = 3056
n = 3505
n = 4710
n = 6609
%
2007
2008
2009
2010
New database
www.anaesthesiaregistry.org
Future
Patient-rated outcomes
Rotating data sets
Develop research infrastructure
Widen analytical techniques
Collaboration
interdisciplinary
epidemiologists
In conclusion - registries
Are valid tools of evidenced based medicine
Measure and report outcomes from routine
practice
Much of what we do and what happens to
our patients is not documented or reported health care issue
Improve the quality and safety of care
In conclusion - AURORA
Serious complications of PNB are
infrequent
Neurologic outcomes complex
Serious LAST rare in our practice
Wrong-site avoidable
Debate role of supraclavicular block
Training needs to be improved - workplace
Thank you for your
attention