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Development of a Development of a Registry of Regional Registry of Regional
Anaesthesia - the Anaesthesia - the AURORA studyAURORA study
St Vincent’s Hospital, MelbourneSt Vincent’s Hospital, Melbourne
Dr Michael BarringtonDr Michael BarringtonSt Vincent’s Hospital, MelbourneSt Vincent’s Hospital, Melbourne
OverviewOverview
Registries as tools of evidenced Registries as tools of evidenced based medicinebased medicine
AURORA Results June 1st 2008 -AURORA Results June 1st 2008 -January 31st 2011January 31st 2011
Experience in development of Experience in development of AURORAAURORA
Future directionFuture direction
RegistriesRegistries
Systematically and Systematically and uniformly collect uniformly collect
information from people information from people who undergo a procedure, who undergo a procedure,
are diagnosed with a are diagnosed with a disease or use a health disease or use a health
care resourcecare resource
““The term clinical registry is defined here as The term clinical registry is defined here as an observational database where there are:an observational database where there are:
1.No registry-mandated approaches to 1.No registry-mandated approaches to therapy therapy 2. Relatively few inclusion or exclusion 2. Relatively few inclusion or exclusion criteria” criteria”
““The focus of clinical registries is to The focus of clinical registries is to capture real-world clinical practice in capture real-world clinical practice in
large patient populations”large patient populations”
Monitoring what we do and Monitoring what we do and measuring our results and measuring our results and
what happens to our what happens to our patients are essential for patients are essential for
improvement in the quality improvement in the quality of careof care
Do we Do we (anaesthesiology) need (anaesthesiology) need
registries of clinical registries of clinical care?care?
““There are widespread gaps in our There are widespread gaps in our ability to rigorously define best ability to rigorously define best
practices. An astonishing number of practices. An astonishing number of recommended practices are based recommended practices are based
on expert consensus”on expert consensus”
““We lack a precise and accurate portrayal of We lack a precise and accurate portrayal of the clinical spectrum of LAST and its optimal the clinical spectrum of LAST and its optimal
treatment. This deficiency begs the treatment. This deficiency begs the development of a prospective data collection development of a prospective data collection tool in the form of a robust, comprehensive tool in the form of a robust, comprehensive
registry of LAST events designed to avoid the registry of LAST events designed to avoid the many shortcomings of a retrospective many shortcomings of a retrospective
literature reviewliterature review””
AuAustralian and New stralian and New Zealand Zealand RRegistry egistry oof f RRegional egional AAnaesthesia naesthesia
(AURORA)(AURORA)
Hospitals involved in Hospitals involved in 20102010The AlfredThe Alfred
BendigoBendigo
BallaratBallarat
GeelongGeelong
Gold CoastGold Coast
LismoreLismore
Royal North Shore Royal North Shore HospitalHospital
SheppartonShepparton
St Vincent’s HospitalSt Vincent’s Hospital
Sir Charles GairdnerSir Charles Gairdner
University of Malaya University of Malaya Medical CentreMedical Centre
WellingtonWellington
WaikatoWaikato
Hospitals involved in Hospitals involved in 20102010The AlfredThe Alfred
BendigoBendigo
BallaratBallarat
GeelongGeelong
Gold CoastGold Coast
LismoreLismore
Royal North Shore Royal North Shore HospitalHospital
SheppartonShepparton
St Vincent’s HospitalSt Vincent’s Hospital
Sir Charles GairdnerSir Charles Gairdner
University of Malaya University of Malaya Medical CentreMedical Centre
WellingtonWellington
WaikatoWaikato
AURORAAURORAcurrently supported by a ANZCA Research currently supported by a ANZCA Research
grant grant
AURORA June1st 2008 to January 31st 2011AURORA June1st 2008 to January 31st 2011
PatientPatients ns n
PNB PNB nn
F/MF/M %%
AgeAge WeightWeightASAASA
(I/II/III/IV), (I/II/III/IV), %%
10, 46110, 461 13, 13, 648648
49/549/511
58 ±19 80 ± 19 20/39/36/5
AuAustralian and New stralian and New Zealand Zealand RRegistry egistry oof f RRegional egional AAnaesthesia naesthesia
(AURORA)(AURORA)
AURORA, June1st 2008 to January 31st 2011AURORA, June1st 2008 to January 31st 2011
80% of peripheral 80% of peripheral nerve blockade (PNB)nerve blockade (PNB)
US or US + NSUS or US + NS
AuAustralian and New stralian and New Zealand Zealand RRegistry egistry oof f RRegional egional AAnaesthesia naesthesia
(AURORA)(AURORA)Local anaesthetic toxicityLocal anaesthetic toxicity
IncidenceIncidence
PeriodPeriod 2006 - 2006 - 20082008 2008 - 20112008 - 2011
n:1000 n:1000 (95% CI)(95% CI)
0.980.98(0.42 - 1.9)(0.42 - 1.9)
0.40.4(0.2 - 1.0)(0.2 - 1.0)
Local anaesthetic toxicityLocal anaesthetic toxicityIncidenceIncidence
PeriodPeriod 2006 - 2006 - 20082008 2008 - 20112008 - 2011
n:1000 n:1000 (95% CI)(95% CI)
0.980.98(0.42 - 1.9)(0.42 - 1.9)
0.40.4(0.2 - 1.0)(0.2 - 1.0)
2006 - 2011: Total of 14 cases LAST, 2006 - 2011: Total of 14 cases LAST, 1 case severe LAST 1 case severe LAST
20, 000 PNB20, 000 PNB
Local anaesthetic toxicityLocal anaesthetic toxicityIncidenceIncidence
PeriodPeriod 2006 - 2006 - 20082008 2008 - 20112008 - 2011
n:1000 n:1000 (95% CI)(95% CI)
0.980.98(0.42 - 1.9)(0.42 - 1.9)
0.40.4(0.2 - 1.0)(0.2 - 1.0)
2008 - 2011, ropivacaine 78% PNB,2008 - 2011, ropivacaine 78% PNB, 1.7 ± 0.9 mg/kg
Local Anaesthetic Systemic Toxicity (LAST)
AURORA, June1st 2008 to January 31st 2011AURORA, June1st 2008 to January 31st 2011
Nerve localization techniqueNerve localization technique(results expressed as n:1000 (95% CI)(results expressed as n:1000 (95% CI)
ComplicationComplication Nerve Nerve stimulationstimulation UltrasoundUltrasound TotalTotal
Late Late neurological neurological
deficitdeficit
0.80.8(0.1 - 2.9) (0.1 - 2.9)
0.20.2(0.05 - 1.1)(0.05 - 1.1)
0.40.4(0.08 - 1.1)(0.08 - 1.1)
the risk of nerve damage is 0.4: 1000the risk of nerve damage is 0.4: 1000Definitions: Definitions:
http://www.regional.anaesthesia.org.au/def_delayedfu.htmlhttp://www.regional.anaesthesia.org.au/def_delayedfu.html
%US
% NS
Ultrasound guidance has not Ultrasound guidance has not reduced nerve injury? reduced nerve injury?
Ultrasound guidance Ultrasound guidance has not reduced nerve has not reduced nerve injury? and ?injury? and ?
ExpectationsExpectations
TechnologyTechnology
Rarity of the eventRarity of the event
Limitation of study designLimitation of study design
Nature of the outcomeNature of the outcome
Clinical registriesClinical registriesComplete inclusion of all eligible Complete inclusion of all eligible patientspatients
Capture ALL episodes of peripheral Capture ALL episodes of peripheral regional anaesthesia performed by ALL regional anaesthesia performed by ALL practitioners on ALL patientspractitioners on ALL patients
Reduce selection biasReduce selection bias
Business as usualBusiness as usual
No cherry pickingNo cherry picking
Include good and bad outcomesInclude good and bad outcomes
ProcessProcess
Regular communicationRegular communication
Train data collectorsTrain data collectors
Online interfaceOnline interface
Followup definedFollowup defined
Outcomes are definedOutcomes 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; 51:305-315
Important featureImportant feature
Systematic postoperative contact with Systematic postoperative contact with all patientsall patients
Investigation of all potential Investigation of all potential neurological deficitsneurological deficits
Allows separation of PNB-related Allows separation of PNB-related deficits from those unrelated to PNBdeficits from those unrelated to PNB
Results of neurological Results of neurological evaluation (2006 -08)evaluation (2006 -08)
AuAustralian and New stralian and New Zealand Zealand RRegistry egistry oof f RRegional egional AAnaesthesia naesthesia
(AURORA)(AURORA)Late neurological deficitLate neurological deficit
PeriodPeriod 2006 - 2006 - 20082008 2008 - 20112008 - 2011
n:1000 n:1000 (95% CI)(95% CI)
0.40.4(0.08 - (0.08 -
1.1)1.1)
0.40.4(0.2 - 1.0)(0.2 - 1.0)
ComplicationsComplications
OutcomeOutcome nn
2008 - 2008 - 20112011
n:1000 (95% n:1000 (95% CI)CI)
CommentComment
LASTLAST 660.40.4
(0.2 - 1.0)(0.2 - 1.0) Mild in severityMild in severity
Cardiac arrestCardiac arrest 110.070.07
(0.002 - (0.002 - 0.4)0.4)
Paravertebral Paravertebral blockblock
Late Late neurologicalneurological
deficit deficit 66
0.40.4(0.2 - 1.0)(0.2 - 1.0)
5/6 5/6 comorbiditiescomorbidities
ComplicationsComplications
OutcomeOutcome nn
2008 - 2008 - 20112011
n:1000 (95% n:1000 (95% CI)CI)
CommentComment
Wrong-site Wrong-site PNBPNB 44
0.30.3(0.08 - 0.8)(0.08 - 0.8)
Lower limb, Lower limb, languagelanguage
Respiratory Respiratory depressiondepression 33
0.20.2(0.05 - 0.6)(0.05 - 0.6)
Phrenic nerve Phrenic nerve paralysis (2)paralysis (2)
Neuraxial spread Neuraxial spread (1)(1)
ComplicationsComplications n:1000 (95% CI)n:1000 (95% CI)
OutcomeOutcome 2008 - 20112008 - 2011 CommentComment
PneumothoraPneumothoraxx
0.90.9(0.1 - 3.9)(0.1 - 3.9)
Infraclavicular Infraclavicular block (1)block (1)
Supraclavicular Supraclavicular block (1)block (1)
TrainingTrainingLearn sonography skills on patients Learn sonography skills on patients (independant of invasive procedures)(independant of invasive procedures)
Core skillCore skill
Learn needling skills (principles) Learn needling skills (principles) before performing blocksbefore performing blocks
Pre-procedural trainingPre-procedural training
Procedure specificProcedure specific
Use of phantoms is evidenced-basedUse of phantoms is evidenced-based
n = 3056 n = 3505 n = 4710 n = 6609
20072008
20092010
%
The FutureThe Future
New databaseNew database
www.anaesthesiaregistry.org
FutureFuture
Patient-rated outcomesPatient-rated outcomes
Rotating data setsRotating data sets
Develop research infrastructureDevelop research infrastructure
Widen analytical techniquesWiden analytical techniques
CollaborationCollaboration
interdisciplinaryinterdisciplinary
epidemiologistsepidemiologists
In conclusion - registriesIn conclusion - registries
Are valid tools of evidenced based Are valid tools of evidenced based medicinemedicine
Measure and report outcomes from Measure and report outcomes from routine practiceroutine practice
Much of what we do and what happens Much of what we do and what happens to our patients is not documented or to our patients is not documented or reported - health care issuereported - health care issue
Improve the quality and safety of care Improve the quality and safety of care
In conclusion - AURORAIn conclusion - AURORA
Serious complications of PNB are Serious complications of PNB are infrequentinfrequent
Neurologic outcomes complexNeurologic outcomes complex
Serious LAST rare in our practiceSerious LAST rare in our practice
Wrong-site avoidableWrong-site avoidable
Debate role of supraclavicular blockDebate role of supraclavicular block
Training needs to be improved - workplaceTraining needs to be improved - workplace
Thank you for your Thank you for your attentionattention