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