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 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 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 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” “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 The Alfred Bendigo Bendigo Ballarat Ballarat Geelong Geelong Gold Coast Gold Coast Lismore Lismore Royal North Shore Hospital Royal North Shore HospitalShepparton St Vincent’s Hospital Sir Charles Gairdner University of Malaya Medical Centre WellingtonWaikato

Hospitals involved in 2010 The Alfred The Alfred Bendigo Bendigo Ballarat Ballarat Geelong Geelong Gold Coast Gold Coast Lismore Lismore Royal North Shore Hospital Royal North Shore HospitalShepparton St Vincent’s Hospital Sir Charles Gairdner University of Malaya Medical Centre WellingtonWaikato AURORA currently supported by a ANZCA Research grant

AURORA June1st 2008 to January 31st 2011 Patients n PNBnF/M %AgeWeightASA (I/II/III/IV), % 10, , /5158 ±1980 ± 1920/39/36/5 Australian and New Zealand Registry of Regional Anaesthesia (AURORA)

AURORA, June1st 2008 to January 31st % of peripheral nerve blockade (PNB) US or US + NS

Australian and New Zealand Registry of Regional Anaesthesia (AURORA) Local anaesthetic toxicity Incidence Period n:1000 (95% CI) 0.98 ( ) 0.4 ( )

Local anaesthetic toxicity Incidence Period n:1000 (95% CI) 0.98 ( ) 0.4 ( ) : Total of 14 cases LAST, 1 case severe LAST 20, 000 PNB

Local anaesthetic toxicity Incidence Period n:1000 (95% CI) 0.98 ( ) 0.4 ( ) , ropivacaine 78% PNB, , 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 UltrasoundTotal Late neurological deficit 0.8 ( ) 0.2 ( ) 0.4 ( ) the risk of nerve damage is 0.4: 1000 Definitions:

% US % NS Ultrasound guidance has not reduced nerve injury?

Ultrasound guidance has not reduced nerve injury? and ? ExpectationsTechnology 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; 51:

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 ( )

Australian and New Zealand Registry of Regional Anaesthesia (AURORA) Late neurological deficit Period n:1000 (95% CI) 0.4 ( ) 0.4 ( )

Complications Outcomen n:1000 (95% CI) Comment LAST60.4 ( ) Mild in severity Cardiac arrest ( ) Paravertebral block Late neurological deficit60.4 ( ) 5/6 comorbidities

Complications Outcomen n:1000 (95% CI) Comment Wrong-site PNB 40.3 ( ) Lower limb, language Respiratory depression 30.2 ( ) Phrenic nerve paralysis (2) Neuraxial spread (1)

Complications n:1000 (95% CI) Outcome Comment Pneumothorax0.9 ( ) 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

n = 3056 n = 3505n = 4710n = % The Future

New database

Future Patient-rated outcomes Rotating data sets Develop research infrastructure Widen analytical techniques Collaborationinterdisciplinaryepidemiologists

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