CENTRAL NEURAXIAL BLOCKADE: MAJOR COMPLICATIONS Third National Audit project of the Royal College of Anaesthetists

2009 Dr Gareth Symons

Major Complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Cook, T.M. Counsell ,D. British Journal of Anaesthesia 102 (2): 179-90 (January 2009)

Context - ?Benefits
Masters (2002) Vets Affairs Epidural RCT (2001) Epidural & Survival (wijeysundera 2009)

Aims
To prospectively evaluate the number of CNB

procedures performed each year within the NHS system in the UK To assess the number of serious complications resulting from those procedures

Study Design
Prospective Multi-Centre National Audit within NHS Multi-disciplinary involvement Data collection over 12 month period

Methods - Denominator
Every NHS Hospital performing surgery was

enrolled in the study A local reporter (LR) was appointed at each hospital 2 weeks of data collection Blocks included were epidurals, spinals, Combined spinal-epidurals (CSEs) and caudals

Methods - Denominator
LR classified their datas accuracy Data regarding attempted then abandoned

CNB procedures was not sought 2 weeks of CNB procedures multiplied by 25

Methods Numerator Events

Spinal Infections Spinal bleeding Major nerve damage Wrong route injection errors Death where the anaesthetic/analgesic

procedure is implicated as causal

Methods - Numerator
The LR was responsible for ensuring

reporting of events but reports were accepted from all hospital staff and neurologists, neurosurgeons, radiologists and neuroradiologists were deliberately involved Cases were reviewed by a panel including representatives from the specialties involved

Methods - Interpretation
Diagnosis if this was not clear cases were

included Causation Results were analysed under two sets of assumptions, one optimistic and the other pessimistic. If causation was considered certain, likely, possible or unlikely cases were included in the pessimistic analysis. Cases considered unlikely were excluded from the optimistic analysis

Methods - Interpretation
Follow up was arranged for 6 months post

any event but if this data was not available the worst result was assumed (ie the patients symptoms did not improve)

Methods - validation
Relevant bodies were consulted to ensure

that major complications of CNB were not missed. NHS Litigation Authority National Reporting & Learning Service The Medical Protection Society The Medical Defence Union Medical Journals Google was consulted

Methods-Endpoints
NPSA severity of outcome scale None - no harm Low - Minimal harm Moderate* - Significant but not permanent

harm, or moderate increase in treatment Severe - Permanent harm due to the incident Death - Death due to the incident

* Return to surgery, unplanned re-admission, prolonged episode of care or transfer to ICU

Methods Endpoints
The primary end points of the study were the

incidences of permanent harm due to complications of the various types of CNB performed within the 1 yr audit period in an NHS hospital. The incidence of decompressive laminectomy in adult patients undergoing a perioperative epidural block was also calculated.

Results
All hospitals reported their denominator data 92% of LRs graded their data accurate 707,425 CNB procedures were performed in

the study year (extrapolated)

Results
Breakdown of CNB procedures: 46% Spinals 41% Epidurals 6% CSEs 7% Caudals The majority of CNBs were for obstetric

(45%) or perioperative care (44%)

Results - Events
108 cases reported Review of other databases revealed 1 case

which met inclusion criteria and this was subsequently reported. 56 cases were either minor and irrelevant complications of CNB or did not meet the inclusion criteria Of the 52 eligible event patients, 22 made a complete recovery from their serious complication

Results Recovered patients

7 epidural abscesses 3 meningitis 1 Vertebral Canal Haematoma 7 Nerve injury 3 Cardiovascular collapse* 1 respiratory arrest a/w intrathecal opioid

*Requiring either CPR or ICU Admission

Results - Analysis
The remaining 30 patients were included in

the pessimistic analysis Under further review, 16 patients in this group were thought likely to make a good recovery or the complication was thought to be tenuously linked to the CNB, this left 14 events to be considered in the optimistic analysis

Results Key Endpoints

Death or serious injury :

4.2 per 100,000 CNBs (CI 2.9 6.1) Deaths: 0.8 per 100,000 CNBs (CI 0 1.8)

Results
Decompressive laminectomy: 12.3/100,000 patients (perioperative epidural)

Results Permanent Harm

Perioperative 8 per 100,000 Chronic Pain 2.5 per 100,000 Obstetric 1.2 per 100,000 Paediatric 0 per 100,000 Non-anaesthetists 0 per 100,000

Results Permanent Harm

CSE 9.6 per 100,000 (CI 2.6 24.5) Epidural 6.1 per 100,000 (CI 3.6 9.7) Spinal 2.2 per 100,000 (CI 1.0 2.4) Caudal 2.1 per 100,000 (CI 1.0 11.7)

Results Severe Injury or Death

Epidural Abscess 8 patients Vertebral Canal Haematoma 5 patients Nerve injury 7 patients Spinal Cord Ischaemia 4 patients Wrong route error* 1 patient Cardiovascular collapse 3 patients Miscellaneous 2 patients

Results Deaths
6 deaths total resulting from CNB* 2 abscesses 3 cardiovascular collapses 1 IV bupivicaine injection

3 deaths recorded under optimistic interpretation

Prognosis after Injury

Ischaemia - 5/5 no or minimal improvement Abscess - 7/12 major improvement Nerve injury - 9/13 major improvement Meningitis - 3/3 major improvement Vertebral canal haematoma 6/8 major

improvment Total 25/41 major improvement

Implications
Informed consent ?Incidence of less serious complications Risk/benefit of CNB