ASA Closed Claims Project: Regional Anesthesia Claims 1990 or later Lorri A. Lee MD Department of Anesthesiology, Seattle, WA
OVERVIEW 1. Closed Claims Project 2. Peripheral Nerve Blocks 3. Neuraxial Claims
ASA Closed Claims Project 35 insurance organizations since 1985 17 companies in current active panel 13,000+ anesthesiologists insured by current panel of companies
On Site Anesthesiologist Reviewer Within 5 years of practicing Non-dental injury claims Adequate records to recreate scenario Assessment of anesthetic related injury Assessment of SOC Severity of Injury Scale of No Injury (0) to Death (9)
Claims sent to Reviewed by 2 anesthesiologists Tie breaker resolved by 3 rd anesthesiologist Entered into CCP Database Topics selected, analyzed, updated
Utility of Closed Claims Data Collection of Sentinel Events Identify areas of recurrent risk Provide direction for in-depth analysis Snapshot of anesthesia liability
Bias with Malpractice Claims No denominator for calculating risk Small subset of injuries More severe, permanent injuries More substandard anesthesia care
COMPLICATIONS OF REGIONAL ANESTHESIA Neuraxial cardiac arrest High block Unintentional intravenous injection Hematoma, abscess, meningitis Needle trauma: Paresthesia, weakness, paralysis Blindness Post-dural puncture headache Complications of sedation Inadequate analgesia, injection site pain Miscellaneous
Peripheral Nerve Block Complications Complications Associated With Peripheral Nerve Blocks: Lessons From The ASA Closed Claims Project Lee LA, Posner KL, Kent C, Domino KB Int Anesthesiol Clin. 2011;49(3):56-67
Peripheral Nerve Block Complications Inclusion Criteria: Peripheral Block Claims from 1990 and later Operative setting Blocks performed in the OR for post-operative pain management included
Peripheral Nerve Block Complications Exclusion Criteria: Claims from 1970-1989 or unknown year Claims for: Chronic or postoperative pain management Eye Block claims
Peripheral Nerve Block Claims % of 189 claims Sex Age, mean (yrs) 57% male 47 +/- 14 yrs (range 4-80 yrs) ASA 1-2 69% ASA 3-4 17% Outpatient Surgery 64%
Supraclavicular Type of Blocks Associated with 189 Peripheral Nerve Block Claims Other Ankle Femoral IVRA Axillary Interscalene 0% 20% 40% 60%
80% Severity of Injury for 189 Peripheral Nerve Block Claims 60% 40% 20% 0% Temporary/ Permanent/ Brain Death Non-disabling Disabling Damage
Block-related Injuries per Severity of Injury Group in 189 Peripheral Nerve Block Claims 100% 80% 60% 40% 20% 0% Block-related Non-block-related Temporary/ Permanent/ Death or Brain Non-disabling Disabling Damage (n=129) (n=30) (n=30)
Peripheral Nerve Block Claims Temporary / Non-disabling Injury (n = 129) Block-related (% of 129) 71 (55%) Type of Block: Interscalene 50 (39%) Axillary 34 (26%) IVRA 17 (13%) Other 28 (22%)
CASE PRESENTATION A 30 year old female Carpal tunnel release supraclavicular block. PACU: "difficulty with a large breath". An X-ray showed 20% pneumothorax. The patient was not counseled for this on the preoperative anesthesia consent form. The case was settled for $20,000.
Peripheral Nerve Block Claims Permanent / Disabling Injury (n = 30) Block-related (% of 30) 21 (70%) Type of Block: Interscalene 14 (47%) Axillary 9 (30%) IVRA 2 ( 7%) Other 5 (16%)
Peripheral Nerve Block Claims Death / Brain Damage (n =30 ) Block-related (% of 30) 8 (27%) Type of Block: Interscalene 15 (50%) Axillary 7 (23%) IVRA 1 ( 3%) Other 7 (23%)
Most Common Complications in 189 Peripheral Nerve Blocks Brain Damage Pneumothorax Death Nerve Injury 0% 20% 40% 60%
Damaging Events in 189 Peripheral Nerve Block Claims Damaging Event N (% of 189) Block-related 100 (53%) Other Block-related* 65 (34%) Pneumothorax 12 (6%) Inadvertent I.V. Injection 10 (5%) Unexplained 7 (4%) High Block 4 (2%) Inadequate Analgesia 2 (1%) *Needle damage to spinal cord or nerves, intraneural injection, hematoma, infection, etc
University *Includes of Washington 7 claims with wrong-site block Damaging Events in 189 Peripheral Nerve Block Claims Damaging Event N (% of 189) Non-Block-related 89 (47%) Surgical / Patient Condition 18 (10%) Other Anesthetic Events* 14 (7%) Wrong Drug / Dose 12 (6%) Cardiovascular Events 12 (6%) Respiratory Events 11 (6%) Equipment Problems 4 (2%) No Event / Unspecified 18 (9%)
Location and Severity of 97 Nerve Injuries other sciatic radial femoral phrenic spinal cord ulnar median brachial plexus Temporary Injury Permanent Injury 0% 20% 40%
Mechanism of Injury in 97 Nerve Injury Claims Miscellaneous Causes, 25%* No Injury, 3% Block-related, 68% Unclear Mechanism, 4% *Includes pre-existing nerve injury, surgery, etc.
Mechanism of Injury for Peripheral Nerve Block Claims with Death or Brain Damage (n = 30) Local Anesthetic Toxicity 7 Inadvertent Intravenous Injection / Absorption 5 Wrong Dose 2 Stroke 6 Prolonged Hypotension 5 (Beach Chair Position) (4) Uncontrolled Preoperative Hypertension 1 N
Mechanism of Injury for Peripheral Nerve Block Claims with Death or Brain Damage (n = 30) Premature Extubation / Hypoxia on PACU Arrival 3 Spinal Cord Injection under General Anesthesia 2 Inadvertent Intrathecal Injection 1 Myocardial Infarction 2 Other Respiratory / Cardiac Arrest 3 Other Damaging Events 7 N
CASE PRESENTATION A 60 year old ASA 2 male w/ htn Humerus fx under ISB w/ nerve stimulator After the injection of 40ml of bupivacaine in divided doses, the patient had a seizure. The patient complained SOB prior to the seizure. A resident aspirated during the injection. GA immediately induced. No postop problems in the hospital record. 3 yrs later: suit for brain damage - memory loss and cognitive dysfunction. Neurologists had conflicting views as to the extent and cause. The case went to trial and the jury awarded $3M. The judge reduced it to $1.5 million and the anesthesiologist settled for $950,000.
Assessment of Standard of Care in 189 Peripheral Nerve Block Claims Impossible to Judge, 10% Less than Appropriate, 25% Appropriate, 65%
Summary for Peripheral Nerve Block Claims Overall, low percentage of total claims 2/3 of claims with temporary injuries 1/3 of claims with high severity injuries o 50% block-related Most commonly nerve injury and local anesthetic toxicity Need protocols to prevent wrong site blocks
Neuraxial Regional Complications Complications Associated with Regional Anesthesia and Pain Medicine: Findings From The ASA Closed Claims Project Lee LA, Fitzgibbon D, Stephens LS, Domino KB in Complications in Regional Anesthesia and Pain Medicine Neal and Rathmell, eds.
Neuraxial Regional Complications Inclusion Criteria: Neuraxial Regional Claims from 1990 and later Operative setting Blocks performed in the OR for postoperative pain management included
Neuraxial Regional Complications Exclusion Criteria: Claims from 1970-1989 or unknown year Claims for: chronic or postoperative pain management Obstetric claims
Neuraxial Regional Claims % of 443 claims Age, mean (yrs) Sex 57yrs (0.25-94 yrs) 51% male ASA 1-2 52% ASA 3-4 48% Obesity 31%
Type of Neuraxial Block in 443 Claims Thoracic Epidural, 5% Lumbar Epidural, 45% Combined Spinal + Epidural, 2% Subarachnoid, 45% Caudal Epidural, 1%
Most Common Block-Related Damaging Events for Neuraxial Regional Claims (n=181) 60% 40% 20% 0% Nerve Damage Neuraxial Cardiac Arrest Dural Puncture High Block
Non-Block-related Damaging Events in 433 Neuraxial Regional Claims Non-Block-related 59% % of 443 Cardiovascular Event 14% Respiratory Event 9% No Event 9% Surgical / Patient Condition 8% Equipment 7% Medication 4% Unknown 4% Other 4%
Mechanism of Injury in 163 Neuraxial Regional Claims Associated with Death or Brain Damage
Type of Block in 37 Neuraxial Arrest Claims % of 37 Subarachnoid 65% Epidural 35% Accidental Subarachnoid Block 11% Inadequate Test Dose 3%
Associated Factors in 37 Neuraxial Arrest Claims % of 37 Pulse Oximetry 81% Capnography 32% Sedation 76% Resuscitation Delay 49% Arrest in Prone Position 16% Repositioning on Table 18% Epinephrine Not Administered 5%
Associated Factors for High Blocks (n = 14) Subarachnoid 5 Epidural 9 Accidental Subarachnoid 9 Mean Age (yrs) 52 (0.25-76) Sex 50% male N
Mechanism of Injury for Permanent Nerve Injury Claims with Neuraxial Anesthesia (n = 71).
Associated Factors for Neuraxial Hematomas (n = 27) N (% of 27) Vascular 13 (48%) Orthopedic 9 (33%) Abdomino-pelvic 5 (19%) Coagulopathy 16 (59%) Needle Trauma 6 (22%) Catheter Removal on Anticoagulation 4 (15%)
Associated Factors for Neuraxial Hematomas (n = 27) Symptom Onset N (% of 27) POD 0 9 (33%) POD 1 5 (19%) POD >1 5 (19%) Delay in Diagnosis / Treatment 11 (41%) Failure of Block Resolution POD 0 9 (33%) Increased Motor Block 6 (22%) Back Pain 5 (19%)
Diagnosis of Neuraxial Hematoma MRI T2 weighted image CT myelography (plain CT may miss epidural hematoma)
Treatment of Neuraxial Hematoma Prompt Surgical Evacuation Time from symptom onset to decompression and the severity of neurological deficits prior to decompression correlate with recovery
CASE PRESENTATION 68 year old male SAB for balloon angioplasty of the left iliac artery Back pain after the spinal wore off in the PACU Delay in workup epidural hematoma Permanent paraplegia Settlement $1.65 million
Associated Factors for Cauda Equina Claims with Neuraxial Anesthesia (n = 15) Lidocaine 13 Chlorprocaine 1 No local anesthetic (needle trauma) 1 Claims with Permanent Injury 14 Subarachnoid 8 Epidural 4 (Accidental subarachnoid block) (1) Combined spinal + epidural 2 N
Complications with Temporary Injury Claims with Neuraxial Anesthesia (n = 198).
Summary for Neuraxial Regional Claims > 1/3 of neuraxial claims with death or brain damage < 50% of neuraxial claims with temporary injury Maintain vigilance for neuraxial cardiac arrest and have full resuscitative equipment and drugs available at all times Use test doses to prevent accidental subarachnoid blocks and maintain vigilance for high blocks Avoid > 1% lidocaine for subarachnoid blocks Judicious use of neuraxial anesthesia in patients with University coagulopathy of Washington and high vigilance for neuraxial hematoma