Prolonged Opioid Use and Pain Outcome and Associated Factors after Surgery under General Anesthesia: A Prospective Cohort Association Multicenter Study.

BACKGROUND: There is insufficient prospective evidence regarding the relationship between surgical experience and prolonged opioid use and pain. The authors investigated the association of patient characteristics, surgical procedure, and perioperative anesthetic course with postoperative opioid consumption and pain 3 months postsurgery. The authors hypothesized that patient characteristics and intraoperative factors predict opioid consumption and pain 3 months postsurgery. METHODS: Eleven U.S. and one European institution enrolled patients scheduled for spine, open thoracic, knee, hip, or abdominal surgery, or mastectomy, in this multicenter, prospective observational study. Preoperative and postoperative data were collected using patient surveys and electronic medical records. Intraoperative data were collected from the Multicenter Perioperative Outcomes Group database. The association between postoperative opioid consumption and surgical site pain at 3 months, elicited from a telephone survey conducted at 3 months postoperatively, and demographics, psychosocial scores, pain scores, pain management, and case characteristics, was analyzed. RESULTS: Between September and October 2017, 3,505 surgical procedures met inclusion criteria. A total of 1,093 cases were included; 413 patients were lost to follow-up, leaving 680 (64%) for outcome analysis. Preoperatively, 135 (20%) patients were taking opioids. Three months postsurgery, 96 (14%) patients were taking opioids, including 23 patients (4%) who had not taken opioids preoperatively. A total of 177 patients (27%) reported surgical site pain, including 45 (13%) patients who had not reported pain preoperatively. The adjusted odds ratio for 3-month opioid use was 18.6 (credible interval, 10.3 to 34.5) for patients who had taken opioids preoperatively. The adjusted odds ratio for 3-month surgical site pain was 2.58 (1.45 to 4.4), 4.1 (1.73 to 8.9), and 2.75 (1.39 to 5.0) for patients who had site pain preoperatively, knee replacement, or spine surgery, respectively. CONCLUSIONS: Preoperative opioid use was the strongest predictor of opioid use 3 months postsurgery. None of the other variables showed clinically significant association with opioid use at 3 months after surgery.

Practice Patterns and Variability in Intraoperative Opioid Utilization: A Report From the Multicenter Perioperative Outcomes Group.

BACKGROUND: Opioids remain the primary mode of analgesia intraoperatively. There are limited data on how patient, procedural, and institutional characteristics influence intraoperative opioid administration. The aim of this retrospective, longitudinal study from 2012 to 2016 was to assess how intraoperative opioid dosing varies by patient and clinical care factors and across multiple institutions over time. METHODS: Demographic, surgical procedural, anesthetic technique, and intraoperative analgesia data as putative variables of intraoperative opioid utilization were collected from 10 institutions. Log parenteral morphine equivalents (PME) was modeled in a multivariable linear regression model as a function of 15 covariates: 3 continuous covariates (age, anesthesia duration, year) and 12 factor covariates (peripheral block, neuraxial block, general anesthesia, emergency status, race, sex, remifentanil infusion, major surgery, American Society of Anesthesiologists [ASA] physical status, non-opioid analgesic count, Multicenter Perioperative Outcomes Group [MPOG] institution, surgery category). One interaction (year by MPOG institution) was included in the model. The regression model adjusted simultaneously for all included variables. Comparison of levels within a factor were reported as a ratio of medians with 95% credible intervals (CrI). RESULTS: A total of 1,104,324 cases between January 2012 and December 2016 were analyzed. The median (interquartile range) PME and standardized by weight PME per case for the study period were 15 (10-28) mg and 200 (111-347) µg/kg, respectively. As estimated in the multivariable model, there was a sustained decrease in opioid use (mean, 95% CrI) dropping from 152 (151-153) µg/kg in 2012 to 129 (129-130) µg/kg in 2016. The percent of variability in PME due to institution was 25.6% (24.8%-26.5%). Less opioids were prescribed in men (130 [129-130] µg/kg) than women (144 [143-145] µg/kg). The men to women PME ratio was 0.90 (0.89-0.90). There was substantial variability in PME administration among institutions, with the lowest being 80 (79-81) µg/kg and the highest being 186 (184-187) µg/kg; this is a PME ratio of 0.43 (0.42-0.43). CONCLUSIONS: We observed a reduction in intraoperative opioid administration over time, with variability in dose ranging between sexes and by procedure type. Furthermore, there was substantial variability in opioid use between institutions even when adjusting for multiple variables.

Pulmonary Aspiration of Gastric Contents: A Closed Claims Analysis.

BACKGROUND: Perioperative pulmonary aspiration of gastric contents has been associated with severe morbidity and death. The primary aim of this study was to identify outcomes and patient and process of care risk factors associated with gastric aspiration claims in the Anesthesia Closed Claims Project. The secondary aim was to assess these claims for appropriateness of care. The hypothesis was that these data could suggest opportunities to reduce either the risk or severity of perioperative pulmonary aspiration. METHODS: Inclusion criteria were anesthesia malpractice claims in the American Society of Anesthesiologists Closed Claims Project that were associated with surgical, procedural, or obstetric anesthesia care with the year of the aspiration event 2000 to 2014. Claims involving pulmonary aspiration were identified and assessed for patient and process factors that may have contributed to the aspiration event and outcome. The standard of care was assessed for each claim. RESULTS: Aspiration of gastric contents accounted for 115 of the 2,496 (5%) claims in the American Society of Anesthesiologists Closed Claims Project that met inclusion criteria. Death directly related to pulmonary aspiration occurred in 66 of the 115 (57%) aspiration claims. Another 16 of the 115 (14%) claims documented permanent severe injury. Seventy of the 115 (61%) patients who aspirated had either gastrointestinal obstruction or another acute intraabdominal process. Anesthetic management was judged to be substandard in 62 of the 115 (59%) claims. CONCLUSIONS: Death and permanent severe injury were common outcomes of perioperative pulmonary aspiration of gastric contents in this series of closed anesthesia malpractice claims. The majority of the patients who aspirated had either gastrointestinal obstruction or acute intraabdominal processes. Anesthesia care was frequently judged to be substandard. These findings suggest that clinical practice modifications to preoperative assessment and anesthetic management of patients at risk for pulmonary aspiration may lead to improvement of their perioperative outcomes.

Communication failures contributing to patient injury in anaesthesia malpractice claims☆.

BACKGROUND: Communication amongst team members is critical to providing safe, effective medical care. We investigated the role of communication failures in patient injury using the Anesthesia Closed Claims Project database. METHODS: Claims associated with surgical/procedural and obstetric anaesthesia and postoperative pain management for adverse events from 2004 or later were included. Communication was defined as transfer of information between two or more parties. Failure was defined as communication that was incomplete, inaccurate, absent, or not timely. We classified root causes of failures as content, audience, purpose, or occasion with inter-rater reliability assessed by kappa. Claims with communication failures contributing to injury (injury-related communication failures; n=389) were compared with claims without any communication failures (n=521) using Fisher's exact test, t-test, or Mann-Whitney U-tests. RESULTS: At least one communication failure contributing to patient injury occurred in 43% (n=389) out of 910 claims (κ=0.885). Patients in claims with injury-related communication failures were similar to patients in claims without failures, except that failures were more common in outpatient settings (34% vs 26%; P=0.004). Fifty-two claims had multiple communication failures for a total of 446 injury-related failures, and 47% of failures occurred during surgery, 28% preoperatively, and 23% postoperatively. Content failures (insufficient, inaccurate, or no information transmitted) accounted for 60% of the 446 communication failures. CONCLUSIONS: Communication failure contributed to patient injury in 43% of anaesthesia malpractice claims. Patient/case characteristics in claims with communication failures were similar to those without failures, except that failures were more common in outpatient settings.

Development and Evaluation of a Risk-Adjusted Measure of Intraoperative Hypotension in Patients Having Nonemergent, Noncardiac Surgery.

BACKGROUND: Intraoperative hypotension is common and associated with organ injury and death, although randomized data showing a causal relationship remain sparse. A risk-adjusted measure of intraoperative hypotension may therefore contribute to quality improvement efforts. METHODS: The measure we developed defines hypotension as a mean arterial pressure <65 mm Hg sustained for at least 15 cumulative minutes. Comparisons are based on whether clinicians have more or fewer cases of hypotension than expected over 12 months, given their patient mix. The measure was developed and evaluated with data from 225,389 surgeries in 5 hospitals. We assessed discrimination and calibration of the risk adjustment model, then calculated the distribution of clinician-level measure scores, and finally estimated the signal-to-noise reliability and predictive validity of the measure. RESULTS: The risk adjustment model showed acceptable calibration and discrimination (area under the curve was 0.72 and 0.73 in different validation samples). Clinician-level, risk-adjusted scores varied widely, and 36% of clinicians had significantly more cases of intraoperative hypotension than predicted. Clinician-level score distributions differed across hospitals, indicating substantial hospital-level variation. The mean signal-to-noise reliability estimate was 0.87 among all clinicians and 0.94 among clinicians with >30 cases during the 12-month measurement period. Kidney injury and in-hospital mortality were most common in patients whose anesthesia providers had worse scores. However, a sensitivity analysis in 1 hospital showed that score distributions differed markedly between anesthesiology fellows and attending anesthesiologists or certified registered nurse anesthetists; score distributions also varied as a function of the fraction of cases that were inpatients. CONCLUSIONS: Intraoperative hypotension was common and was associated with acute kidney injury and in-hospital mortality. There were substantial variations in clinician-level scores, and the measure score distribution suggests that there may be opportunity to reduce hypotension which may improve patient safety and outcomes. However, sensitivity analyses suggest that some portion of the variation results from limitations of risk adjustment. Future versions of the measure should risk adjust for important patient and procedural factors including comorbidities and surgical complexity, although this will require more consistent structured data capture in anesthesia information management systems. Including structured data on additional risk factors may improve hypotension risk prediction which is integral to the measure's validity.

Forecasting a Crisis: Machine-Learning Models Predict Occurrence of Intraoperative Bradycardia Associated With Hypotension.

BACKGROUND: Predictive analytics systems may improve perioperative care by enhancing preparation for, recognition of, and response to high-risk clinical events. Bradycardia is a fairly common and unpredictable clinical event with many causes; it may be benign or become associated with hypotension requiring aggressive treatment. Our aim was to build models to predict the occurrence of clinically significant intraoperative bradycardia at 3 time points during an operative course by utilizing available preoperative electronic medical record and intraoperative anesthesia information management system data. METHODS: The analyzed data include 62,182 scheduled noncardiac procedures performed at the University of Washington Medical Center between 2012 and 2017. The clinical event was defined as severe bradycardia (heart rate <50 beats per minute) followed by hypotension (mean arterial pressure <55 mm Hg) within a 10-minute window. We developed models to predict the presence of at least 1 event following 3 time points: induction of anesthesia (TP1), start of the procedure (TP2), and 30 minutes after the start of the procedure (TP3). Predictor variables were based on data available before each time point and included preoperative patient and procedure data (TP1), followed by intraoperative minute-to-minute patient monitor, ventilator, intravenous fluid, infusion, and bolus medication data (TP2 and TP3). Machine-learning and logistic regression models were developed, and their predictive abilities were evaluated using the area under the ROC curve (AUC). The contribution of the input variables to the models were evaluated. RESULTS: The number of events was 3498 (5.6%) after TP1, 2404 (3.9%) after TP2, and 1066 (1.7%) after TP3. Heart rate was the strongest predictor for events after TP1. Occurrence of a previous event, mean heart rate, and mean pulse rates before TP2 were the strongest predictor for events after TP2. Occurrence of a previous event, mean heart rate, mean pulse rates before TP2 (and their interaction), and 15-minute slopes in heart rate and blood pressure before TP2 were the strongest predictors for events after TP3. The best performing machine-learning models including all cases produced an AUC of 0.81 (TP1), 0.87 (TP2), and 0.89 (TP3) with positive predictive values of 0.30, 0.29, and 0.15 at 95% specificity, respectively. CONCLUSIONS: We developed models to predict unstable bradycardia leveraging preoperative and real-time intraoperative data. Our study demonstrates how predictive models may be utilized to predict clinical events across multiple time intervals, with a future goal of developing real-time, intraoperative, decision support.

Postoperative Critical Events Associated With Obstructive Sleep Apnea: Results From the Society of Anesthesia and Sleep Medicine Obstructive Sleep Apnea Registry.

BACKGROUND: Obstructive sleep apnea (OSA) patients are at increased risk for pulmonary and cardiovascular complications; perioperative mortality risk is unclear. This report analyzes cases submitted to the OSA Death and Near Miss Registry, focusing on factors associated with poor outcomes after an OSA-related event. We hypothesized that more severe outcomes would be associated with OSA severity, less intense monitoring, and higher cumulative opioid doses. METHODS: Inclusion criteria were age ≥18 years, OSA diagnosed or suspected, event related to OSA, and event occurrence 1992 or later and <30 days postoperatively. Factors associated with death or brain damage versus other critical events were analyzed by tests of association and odds ratios (OR; 95% confidence intervals [CIs]). RESULTS: Sixty-six cases met inclusion criteria with known OSA diagnosed in 55 (83%). Patients were middle aged (mean = 53, standard deviation [SD] = 15 years), American Society of Anesthesiologists (ASA) III (59%, n = 38), and obese (mean body mass index [BMI] = 38, SD = 9 kg/m); most had inpatient (80%, n = 51) and elective (90%, n = 56) procedures with general anesthesia (88%, n = 58). Most events occurred on the ward (56%, n = 37), and 14 (21%) occurred at home. Most events (76%, n = 50) occurred within 24 hours of anesthesia end. Ninety-seven percent (n = 64) received opioids within the 24 hours before the event, and two-thirds (41 of 62) also received sedatives. Positive airway pressure devices and/or supplemental oxygen were in use at the time of critical events in 7.5% and 52% of cases, respectively. Sixty-five percent (n = 43) of patients died or had brain damage; 35% (n = 23) experienced other critical events. Continuous central respiratory monitoring was in use for 3 of 43 (7%) of cases where death or brain damage resulted. Death or brain damage was (1) less common when the event was witnessed than unwitnessed (OR = 0.036; 95% CI, 0.007-0.181; P < .001); (2) less common with supplemental oxygen in place (OR = 0.227; 95% CI, 0.070-0.740; P = .011); (3) less common with respiratory monitoring versus no monitoring (OR = 0.109; 95% CI, 0.031-0.384; P < .001); and (4) more common in patients who received both opioids and sedatives than opioids alone (OR = 4.133; 95% CI, 1.348-12.672; P = .011). No evidence for an association was observed between outcomes and OSA severity or cumulative opioid dose. CONCLUSIONS: Death and brain damage were more likely to occur with unwitnessed events, no supplemental oxygen, lack of respiratory monitoring, and coadministration of opioids and sedatives. It is important that efforts be directed at providing more effective monitoring for OSA patients following surgery, and clinicians consider the potentially dangerous effects of opioids and sedatives-especially when combined-when managing OSA patients postoperatively.

Multicenter Perioperative Outcomes Group Enhanced Observation Study Postoperative Pain Profiles, Analgesic Use, and Transition to Chronic Pain and Excessive and Prolonged Opioid Use Patterns Methodology.

To study the impact of anesthesia opioid-related outcomes and acute and chronic postsurgical pain, we organized a multicenter study that comprehensively combined detailed perioperative data elements from multiple institutions. By combining pre- and postoperative patient-reported outcomes with automatically extracted high-resolution intraoperative data obtained through the Multicenter Perioperative Outcomes Group (MPOG), the authors sought to describe the impact of patient characteristics, preoperative psychological factors, surgical procedure, anesthetic course, postoperative pain management, and postdischarge pain management on postdischarge pain profiles and opioid consumption patterns. This study is unique in that it utilized multicenter prospective data collection using a digital case report form integrated with the MPOG framework and database. Therefore, the study serves as a model for future studies using this innovative method. Full results will be reported in future articles; the purpose of this article is to describe the methods of this study.

Haematoma, abscess or meningitis after neuraxial anaesthesia in the USA and the Netherlands: A closed claims analysis.

BACKGROUND: Severe complications after neuraxial anaesthesia are rare but potentially devastating. OBJECTIVE: We aimed to identify characteristics and preventable causes of haematoma, abscess or meningitis after neuraxial anaesthesia. DESIGN: Observational study, closed claims analysis. SETTING: Closed anaesthesia malpractice claims from the USA and the Netherlands were examined from 2007 until 2017. PATIENTS: Claims of patients with haematoma (n = 41), abscess (n = 18) or meningitis (n = 14) associated with neuraxial anaesthesia for labour, acute and chronic pain that initiated and closed between 2007 and 2017 were included. There were no exclusions. MAIN OUTCOME MEASURES: We analysed potential preventable causes in patient-related, neuraxial procedure-related, treatment-related and legal characteristics of these complications. RESULTS: Patients experiencing spinal haematoma were predominantly above 60 years of age and using antihaemostatic medication, whereas patients with abscess or meningitis were middle-aged, relatively healthy and more often involved in emergency interventions. Potential preventable causes of unfavourable sequelae constituted errors in timing/prescription of antihaemostatic medication (10 claims, 14%), unsterile procedures (n = 10, 14%) and delay in diagnosis/treatment of the complication (n = 18, 25%). The number of claims resulting in payment was similar between countries (USA n = 15, 38% vs. the Netherlands n = 17, 52%; P = 0.25). The median indemnity payment, which the patient received varied widely between the USA (&OV0556;285 488, n = 14) and the Netherlands (&OV0556;31 031, n = 17) (P = 0.004). However, the considerable differences in legal systems and administration of expenses between countries may make meaningful comparison of indemnity payments inappropriate. CONCLUSIONS: Claims of spinal haematoma were often related to errors in antihaemostatic medication and delay in diagnosis and/or treatment. Spinal abscess claims were related to emergency interventions and lack of sterility. We wish to highlight these potential preventable causes, both when performing the neuraxial procedure and during postprocedural care of patients.

Management of Difficult Tracheal Intubation: A Closed Claims Analysis.

BACKGROUND: Difficult or failed intubation is a major contributor to morbidity for patients and liability for anesthesiologists. Updated difficult airway management guidelines and incorporation of new airway devices into practice may have affected patient outcomes. The authors therefore compared recent malpractice claims related to difficult tracheal intubation to older claims using the Anesthesia Closed Claims Project database. METHODS: Claims with difficult tracheal intubation as the primary damaging event occurring in the years 2000 to 2012 (n = 102) were compared to difficult tracheal intubation claims from 1993 to 1999 (n = 93). Difficult intubation claims from 2000 to 2012 were evaluated for preoperative predictors and appropriateness of airway management. RESULTS: Patients in 2000 to 2012 difficult intubation claims were sicker (78% American Society of Anesthesiologists [ASA] Physical Status III to V; n = 78 of 102) and had more emergency procedures (37%; n = 37 of 102) compared to patients in 1993 to 1999 claims (47% ASA Physical Status III to V; n = 36 of 93; P < 0.001 and 22% emergency; n = 19 of 93; P = 0.025). More difficult tracheal intubation events occurred in nonperioperative locations in 2000 to 2012 than 1993 to 1999 (23%; n = 23 of 102 vs. 10%; n = 10 of 93; P = 0.035). Outcomes differed between time periods (P < 0.001), with a higher proportion of death in 2000 to 2012 claims (73%; n = 74 of 102 vs. 42%; n = 39 of 93 in 1993 to 1999 claims; P < 0.001 adjusted for multiple testing). In 2000 to 2012 claims, preoperative predictors of difficult tracheal intubation were present in 76% (78 of 102). In the 97 claims with sufficient information for assessment, inappropriate airway management occurred in 73% (71 of 97; κ = 0.44 to 0.66). A "can't intubate, can't oxygenate" emergency occurred in 80 claims with delayed surgical airway in more than one third (39%; n = 31 of 80). CONCLUSIONS: Outcomes remained poor in recent malpractice claims related to difficult tracheal intubation. Inadequate airway planning and judgment errors were contributors to patient harm. Our results emphasize the need to improve both practitioner skills and systems response when difficult or failed tracheal intubation is encountered.

Perioperative Peripheral Nerve Injury After General Anesthesia: A Qualitative Systematic Review.

Perioperative peripheral nerve injury (PNI) is a well-recognized complication of general anesthesia that continues to result in patient disability and malpractice claims. However, the multifactorial etiology of PNI is often not appreciated in malpractice claims given that most PNI is alleged to be due to errors in patient positioning. New advances in monitoring may aid anesthesiologists in the early detection of PNI. This article reviews recent studies of perioperative PNI after general anesthesia and discusses the epidemiology and potential mechanisms of injury and preventive measures. We performed a systematic literature search, reviewed the available evidence, and identified areas for further investigation. We also reviewed perioperative PNI in the Anesthesia Closed Claims Project database for adverse events from 1990 to 2013. The incidence of perioperative PNI after general anesthesia varies considerably depending on the type of surgical procedure, the age and risk factors of the patient population, and whether the detection was made retrospectively or prospectively. Taken together, studies suggest that the incidence in a general population of surgical patients undergoing all types of procedures is <1%, with higher incidence in cardiac, neurosurgery, and some orthopedic procedures. PNI represent 12% of general anesthesia malpractice claims since 1990, with injuries to the brachial plexus and ulnar nerves representing two-thirds of PNI claims. The causes of perioperative PNI after general anesthesia are likely multifactorial, resulting in a "difficult to predict and prevent" phenomenon. Nearly half of the PNI closed claims did not have an obvious etiology, and most (91%) were associated with appropriate anesthetic care. Future studies should focus on the interaction between different mechanisms of insult, severity and duration of injury, and underlying neuronal reserves. Recent automated detection technology in neuromonitoring with somatosensory evoked potentials may increase the ability to identify at-risk patients and individualize patient management.

Frequency and Type of Situational Awareness Errors Contributing to Death and Brain Damage: A Closed Claims Analysis.

BACKGROUND: Situational awareness errors may play an important role in the genesis of patient harm. The authors examined closed anesthesia malpractice claims for death or brain damage to determine the frequency and type of situational awareness errors. METHODS: Surgical and procedural anesthesia death and brain damage claims in the Anesthesia Closed Claims Project database were analyzed. Situational awareness error was defined as failure to perceive relevant clinical information, failure to comprehend the meaning of available information, or failure to project, anticipate, or plan. Patient and case characteristics, primary damaging events, and anesthesia payments in claims with situational awareness errors were compared to other death and brain damage claims from 2002 to 2013. RESULTS: Anesthesiologist situational awareness errors contributed to death or brain damage in 198 of 266 claims (74%). Respiratory system damaging events were more common in claims with situational awareness errors (56%) than other claims (21%, P < 0.001). The most common specific respiratory events in error claims were inadequate oxygenation or ventilation (24%), difficult intubation (11%), and aspiration (10%). Payments were made in 85% of situational awareness error claims compared to 46% in other claims (P = 0.001), with no significant difference in payment size. Among 198 claims with anesthesia situational awareness error, perception errors were most common (42%), whereas comprehension errors (29%) and projection errors (29%) were relatively less common. CONCLUSIONS: Situational awareness error definitions were operationalized for reliable application to real-world anesthesia cases. Situational awareness errors may have contributed to catastrophic outcomes in three quarters of recent anesthesia malpractice claims.Situational awareness errors resulting in death or brain damage remain prevalent causes of malpractice claims in the 21st century.

Delayed Detection of Esophageal Intubation in Anesthesia Malpractice Claims: Brief Report of a Case Series.

This retrospective case series analyzed 45 malpractice claims for delayed detection of esophageal intubation from the Anesthesia Closed Claims Project. Inclusion criteria were cases from 1995 to 2013, after adoption of identification of CO2 in expired gas to verify correct endotracheal tube position as a monitoring standard by the American Society of Anesthesiologists. Forty-nine percent (95% confidence interval 34%-64%) occurred in the operating room or other anesthesia location where CO2 detection equipment should have been available. The most common factors contributing to delayed detection were not using, ignoring, or misinterpreting CO2 readings. Misdiagnosis, as with bronchospasm, occurred in 33% (95% confidence interval 20%).

What Adverse Events and Injuries Are Cited in Anesthesia Malpractice Claims for Nonspine Orthopaedic Surgery?

BACKGROUND: Malpractice claims that arise during the perioperative care of patients receiving orthopaedic procedures will frequently involve both orthopaedic surgeons and anesthesiologists. The Anesthesia Closed Claims database contains anesthesia malpractice claim data that can be used to investigate patient safety events arising during the care of orthopaedic patients and can provide insight into the medicolegal liability shared by the two specialties. QUESTIONS/PURPOSES: (1) How do orthopaedic anesthetic malpractice claims differ from other anesthesia claims with regard to patient and case characteristics, common events and injuries, and liability profile? (2) What are the characteristics of patients who had neuraxial hematomas after spinal and epidural anesthesia for orthopaedic procedures? (3) What are the characteristics of patients who had orthopaedic anesthesia malpractice claims for central ischemic neurologic injury occurring during shoulder surgery in the beach chair position? (4) What are the characteristics of patients who had malpractice claims for respiratory depression and respiratory arrests in the postoperative period? METHODS: The Anesthesia Closed Claims Project database was the source of data for this study. This national database derives data from a panel of liability companies (national and regional) and includes closed malpractice claims against anesthesiologists representing > 30% of practicing anesthesiologists in the United States from all types of practice settings (hospital, surgery centers, and offices). Claims for damage to teeth or dentures are not included in the database. Patient characteristics, type of anesthesia, damaging events, outcomes, and liability characteristics of anesthesia malpractice claims for events occurring in the years 2000 to 2013 related to nonspine orthopaedic surgery (n = 475) were compared with claims related to other procedures (n = 1592) with p < 0.05 as the criterion for statistical significance and two-tailed tests. Odds ratios and their 95% confidence intervals were calculated for all comparisons. Three types of claims involving high-impact injuries in patients undergoing nonspine orthopaedic surgery were identified through database query for in-depth descriptive review: neuraxial hematoma (n = 10), central ischemic neurologic injury in the beach chair position (n = 9), and injuries caused by postoperative respiratory depression (n = 23). RESULTS: Nonspine orthopaedic anesthesia malpractice claims were more frequently associated with nerve injuries (125 of 475 [26%], odds ratio [OR] 2.12 [1.66-2.71]) and events arising from the use of regional anesthesia (125 of 475 [26%], OR 6.18 (4.59-8.32) than in malpractice claims in other areas of anesthesia malpractice (230 of 1592 [14%] and 87 of 1592 [6%], respectively, p < 0.001 for both comparisons). Ninety percent (nine of 10) of patients with claims for neuraxial hematomas were receiving anticoagulant medication and all had severe long-term injuries, most with a history of significant delay in diagnosis and treatment after first appearance of signs and symptoms. Central ischemic injuries occurring during orthopaedic surgery in the beach chair position did not occur solely in patients who would have been considered at high risk for ischemic stroke. Patients with malpractice claims for injuries resulting from postoperative respiratory depression events had undergone lower extremity procedures (20 of 23 [87%]) and most events (22 of 23 [96%]) occurred on the day of surgery or the first postoperative day. CONCLUSIONS: Nonspine orthopaedic anesthesia malpractice claims more frequently cited nerve injury and events arising from the use of regional anesthesia than other surgical anesthesia malpractice claims. This may reflect the frequency of regional anesthesia in orthopaedic cases rather than increased risk of injury associated with regional techniques. When neuraxial procedures and anticoagulation regimens are used concurrently, care pathways should emphasize clear lines of responsibility for coordination of care and early investigation of any unusual neurologic findings that might indicate neuraxial hematoma. We do not have a good understanding of the factors that render some patients vulnerable to the rare occurrence of intraoperative central ischemic injury in the beach chair position, but providers should carefully calculate cerebral perfusion pressure relative to measured blood pressure for patients in the upright position. Postoperative use of multiple opioids by different concurrent modes of administration warrant special precautions with consideration given to the provision of care in settings with enhanced respiratory monitoring. The limitations of retrospective closed claims database review prevent conclusions regarding causation. Nonetheless, the collection of relatively rare events with substantial clinical detail provides valuable data to generate hypotheses about causation with potential for future study to improve patient safety. LEVEL OF EVIDENCE: Level III, therapeutic study.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Trends in Pain Medicine Liability.

BACKGROUND: The authors examined changes in the frequency of pain medicine malpractice claims and associated treatment modalities and outcomes over time. METHODS: The authors analyzed trends in pain medicine claims from 1980 to 2012 in the Anesthesia Closed Claims Project database by binary logistic regression on year of event. Pain procedures in claims from 2000 to 2012 were compared with the proportion of pain procedures reported to the National Anesthesia Clinical Outcomes Registry in 2010-2014. RESULTS: Malpractice claims for pain medicine increased from 3% of 2,966 total malpractice claims in the Anesthesia Closed Claims Project database in 1980-1989 to 18% of 2,743 anesthesia claims in 2000-2012 (odds ratio [OR], 1.088 per year; 95% CI, 1.078 to 1.098; P < 0.001). Outcomes in pain claims became more severe over time, with increases in death and permanent disabling injury (OR, 1.094 per year; P < 0.001). Nonneurolytic cervical injections increased to 27% of pain claims in 2000-2012 (OR, 1.054; P < 0.001), whereas National Anesthesia Clinical Outcomes Registry demonstrates that lumbar injections are a more common procedure. Claims associated with medication management increased to 17% of pain claims in 2000-2012 (OR, 1.116 per year; P < 0.001). CONCLUSIONS: Pain medicine claims have increased over time and have increased in severity. Claims related to cervical procedures were out of proportion to the frequency with which they are performed. These liability findings suggest that pain specialists should aggressively continue the search for safer and more effective therapies.

Postoperative opioid-induced respiratory depression: a closed claims analysis.

BACKGROUND: Postoperative opioid-induced respiratory depression (RD) is a significant cause of death and brain damage in the perioperative period. The authors examined anesthesia closed malpractice claims associated with RD to determine whether patterns of injuries could guide preventative strategies. METHODS: From the Anesthesia Closed Claims Project database of 9,799 claims, three authors reviewed 357 acute pain claims that occurred between 1990 and 2009 for the likelihood of RD using literature-based criteria. Previously cited patient risk factors for RD, clinical management, nursing assessments, and timing of events were abstracted from claim narratives to identify recurrent patterns. RESULTS: RD was judged as possible, probable, or definite in 92 claims (κ = 0.690) of which 77% resulted in severe brain damage or death. The vast majority of RD events (88%) occurred within 24 h of surgery, and 97% were judged as preventable with better monitoring and response. Contributing and potentially actionable factors included multiple prescribers (33%), concurrent administration of nonopioid sedating medications (34%), and inadequate nursing assessments or response (31%). The time between the last nursing check and the discovery of a patient with RD was within 2 h in 42% and within 15 min in 16% of claims. Somnolence was noted in 62% of patients before the event. CONCLUSIONS: This claims review supports a growing consensus that opioid-related adverse events are multifactorial and potentially preventable with improvements in assessment of sedation level, monitoring of oxygenation and ventilation, and early response and intervention, particularly within the first 24 h postoperatively.

Massive hemorrhage: a report from the anesthesia closed claims project.

BACKGROUND: Hemorrhage is a potentially preventable cause of adverse outcomes in surgical and obstetric patients. New understanding of the pathophysiology of hemorrhagic shock, including development of coagulopathy, has led to evolution of recommendations for treatment. However, no recent study has examined the legal outcomes of these claims. The authors reviewed closed anesthesia malpractice claims related to hemorrhage, seeking common factors to guide future management strategies. METHODS: The authors analyzed 3,211 closed surgical or obstetric anesthesia malpractice claims from 1995 to 2011 in the Anesthesia Closed Claims Project. Claims where patient injury was attributed to hemorrhage were compared with all other surgical and obstetric claims. Risk factors for hemorrhage and coagulopathy, clinical factors, management, and communication issues were abstracted from claim narratives to identify recurrent patterns. RESULTS: Hemorrhage occurred in 141 (4%) claims. Obstetrics accounted for 30% of hemorrhage claims compared with 13% of nonhemorrhage claims (P < 0.001); thoracic or lumbar spine surgery was similarly overrepresented (24 vs. 6%, P < 0.001). Mortality was higher in hemorrhage than nonhemorrhage claims (77 vs. 27%, P < 0.001), and anesthesia care was more often judged to be less than appropriate (55 vs. 38%, P < 0.001). Median payments were higher in hemorrhage versus nonhemorrhage claims ($607,750 vs. $276,000, P < 0.001). Risk factors for hemorrhage and coagulopathy were common, and initiation of transfusion therapy was commonly delayed. CONCLUSIONS: Hemorrhage is a rare, but serious, cause of anesthesia malpractice claims. Understanding which patients are at risk can aid in patient referral decisions, design of institutional systems for responding to hemorrhage, and education of surgeons, obstetricians, and anesthesiologists.

Death or neurologic injury after tonsillectomy in children with a focus on obstructive sleep apnea: houston, we have a problem!

BACKGROUND: Obesity is epidemic in the United States and with it comes an increased incidence of obstructive sleep apnea (OSA). Evidence regarding opioid sensitivity as well as recent descriptions of deaths after tonsillectomy prompted a survey of all members of the Society for Pediatric Anesthesia regarding adverse events in children undergoing tonsillectomy. METHODS: An electronic survey was sent to 2377 members of the Society for Pediatric Anesthesia. Additionally, data from the American Society of Anesthesiologists Closed Claims Project were obtained. Adverse events during or after tonsillectomy with or without adenoidectomy in children were included. Children at risk for OSA were identified as either having a positive history for OSA or a post hoc application of the American Society of Anesthesiologists OSA practice guidelines. These children were compared with all other children by Fisher exact test for proportions and t test for continuous variables. RESULTS: A total of 129 cases were identified from the 731 replies to the survey, with 92 meeting inclusion criteria for having adequate data. Another 19 cases with adequate data were identified from the 45 from the American Society of Anesthesiologists Closed Claims Project. A total of 111 cases were included in the final analysis. Death and permanent neurologic injury occurred in 86 (77%) cases and were reported in the operating room, postanesthesia care unit, on the ward, and at home. Sixty-three (57%) children fulfilled American Society of Anesthesiologists criteria to be at risk for OSA. Children categorized as at risk for OSA were more likely than other children to be obese and to have comorbidities (P < 0.0001). A larger proportion of at risk children had the event attributed to apnea (P = 0.016), whereas all others had a larger proportion of events attributed to hemorrhage (P = 0.006). CONCLUSIONS: Deaths or neurologic injury after tonsillectomy due to apparent apnea in children suggest that at least 16 children could have been rescued had respiratory monitoring been continued throughout first- and second-stage recovery, as well as on the ward during the first postoperative night. A validated pediatric-specific risk assessment scoring system is needed to assist with identifying children at risk for OSA who are not appropriate to be cared for on an outpatient basis.