Abstract
Background
Despite the widespread use of regional anesthesia, limited information on clinical performance exists. Institutions, therefore, have little knowledge of how they are performing in regards to both safety and effectiveness. In this study, we demonstrate how a medical institution (or physician/physician group) may use data from a multi-center clinical registry of regional anesthesia to inform quality improvement strategies.
Methods
We analyzed data from the International Registry of Regional Anesthesia that includes prospective data on peripheral regional anesthesia procedures from 19 centers located around the world. Using data from the clinical registry, we present summary statistics of the overall safety and effectiveness of regional anesthesia. Furthermore, we demonstrate, using a variety of performance measures, how these data can be used by hospitals to identify areas for quality improvement. To do so, we compare the performance of one member institution (a United States medical center in New Hampshire) to that of the other 18 member institutions of the clinical registry.
Results
The clinical registry contained information on 23,271 blocks that were performed between June 1, 2011, and May 1, 2014, on 16,725 patients. The overall success rate was 96.7%, immediate complication rate was 2.2%, and the all-cause 60-day rate of neurological sequelae was 8.3 (95% CI, 7.2–9.7) per 10,000. Registry wide major hospital events included 7 wrong site blocks, 3 seizures, 1 complete heart block, 1 retroperitoneal hematoma, and 3 pneumothoraces. For our reference medical center, we identified areas meriting quality improvement. Specifically, after accounting for differences in the age, sex, and health status of patient populations, the reference medical center appeared to rely more heavily on opioids for post procedure management, had higher patient pain scores, and experienced delayed discharge when compared with other member institutions.
Conclusions
To our knowledge, this is the first large-scale effort to use a clinical registry to provide comparative outcome rates representing the safety and effectiveness of regional anesthesia. These results can be used to help inform quality improvement strategies.
Keywords: Regional Anesthesia, Safety, Complications, Nerve Block, Registry, Observational Data
INTRODUCTION
Regional anesthesia is an important component of perioperative health care, contributing to improved patient satisfaction and reduced opioid analgesic medication use.1 Three randomized, placebo-controlled studies conclusively demonstrated significant reductions in patient reported pain after shoulder, foot, and distal upper extremity surgery as a result of peripheral nerve block (PNB).2–4 However, like many medical and surgical procedures, trade-offs exist in clinical practice. Despite the recognized benefits of regional anesthesia, these procedures can also lead to quality compromising events. Possible morbidity from regional anesthesia ranges from relatively minor issues such as discomfort during block placement to death related to local anesthetic toxicity.5–7
Despite the popularity, changing nature of delivery, and potential clinical benefits of regional anesthesia, individual medical centers and physician groups have little knowledge of how they are performing from both a safety and effectiveness standpoint. Such data would be helpful for many scenarios such as the planning of quality improvement projects, departmental reporting, and the completion of the personal practice assessment component of the Maintenance of Certification in Anesthesiology (MOCA). Additionally, in the new era of Accountable Care Organizations (ACO), health care reform, and bundled payments, performance data will likely be progressively linked to reimbursement.8
Therefore, in an effort to begin to develop clinical benchmarks, we sought to present summary rates regarding the safety and effectiveness of PNB from an international clinical registry. To demonstrate the utility of the clinical registry, we also compared the performance of one member institution (located in New Hampshire, USA) to the rest of the registry and identified potential areas for quality improvement.
METHODS
International Registry of Regional Anesthesia
The International Registry of Regional Anesthesia (IRORA) is a prospective multi-center clinical registry that collects information on contemporary PNB practice. The study period for this current investigation is from June 1, 2011, to May 1, 2014, (35 total months of data) and, as of May 1, 2014, there were 19 contributing institutions. Detailed methodology for the clinical registry has been previously reported including definitions for immediate and delayed complications and follow-up protocol.9 Briefly, key features of the clinical registry include (1) a waiver of the entire consent process for data collection so that all eligible patients can be captured minimizing selection bias; (2) a web-based data collection interface providing the ability to gather information from a large number of patients close to the point of care, improving data integrity and reducing the burden of data collection; (3) data collection at the individual patient level; (4) Systematic postoperative contact with all patients; (5) a defined follow-up and investigative pathway; (6) a clear definition and verification of all key outcomes; and (7) a data quality assurance process that includes site visits, interviews, and chart reviews.
To demonstrate the utility of the clinical registry for informing improvement of care delivery, we selected one member institution, Dartmouth Hitchcock Medical Center (DHMC), to serve as a reference hospital. This institution contributed data between August 1, 2012, and May 1, 2014 (22 total months of data) to the IRORA.
The patient population of the DHMC comprised patients having PNB in the context of a surgical procedure. DHMC is a tertiary care academic medical center in New Hampshire associated with the Geisel School of Medicine at Dartmouth. DHMC offers a wide range of surgical and regional anesthetic procedures primarily for residents of the greater Northern New England area. We analyzed patients having PNBs associated with surgical procedures at DHMC and compared results to that at 18 other institutions associated with the IRORA in aggregate. The other 18 IRORA member institutions are listed in Appendix 1.
Regional Anesthesia at Dartmouth Hitchcock Medical Center
Patients arriving for surgical procedures at DHMC are evaluated by an anesthesia team. If appropriate, patients may elect to have a nerve block placed to either serve as the sole anesthetic or to provide postoperative analgesia. At DHMC, PNB are routinely performed in a block room with light sedation prior to the surgical procedure. Occasionally, PNBs are placed after the patient is under general anesthesia in the operating room. Postoperative care in the Post Anesthesia Care Unit (PACU) includes management of residual pain not covered by the PNB.
Measures of Safety and Effectiveness
Using the IRORA clinical registry, safety was assessed by quantifying immediate, PACU, and delayed complication rates. PNB related complications were defined, tracked, and pooled where appropriate. Immediate complications were complications that occurred during block placement and intraoperative period. PACU complications were complications recognized in the recovery phase of care. Delayed complications were assessed per the registry follow-up protocol and included procedure-related infections and all cause postoperative neurological sequelae present 60 days postoperatively.
We examined 4 different measures of the effectiveness of regional anesthesia. In the PACU, the following outcomes were recorded by nursing staff: 1) pain assessment was reported as the highest verbal analog score (VAS: 0, none; 10 worst pain ever experienced) recorded by nursing staff; 2) need for any supplemental opioid therapy and 3) the ability to be discharged from the PACU within 30 minutes using local discharge criteria. Procedure success 4) was determined by the physician performing the PNB and was defined as the development of anticipated clinical characteristics with evidence of sensory or motor effects.
Statistical Analyses
Simple descriptive statistics were used to examine the overall rates of the various outcomes for the entire IRORA clinical registry. To graphically examine the distributions of center-specific rates (and any potential variation across member institutions), we used turnip plots. In a cross sectional analysis, we used univariate statistics to compare the reference institution (DHMC) to the other 18 IRORA member institutions. Specifically, we used the chi-squared test to compare proportions for dichotomous outcomes (block success, opioid use, VAS score of 5 or higher, rapid PACU discharge) and a non-paired t-test to compare means for continuous measures (VAS scores, complication rates). We used generalized linear models with a logit link function to predict various dichotomous outcomes and to adjust for patient population differences including age, sex, body mass index (BMI), and American Society of Anesthesiologists (ASA) health status. In these analyses, our primary independent variable (included in our models as indicator variables that represented each institution) was the specific IRORA institution with DHMC used as the reference institution. For all analyses we set our critical alpha level to 0.05 (2-sided). We did not make adjustments for multiple comparisons. 95% CIs for the unadjusted major event rates were calculated using the binomial distribution. Statistical analyses were performed in Stata version 12 (College Station, Texas).
In order to gain insight into performance over time for DHMC, we examined selective variables using statistical process control (SPC) charts, p-charts.10 Statistical process control charts enrich simple aggregate data by examining temporal performance. Using standard SPC methods, we examined for special cause signals, which, if present, would suggest that the process is not in statistical control.10
RESULTS
Across all 19 IRORA member institutions, from June 1, 2011 to May 1, 2014, 23,271 PNBs were performed in 16,725 patients for 18,271 surgical procedures. Of these, DHMC performed 4,003 PNBs. Characteristics regarding the patient population and PNBs are displayed in Tables 1 and 2. Overall, summary rates regarding the effectiveness and safety of PNB were technical success, 96.7%; immediate complications, 2.2%; PACU complications, 0.53%. Major adverse events reported to the IRORA registry, were three seizures [1.3 (95% CI, 0.3–3.8) per 10,000], one complete heart block [0.4 (95% CI: 0.0– 2.3) per 10,000], one retroperitoneal hematoma [1.8 (95% CI, 0.0–9.9) per 10,000], and three pneumothoraces [6.6 (95% CI, 1.3–19.4) per 10,000], one complete heart block [0.4 (95% CI, 0.0–2.3) per 10,000]. At 60 days follow-up, there were 172 all-cause postoperative neurological sequelae [8.3 (95% CI, 7.2–9.7) per 10,000]. There were no cardiac arrests.
Table 1.
Characteristics of patientsΦ
| Mean (SD) or proportion | |||
|---|---|---|---|
| Characteristic | Other Hospitals n=13,677 |
Dartmouth n=3,048 |
p value* |
| Age (years) | 56.8 (19.9) | 56.7 (16.1) | NS |
| Sex (male) | 0.519 | 0.475 | <0.001 |
| BMI | 28.2 (6.7) | 30.1 (7.4) | <0.001 |
| ASA III or higher | 0.405 | 0.345 | <0.001 |
| Preoperative neuropathy | 0.064 | 0.077 | 0.001 |
| Diabetes | 0.183 | 0.121 | <0.001 |
| Cancer | 0.066 | 0.052 | 0.006 |
| Emergency conditons | 0.302 | 0.006 | <0.001 |
| Ambulatory surgery | 0.08 | 0.31 | <0.001 |
Values calculated from unique medical record numbers
p value compares Dartmouth with Other Hospitals
NS = not significant
Table 2.
Characteristics of Peripheral Nerve Blocks
| Other Hospitals | Dartmouth | |||
|---|---|---|---|---|
| Characteristic | n | % | n | % |
| Block region | ||||
| Lower extremity | 10,148 | 52.7 | 2,208 | 55.2 |
| Upper extremity | 4,954 | 25.7 | 1,214 | 30.3 |
| Trunk | 3,026 | 15.7 | 515 | 12.9 |
| Paravertebral/lumar plexus | 1,139 | 5.9 | 66 | 1.7 |
| Total | 19,268 | 100 | 4,003 | 100 |
| Technology used | ||||
| Ultrasound alone | 13,708 | 71.1 | 3,908 | 97.6 |
| Ultrasound & Nerve Stimulation | 3,018 | 15.7 | 81 | 2.0 |
| None | 1,560 | 8.1 | 14 | 0.4 |
| Nerve Stimulation alone | 982 | 5.1 | 0 | 0 |
| Total | 19,268 | 100 | 4,003 | 100 |
| Needle type | ||||
| Short bevel | 15,787 | 81.9 | 3,703 | 92.5 |
| Tuohy | 3,008 | 15.6 | 289 | 7.2 |
| Long bevel | 473 | 2.5 | 11 | 0.3 |
| Total | 19,268 | 100 | 4,003 | 100 |
| Block purposeΦ | ||||
| Analgesia | 7,087 | 58.4 | 1,251 | 82.7 |
| Anesthesia & Analgesia | 4,467 | 36.8 | 231 | 15.3 |
| Anesthesia (surgical) | 412 | 3.4 | 27 | 1.8 |
| Diagnostic | 163 | 1.3 | 4 | 0.3 |
| Total | 12,129 | 100 | 1,513 | |
| Block sedation | ||||
| Sedated | 10,122 | 52.5 | 3,370 | 84.2 |
| Awake | 4,121 | 21.4 | 171 | 4.3 |
| General Anesthesia | 5,025 | 26.1 | 462 | 11.5 |
| Total | 19,268 | 100 | 4,003 | 100 |
| AdditiveΦ | ||||
| None | 11,245 | 91.8 | 3,419 | 85.4 |
| Epinephrine | 714 | 5.8 | 60 | 1.5 |
| Dexamethasone | 214 | 1.8 | 461 | 11.5 |
| Clonidine | 70 | 0.6 | 6 | 0.2 |
| Other | 1 | 0.0 | 57 | 1.42 |
| Total | 12,244 | 100 | 4,003 | 100 |
| Local Anesthetic | ||||
| Long action | 17,561 | 91.1 | 3,980 | 99.4 |
| Short acting | 1,707 | 8.9 | 23 | 0.6 |
| Total | 19,268 | 100 | 4,003 | 100 |
| Continuous block | ||||
| Yes | 4,859 | 25.2 | 733 | 18.3 |
| No | 14,409 | 74.8 | 3,270 | 81.7 |
| Total | 19,268 | 100 | 4,003 | 100 |
| Block performed after hours | ||||
| No | 16,550 | 85.9 | 3,991 | 99.7 |
| Yes | 2,718 | 14.1 | 12 | 0.3 |
| Total | 19,268 | 100 | 4,003 | 100 |
Variable only tracked for limited dates
Assessment of Regional Anesthesia at Dartmouth Hitchcock Medical Center
Regional anesthesia safety
Overall, serious complications were rare at DHMC and comparable to those seen at the other IRORA institutions (Table 3). There were no seizures, cardiac arrests, or block related infections at DHMC. Dartmouth reported 20 cases (0.52%) of all cause postoperative neurological sequelae whereas the remainder of the registry reported 154 cases (0.89%), (P value 0.02). Figure 1 depicts cross-sectional comparisons between hospitals for both immediate and PACU complications.
Table 3.
Quality and Morbidity Associated with Regional Blocks
| Other Hospitals | Dartmouth | p value | ||||
|---|---|---|---|---|---|---|
| N = 19,268 | N = 4,003 | |||||
| n | % | n | % | |||
| Immediate EventsΨ | ||||||
| Local anesthetic toxicity (mild) | 7 | 0.04 | 0 | 0 | NS | |
| Local anesthetic toxicity (severe) | 3 | 0.02 | 0 | 0 | NS | |
| Hematoma (localized) | 24 | 0.12 | 2 | 0.05 | NS | |
| Arterial puncture | 91 | 0.47 | 11 | 0.27 | NS | |
| Respiratory depression | 3 | 0.02 | 0 | 0 | NS | |
| Pneumothorax° | 1 | 0.03 | 0 | 0 | NS | |
| Paresthesia/dysesthesia | 192 | 1 | 34 | 0.85 | NS | |
| Wrong site block | 7 | 0.04 | 0 | 0 | NS | |
| Intraneuronal injection | 12 | 0.06 | 1 | 0.02 | NS | |
| Horner’s syndrome | 39 | 0.20 | 11 | 0.27 | NS | |
| Shortness of breath (mild) | 15 | 0.08 | 5 | 0.12 | NS | |
| Shortness of breath (severe) | 4 | 0.02 | 0 | 0 | NS | |
| Retroperitoneal bleeding⌘ | 1 | 0.02 | 0 | 0 | NS | |
| Cardiac arrest | 0 | 0 | 0 | 0 | NS | |
| Death | 0 | 0 | 0 | 0 | NS | |
| Unintentional removal of catheter♦ | 17 | 0.35 | 4 | 0.55 | NS | |
| Other | 32 | 0.17 | 2 | 0.05 | NS | |
| Overall | 451 | 2.34 | 71 | 1.77 | 0.03 | |
| PACU EventsΩ* | ||||||
| Local anesthetic toxicity (mild) | 3 | 0.03 | 0 | 0 | NS | |
| Hematoma | 3 | 0.03 | 1 | 0.06 | NS | |
| Cardiac arrest | 0 | 0 | 0 | 0 | NS | |
| Death | 0 | 0 | 0 | 0 | NS | |
| Cardiovascular instability | 14 | 0.14 | 2 | 0.13 | NS | |
| Shortness of breath (mild) | 12 | 0.12 | 3 | 0.19 | NS | |
| Shortness of breath (severe) | 3 | 0.03 | 0 | 0 | NS | |
| Hoarseness | 7 | 0.07 | 2 | 0.13 | NS | |
| Horner’s syndrome | 8 | 0.08 | 3 | 0.19 | NS | |
| Pneumothorax° | 1 | 0.03 | 1 | 0.09 | NS | |
| Overall | 51 | 0.51 | 12 | 0.77 | NS | |
| Delayed Complications* | ||||||
| Neurological dysfunctionΔ | 154 | 0.89 | 20 | 0.52 | NS | |
| Block related infection | 2 | 0.01 | 0 | 0 | NS | |
| Block Quality | ||||||
| Any opioid medication * | 3,980 | 29.76 | 987 | 46.38 | <0.001 | |
| VAS above 5* | 2,984 | 23.2 | 732 | 35.1 | <0.001 | |
| Block success | 18,545 | 96.0 | 3,969 | 99.1 | <0.001 | |
| Rapid discharge (≤ 30 min)* | 6,147 | 47.97 | 334 | 15.57 | <0.001 | |
Immediate complications were defined as complications identified around time of block insertion and monitoring
Rate based on total blocks that could possibly cause pneumothorax (e.g. interscalene), n= 1,103 for Dartmouth and n= 3,419 for registry
Rate based on total blocks that could possibly cause retroperitoneal bleeding (e.g. lumbar plexus), n= 624 for Dartmouth and n= 4,951 for registry
Post Anesthesia Care Unit (PACU) complications occurred or were noted in the recovery room. Rates were based on a limited sample of N=9,809 for Other Hospitals and N=1,559 for Dartmouth.
Based on patients with continuous blocks, n= 733 for Darmtouth and n= 4,859 for other hospitals
Rate based on unique surgical procedures, (e.g. a femoral and sciatic block for an ankle arthrodesis was analyzed as a single event for the ankle surgery)
Defined as all cause neurological sequelae present at 60 days postoperatively
Figure 1.
Immediate (A) and PACU (B) complication rates. Regional anesthesia procedures (number of complications per 100) ranked in order from low to high across International Registry of Regional Anesthesia member institutions. Abbreviations: DHMC, Dartmouth Hitchcock Medical Center; PACU, Post Anesthesia Care Unit. The Immediate complication rates were based on the entire data set of blocks. PACU complication rates were based on unique surgical procedures.
Regional anesthesia effectiveness
The average highest VAS score in the PACU for DHMC was 1.0 higher than for the remainder (3.0 versus 2.0, 95% CI, for difference of 0.9–1.2, P < 0.001). This corresponded to a higher proportion of patients at DHMC (35.1%) reporting a VAS score of 5 or higher compared to 23.2% of the remainder (P < 0.001). These outcomes are summarized in Table 3 and Figure 2. The occurrence of high VAS scores was demonstrated to be in statistical control, with no evidence for special cause variation (Fig. 3). DHMC experienced a low block failure rate of 1% compared to 4% for other institutions (P < 0.001). Patients at DHMC had a very low rate of early discharge from the PACU compared to other institutions (15.6% vs 48.0%, P < 0.001; Table 3). This low rate of rapid discharge is displayed in an analysis of means chart (Appendix 2). Of all 19 hospitals in the registry, DHMC had the highest proportion of patients receiving opioid analgesic medications in the PACU (46.4% vs 29.8%, Figure 2). Opioid administration was also examined using a SPC chart and found to be in statistical control (Fig. 3).
Figure 2.
Distributions of rates of selected outcomes for all International Registry of Regional Anesthesia member institutions. Any complication comprises immediate, Post Anesthesia Care Unit (PACU), and delayed. Abbreviations: DHMC, Dartmouth Hitchcock Medical Center; VAS; visual analog scale; PACU, Post Anesthesia Care Unit.
Figure 3.
Statistical process control charts (P-charts) for DHMC specific performance for percentage of patients experiencing high VAS scores (A) and percentage of patients receiving opioid analgesic medications (B). For both charts, the solid centerline represents the grand mean of the means from the individual institutions and the dashed lines represents the control limits based on approximately three standard deviations above and below the mean of the means. Abbreviations: DHMC, Dartmouth Hitchcock Medical Center; VAS; visual analog scale.
Comparisons adjusted for differences in patient populations
After adjusting for difference in patient population age, sex, BMI, and ASA score, differences remained between DHMC and other hospitals with respect to VAS scores, use of opioid medications, and early PACU discharge. Adjusted VAS scores revealed a 0.8 higher value on a 0 to 10 numeric scale compared to other hospitals (95% CI, 0.7–1.0). Compared with other institutions, patients at DHMC were approximately 80% less likely to be rapidly discharged from the PACU (OR 0.20, 95% CI, 0.18–0.23) and approximately twice as likely to receive opioids in the PACU (OR 1.90, 95% CI, 1.7–2.1). For complications, DHMC was associated with a 25% reduction in the likelihood of having at least one immediate complication (OR 0.75, 95% CI, 0.58–0.97). DHMC had a higher adjusted likelihood of experiencing at least one PACU complication, but this did not reach statistical significance (OR 1.49, 95% CI, 0.78–2.84). DHMC had a 45% reduction in the likelihood of sustaining all cause postoperative neurological sequelae (OR 0.54, 95% CI, 0.34–0.88). Figure 4 reveals the adjusted OR for opioid use, high VAS score, and delayed discharge across the IRORA member institutions.
Figure 4.
Adjusted odds ratios for the association between International Registry of Regional Anesthesia member institutions and various clinical outcomes. DHMC is the reference institution and odds ratios are adjusted for differences in patient population age, sex, body mass index, and American Society of Anesthesiologists health status. abbreviations: DHMC, Dartmouth Hitchcock Medical Center.
DISCUSSION
We have characterized the baseline performance data, regarding both safety and effectiveness, from an international clinical registry of PNB procedures, IRORA and used it to compare and contrast the performance of one reference institution, DHMC. To our knowledge, this is the first study to demonstrate the utility of a clinical registry for informing care improvement related to regional anesthesia. The overall registry performance in regards to all cause postoperative nerve injury falls within the 95% CI of previously reported literature from both DHMC and this registry.9,11 The current analysis reports three cases of LAST in more than 20,000 blocks representing a reduced incidence than previously reported.9
Our reference institution, DHMC, had lower rates of immediate and all cause neurologic sequelae compared with the average of other institutions in the clinical registry. Arguably, many of the tracked complications were minor, such as venous puncture and Horner’s syndrome. When considering serious complications such as cardiac arrest, death, or severe local anesthetic toxicity (seizure), DHMC did not have any events in 4,003 PNBs. With respect to block quality, Dartmouth reported a low failure rate of <1%. Despite this low failure rate, nearly half of the patients having regional anesthesia received supplemental opioid therapy. This high utilization rate of opioids is consistent with the finding that 38% of patients reported having a VAS score of 5 or higher (out of 10). Similarly, a minority of patients were discharged from the PACU within 30 minutes of arrival.
This exercise to review our performance has allowed us to establish a baseline for on-going monthly surveillance and real-time monitoring. We feel that the overall complication rate is acceptable and current performance does not mandate quality improvement activities. However, performance around the pain experience, use of opioid analgesic medications, and discharge efficiency suggests the need to investigate further our processes of perioperative care. Additionally, given that our SPC charts (Fig. 3), demonstrate no special cause signals, such as points above the upper control limits, we can be confident that future performance will likely be similar unless changes are made. Given that PNB success is high, we suspect that our lower performance around pain control may reflect characteristics unique to our nursing and PACU processes independent of the quality of the nerve block. Additionally, we suspect the discrepancy may be partially cultural in origin. Within the registry, DHMC is only one of two hospitals in the US, which leads the world in opioid consumption.12 We plan on conducting detailed process mapping around the microsystems of both the block room and the recovery room. The goal would be to conduct several Plan Do Study Act cycles with the aim of reducing the proportion of patients who experience high pain scores.13 One would logically assume that a reduction in the use of opioid analgesic medications would translate into faster patient discharge. Our preliminary investigation initiated by the results of this study suggest that ambulatory PACU nurses often administer surgeon prescribed opioid analgesic medications for patients even with no pain in an effort to provide analgesia for when the block resolves. This may be a practice to change in order to reduce side effects from the unnecessary opioid administration. The benefit of including the statistical process charts (Fig. 3) is that quality improvement interventions can be converted into a time-series analysis. For example, if an intervention improves performance with a corresponding special cause signal, one can feel confident it is the result of the intervention rather than from chance.14
The apparent discrepancy between the high reported block success rate and the high proportion of VAS scores above 5 for DHMC may reflect several scenarios such as pain outside of the block coverage (eg, sciatic distribution after femoral nerve block for total knee replacement), blocks resolving in the recovery room, over-reporting of success rates by individual operators, or even cultural differences in the reporting of pain. The reason to use multiple overlapping outcome metrics is to ensure an accurate assessment of effectiveness and safety.
Limitations
There are several limitations to our investigation. A clinical registry collects data that is limited in scope and uses defined metrics that are standardized and arguable simplistic in the context of our perioperative care pathways. This facilitates capturing information from a large number of patients. Opioid analgesic medications may be given liberally, independent of the effectiveness of the regional anesthesia; therefore, opioid use is limited as an objective measure of PNB effectiveness. Regardless, we feel that an in depth study of the perioperative pain management processes may result in improvements in clinical care. A further limitation is that some centers or individuals may have potentially under-reported complications or poor outcomes. Therefore, our results may under-estimate the true complication and poor performance rates. To minimize such under reporting IRORA has periodic site visits and data quality assessments and it should be noted that the majority of collaborating hospitals have a culture of reporting incidents.
Future direction
We plan to explore the apparent improved performance at DHMC compared with other hospitals. Examples of improved performance at DHMC are a zero rate of preventable complication such as wrong-site PNB and a reduced rate of postoperative neurological sequelae. Differences in the rate of neurological sequelae may represent unmeasured confounders, such as surgical technique or patient issues and further analysis of this outcome is beyond the scope of this study. Further improvements in the safety of regional anesthesia may be achieved by identifying both processes and structures of care that could be shared by member institutions. Often high-performing centers in clinical registries allow site visits and information sharing to promote the dissemination of high value interventions. Site visits and information sharing among members represents a more granular analysis informed by the aggregated registry data and would potentially highlight reasons for differences in clinical performance.
Conclusions
In summary, we have gained insight into the relative performance of our regional anesthesia practice by using prospective observational data collected by an international clinical registry. We have used both aggregate and time ordered data displayed through traditional and statistical process control charts. With this exercise, we have identified targets for quality improvement and further investigation. Future quality improvement activities will likely identify systems issues and culture characteristics that may not directly relate to the success or failure of the procedure.
Acknowledgements
The authors acknowledge staff and departmental resources provided by collaborating hospitals who have supported this project: Ms Colleen Ward, RN, Dr Myles Conroy MB, BS, FANZCA (Department of Anaesthesia, Geelong Hospital, Geelong, VIC, Australia); Dr Elizabeth Bashford, MB, BS, FANZCA (Department of Anaesthesia, Ballarat Base Hospital, Ballarat, VIC, Australia); Mr Richard Craig, Ms Margie McKellow, Dr Alex Baker MB, BS, FANZCA (Department of Anaesthesia Christchurch Hospital, New Zealand); Dr Ellen Seiffert MD, Wendy Boardman (Department of Anesthesiology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA); Dr David Scott, MB, BS, FANZCA, Dr Dougall Miller MB, BS, FANZCA., Dr Andrew Peart, MB, BS, FANZCA, Dr Bryan Cook, MB, BS, FANZC, Ms Susan Shaw RN (Department of Anaesthesia, Lismore Base Hospital, Northern Rivers Anaesthesia Services, Lismore, NSW); Dr Hou Yee Lai MB, BS, M.Anaes. (Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia); Dr Kelly Byrne Ch.B., F.A.N.Z.C.A. (Department of Anaesthesia, Waikato Hospital, New Zealand); Dr David Pirotta, MB, BS, FANZCA. (Department of Anaesthesia, Wellington Hospital, Wellington, New Zealand); Dr Marco Meijer MB, BS, FANZCA. (Department of Anaesthesia, Wanganui Hospital, New Zealand); Dr Simon Pattullo MB, BS, FANZCA, Dr Halia O’Shea MB, BS, FANZCA., Dr Greg Masterton MB, BS, FANZCA (Department of Anaesthesia, Gold Coast Hospital, QLD, Australia); Dr David Bellavy, Dr Adrian Chin MB, BS, FANZCA. (Department of Anaesthesia, Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia); Dr Andrew Fenton, MB, BS, FANZCA, Dr Keen Cheah, MB, BS, FANZCA, Ms Jennifer Phillips (Department of Anaesthesia, Royal Darwin Hospital, NT, Australia); Mr Matt Watson BMedSci, Ms Sania El-Najjar B.Sci. (Department of Anaesthesia, St Vincent’s Hospital, Melbourne); Dr Phillip Cowlishaw, MB, BS, FANZCA, Leanne Gleeson RN (Department of Anaesthesia, Mater Adult Hospital, Brisbane, QLD, Australia); Dr Jarrod Ngan, MB, BS, FANZCA, Dr Pal Sivalingam, MB, BS, FANZCA., Catherine Jowett, RN (Department of Anaesthesia, Princess Alexandra Hospital, Brisbane, QLD, Australia); Dr Geoffrey Crawford MB, BS, FANZCA. (Department of Anaesthesia, Logan Hospital, Brisbane, QLD, Australia); Dr Jonathan Weed M.D. (Department of Anesthesiology, Tulane University Medical Center, New Orleans, LA, USA).
Funding:
MJB acknowledges financial support from the Australian and New Zealand College of Anaesthetists in the form of scholarship (10/023) and project (14/030) grants.
Appendix 1: IRORA Hospitals
| Hospital Name | Bed number | Teaching Status |
|---|---|---|
| Ballarat Hospital | 220 | Yes |
| Christchurch Hospital | 650 | Yes |
| Dartmouth Hitchcock Medical Center | 388 | Yes |
| Geelong Hospital | 406 | Yes |
| Gold Coast Hospital | 500 | Yes |
| John Flynn Hospital | 326 | Yes |
| Lismore Base Hospital | 250 | No |
| Logan Hospital | 316 | Yes |
| Mater Adult Hospital | 126 | Yes |
| Princess Alexandra Hospital | 650 | Yes |
| Royal Brisbane and Women's Hospital | 929 | Yes |
| Royal Darwin Hospital | 363 | Yes |
| St. Vincent's Private Hospital, Melbourne | 500 | Yes |
| St. Vincent’s Hospital, Melbourne | 350 | Yes |
| Tulane University Medical Center | 365 | Yes |
| University Malaya Medical Centre | 1109 | Yes |
| Waikato Hospital | 600 | Yes |
| Wanganui Hospital | 250 | No |
| Wellington Hospital | 400 | Yes |
Appendix 2
Analysis of Means chart for the entire International Registry of Regional Anesthesia clinical registry for rapid discharge following regional anesthesia. The solid line depicts the collective grand mean of all 19-member institutions and bars indicate how much above or below the mean each institution is performing. The control limits are calculated based on the numerator and denominator and represent an alpha of 1%.
Footnotes
Attribution:
This work should be credited to: International Registry of Regional Anesthesiology (IRORA).
Conflict of Interest:
The authors declare no conflict of interest.
REFERENCES
- 1.Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg. 2002;94:65–70. doi: 10.1097/00000539-200201000-00012. [DOI] [PubMed] [Google Scholar]
- 2.Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002;96:1297–1304. doi: 10.1097/00000542-200206000-00006. [DOI] [PubMed] [Google Scholar]
- 3.Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002;97:959–965. doi: 10.1097/00000542-200210000-00031. [DOI] [PubMed] [Google Scholar]
- 4.Ilfeld BM, Morey TE, Wright TW, Chidgey LK, Enneking FK. Continuous interscalene brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 2003;96:1089–1095. doi: 10.1213/01.ANE.0000049824.51036.EF. [DOI] [PubMed] [Google Scholar]
- 5.Faccenda KA, Finucane BT. Complications of regional anaesthesia Incidence and prevention. Drug Saf. 2001;24:413–442. doi: 10.2165/00002018-200124060-00002. [DOI] [PubMed] [Google Scholar]
- 6.Orebaugh SL, Kentor ML, Williams BA. Adverse outcomes associated with nerve stimulator-guided and ultrasound-guided peripheral nerve blocks by supervised trainees: update of a single-site database. Reg Anesth Pain Med. 2012;37:577–582. doi: 10.1097/AAP.0b013e318263d396. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Marissa G, Vadi M, Patel N, Stiegler P. Case Scenario: Local Anesthetic Systemic Toxicity after Combined Psoas Compartment-Sciatic Nerve Block Analysis of Decision Factors and Diagnostic Delay. Anesthesiology. 2014;120:987–996. doi: 10.1097/ALN.0000000000000154. [DOI] [PubMed] [Google Scholar]
- 8.Fisher E, Shortell S. Accountable care Organizations. accountable for what, to whom, and how. JAMA. 2010;304:1715–1716. doi: 10.1001/jama.2010.1513. [DOI] [PubMed] [Google Scholar]
- 9.Barrington MJ, Watts SA, Gledhill SR, et al. Preliminary results of the Australaian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Reg Anesth Pain Med. 2009;34:534–541. doi: 10.1097/aap.0b013e3181ae72e8. [DOI] [PubMed] [Google Scholar]
- 10.Thor J, Lundberg J, Ask J, Olsson J, Carli C, Pukk Härenstam K, Brommels M. Application of statistical process control in healthcare improvement: systematic review. Qual Saf Health Care. 2007;16:387–399. doi: 10.1136/qshc.2006.022194. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Sites BD, Taenzer AH, Herrick MD, Antonakakis J, Richins J, Beach ML. Incidence of local anesthetic systemic toxicity and postoperative neurologic symptoms associated with 12,668 ultrasound-guided nerve blocks: an analysis from a prospective clinical registry. Reg Anesth Pain Med. 2012;37:478–482. doi: 10.1097/AAP.0b013e31825cb3d6. [DOI] [PubMed] [Google Scholar]
- 12.Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician. 2008;11:S63–S88. [PubMed] [Google Scholar]
- 13.Taylor M, McNicholas C, Nicolay C, Darzi A, Bell D, Reed J. Systematic review of the application of the plan-do-study-act method to improve quality in healthcare. BMJ Quality Saf. 2014;23:290–298. doi: 10.1136/bmjqs-2013-001862. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Sedlack JD. The utilization of six sigma and statistical process control techniques in surgical quality improvement. J Healthc Qual. 2010;32:18–26. doi: 10.1111/j.1945-1474.2010.00102.x. [DOI] [PubMed] [Google Scholar]





