American Society of Anesthesiologists Physical Status Classification as a reliable predictor of postoperative medical complications and mortality following ambulatory surgery: an analysis of 2,089,830 ACS-NSQIP outpatient cases.

BACKGROUND: Seventy percent of surgical procedures are currently performed in the outpatient setting. Although the American Society of Anesthesiologists (ASA) Physical Classification ability to predict risk has been evaluated for in-patient surgeries, an evaluation in outpatient surgeries has yet to be performed. The major goal of the current study is to determine if the ASA classification is an independent predictor for morbidity and mortality for outpatient surgeries. METHODS: The 2005 through 2016 NSQIP Participant Use Data Files were queried to extract all patients scheduled for outpatient surgery. ASA PS class was the primary independent variable of interest. The primary outcome was 30-day medical complications, defined as having one or more of the following postoperative outcomes: (1) deep vein thrombosis, (2) pulmonary embolism, (3) reintubation, (4) failure to wean from ventilator, (5) renal insufficiency, (6) renal failure, (7) stroke, (8) cardiac arrest, (9) myocardial infarction, (10) pneumonia, (11) urinary tract infection, (12) systemic sepsis or septic shock. Mortality was also evaluated as a separate outcome. RESULTS: A total of 2,089,830 cases were included in the study. 24,777 (1.19%) patients had medical complications and 1,701 (0.08%) died within 30 days. ASA PS IV patients had a much greater chance of dying when compared to healthy patients, OR (95%CI) of 89 (55 to 143), P < 0.001. Nonetheless, over 30,000 ASA PS IV patients had surgery in the outpatient setting. Multivariable analysis demonstrated a stepwise independent association between ASA PS class and medical complications (C statistic = 0.70), mortality (C statistic = 0.74) and readmissions (C statistic = 0.67). Risk stratifying ability was maintained across surgical procedures and anesthesia techniques. CONCLUSIONS: ASA PS class is a simple risk stratification tool for surgeries in the outpatient setting. Patients with higher ASA PS classes subsequently developed medical complications or mortality at a greater frequency than patients with lower ASA PS class after outpatient surgery. Our results suggest that the ambulatory setting may not be able to match the needs of high-risk patients.

An evaluation of impact factor bias of clinical trials published in pain journals.

BACKGROUND AND OBJECTIVE: Studies with nonsignificant results are less likely to be published or published in lower impact factor journals. To determine whether a similar phenomenon occurs in pain literature, we explored impact factor bias in peer-reviewed pain journals. METHODS: A PubMed search involving randomized controlled trials in pain journals during 2012 through 2018 was performed. The primary outcome was the publication impact factor. Exclusion criteria included commentaries, editorials, meta-analyses, reviews, and animal studies. The average impact factor for each journal was determined. The primary independent variable was a study with a positive outcome. RESULTS: Of the 9 journals evaluated, 1108 articles met our inclusion criteria and were included in our analysis. The quartiles for the impact factor for the journals included were 2.5, 2.9, and 3.6. A multivariate analysis identified sample size greater than 100, description of a sample size calculation, presence of a stated hypothesis, and presence of sponsorship funding as independent predictors of publication in a journal with greater impact factor. In contrast, positive results were not associated with publication in a greater impact factor journal, even when forced into the model, P = 0.49. CONCLUSIONS: After adjusting for study factors associated with publication, there is no evidence of impact factor bias within the pain literature. The lack of impact factor bias in the pain literature is a positive finding for the field and should benefit scientific development and the clinical care of patients.

The association between labor epidural analgesia and postpartum depression: a systematic review and meta-analysis.

BACKGROUND: Previous studies have demonstrated that appropriate treatment for postoperative pain can lead to improvement in depressive symptoms, however the association between adequate intrapartum pain control and the development of postpartum depression is not clear. The purpose of the study was to examine the effects of labor epidural analgesia and postpartum depression. METHODS: We performed a quantitative systematic review in compliance with the PRISMA statement. We conducted a search of PubMed, Embase, the Cochrane Database of Systematic Reviews and Google Scholar databases. The primary outcome was a positive screen of postpartum depression among women who received labor epidural analgesia up to 3 months into the postpartum period. Meta-analysis was performed using the random effect model. RESULTS: Of the 148 studies available, 9 studies with 4442 patients were included in the analysis. The use of labor analgesia on positive depression screen compared to control revealed no significant effect, OR (95% CI) of 1.02 (0.62 to 1.66, P = 0.94). CONCLUSION: Based on current literature, the use of epidural analgesia for pain relief during labor doesn't appear to affect the likelihood of postpartum depression. Future studies are warranted to further investigate these findings and identity other possible preventative interventions that reduce postpartum depression.

The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials.

BACKGROUND: The effect of erector spinae plane block has been evaluated by clinical trials leading to a diversity of results. The main objective of the current investigation is to compare the analgesic efficacy of erector spinae plane block to no block intervention in patients undergoing surgical procedures. METHODS: We performed a quantitative systematic review of randomized controlled trials in PubMed, Embase, Cochrane Library, and Google Scholar electronic databases from their inception through July 2019. Included trials reported either on opioid consumption or pain scores as postoperative pain outcomes. Methodological quality of included studies was evaluated using Cochrane Collaboration's tool. RESULTS: Thirteen randomized controlled trials evaluating 679 patients across different surgical procedures were included. The aggregated effect of erector spinae plane block on postoperative opioid consumption revealed a significant effect, weighted mean difference of - 8.84 (95% CI: - 12.54 to - 5.14), (P < 0.001) IV mg morphine equivalents. The effect of erector spinae plane block on post surgical pain at 6 h compared to control revealed a significant effect weighted mean difference of - 1.31 (95% CI: - 2.40 to - 0.23), P < 0.02. At 12 h, the weighted mean difference was of - 0.46 (95% CI: - 1.01 to 0.09), P = 0.10. No block related complications were reported. CONCLUSIONS: Our results provide moderate quality evidence that erector spinae plane block is an effective strategy to improve postsurgical analgesia.

Predictive factors for adverse outcomes in pediatric patients undergoing low-risk skin and soft tissue surgery: A database analysis of 6730 patients.

BACKGROUND: There is a paucity of data regarding risk stratification of pediatric patients presenting for low-risk skin and soft tissue surgery. AIMS: We sought to determine the incidence and independent predictors of postoperative complications and unplanned 30-day readmission in a cohort of children undergoing low-risk skin and soft tissue surgery. METHODS: The study included pediatric patients who underwent minor procedures of the skin and soft tissue at continuously enrolled American College of Surgeons National Surgical Quality Improvement Program Pediatric hospitals over a two-year period. The primary outcome was a 30-day postoperative complication composite. The secondary outcome was unplanned 30-day readmission. RESULTS: The final analysis included 6,730 patients. There were a total of 170 postoperative complications among 152 patients (2.23%) with the majority of complications being either wound-related or postoperative mechanical ventilation. The independent predictors for an increased risk of postoperative complication were American Society of Anesthesiologists classification ≥3 and nutritional deficiency. There were 41 unplanned readmissions (0.61%). The presence of a postoperative wound complication or a postoperative pulmonary complication during the index hospital stay was an independent risk factor for unplanned 30-day readmission. CONCLUSION: Pediatric patients with American Society of Anesthesiologists classification ≥3 and nutritional deficiency undergoing low-risk surgery are at risk for the development of postoperative complications. Patients who develop wound and postoperative pulmonary complications are at higher risk for unplanned 30-day readmission. Identification of these higher risk patients may allow the anesthesiologist to implement targeted therapies to minimize the likelihood of occurrence of these complications.

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P < .05 was used to reject the null hypothesis for the primary outcome. Seventy subjects were randomized and sixty-five completed the study. Patients' baseline characteristics and surgical factors were similar between the study groups. There was a clinically significant difference in the global QoR-40 scores between the acetaminophen and the saline groups, median (IQR) of 189 (183 to 194) and 183 (175 to 190), respectively, P = .01. In addition, there was an inverse relationship (Spearman's rho= -0.33) between oral opioid consumption at home (oral morphine equivalents) and 24 hour postoperative quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery.

The impact of health literacy on shared decision making before elective surgery: a propensity matched case control analysis.

BACKGROUND: Poor health literacy affects over 90 million Americans. The primary aim of the study was to evaluate a possible association between health literacy and decision conflict in surgical patients. METHODS: Patients undergoing a diverse number of elective surgeries were enrolled in the study. Health literacy was measured using the Newest Vital Sign instrument and decision conflict using the low literacy version of the Decision Conflict Scale. RESULTS: 200 patients undergoing elective surgeries were included in the study. Patients who had greater health literacy scores had lower decision conflict scores, Spearman's rho = - 0.43, P < 0.001. Following propensity-score matching to account for potential covariates, the median (IQR) decision conflict score was 20 (0 to 40) for patients with poor health literacy compared to 0 (0 to 5) for patients with adequate literacy, P < 0.001. CONCLUSIONS: Poor health literacy is associated with greater decision conflict in patients undergoing elective surgical procedures. Strategies should be implemented to minimize decision conflict in poor health literacy patients undergoing elective surgical procedures.

Demystifying the "July Effect" in Plastic Surgery: A Multi-Institutional Study.

BACKGROUND: The "July Effect" refers to a theoretical increase in complications that may occur with the influx of inexperienced interns and residents at the beginning of each academic year in July. OBJECTIVES: We endeavored to determine if a July Effect occurs in plastic surgery. METHODS: Plastic surgery procedures were isolated from the National Surgical Quality Improvement Program registry. Cases involving residents were grouped as either having occurred within the first academic quarter (AQ1) or remaining year (AQ2-4). Groups were propensity matched using patient/operative factors and procedure type to account for baseline differences. Univariate and multivariate regression analyses assessed differences in overall complications, surgical and medical complications, individual complications, length of hospital stay, and operative time. A comparison group comprised of procedures without resident involvement was also analyzed. RESULTS: There were 5967 cases with resident involvement, 5156 of which successfully matched. Both univariate and multivariate regression analyses revealed no significant differences between AQ1 and AQ2-4 in terms of overall, surgical, medical and individual complications, or length of hospital stay. There was a statistically significant, albeit not clinically significant, increase in operative time by 10 minutes per procedure during AQ1 in comparison to AQ2-4 (P = 0.001). For procedures lacking resident participation, there were no differences between AQ1 and AQ2-4 in terms of these outcomes. CONCLUSIONS: A July Effect was not observed for plastic surgery procedures in our study, conceivably due to enhanced resident oversight and infrastructural safeguards. Patients electing to undergo plastic surgery early in the academic year can be reassured of their safety during this period.

The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: To compare the incidence in postsurgical persistent pain following breast cancer surgery in women receiving intravenous lidocaine compared to saline using validated pain instruments in accordance with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations. METHODS: The study was a randomized, double-blinded, placebo-controlled, clinical trial. Subjects were randomized into Group 1 (1.5 mg/kg bolus of intravenous lidocaine followed by a 2 mg/kg/hour infusion) or Group 2 (normal saline at the same bolus and infusion rate). Patients were evaluated at 3 and 6 months for the presence of chronic persistent postsurgical pain. RESULTS: One hundred forty-eight patients were included in the study analysis. There were no differences in quality of recovery, pain burden, or opioid consumption between groups at 24 hours. Pain (yes/no) at 6 months attributed to surgery was reported in 29% of Group 2 vs. 13% of Group 1 patients (P = 0.04); however, only 3 subjects (5%) in Group 1 and 2 subjects (3%) in Group 2 met IMMPACT criteria for persistent postoperative pain (P = 0.99). DISCUSSION: Perioperative infusion of lidocaine has been reported to decrease the incidence of postsurgical pain at 3 and 6 months following mastectomy using dichotomous (yes/no) scoring. Although intravenous lidocaine reduced the reported incidence of pain at rest at 6 months, pain with activity, pain qualities, and the physical or emotional impact of the pain were unaffected. Future studies evaluating postsurgical persistent pain should adhere to the IMMPACT recommendations in order to more accurately describe the effect of an intervention on persistent pain.

Blood Bupivacaine Concentrations After a Combined Single-Shot Sciatic Block and a Continuous Femoral Nerve Block in Pediatric Patients: A Prospective Observational Study.

We evaluated blood bupivacaine concentrations in children having a single-shot sciatic and continuous femoral blocks after anterior cruciate ligament repair. Dried blood spot samples were analyzed for bupivacaine levels at 0, 5, 15, 30, 60, and 120 minutes and 4, 24, and 48 hours. The highest 99% upper confidence interval limit was 135 ng/mL at the 4-hour evaluation point. The 99% upper confidence interval was below potentially toxic levels (1500 ng/mL) across all sampling times. The risk of local anesthetic toxicity in pediatric patients receiving single-shot sciatic and continuous femoral nerve blocks is very low.

Unplanned, Postoperative Intubation in Pediatric Surgical Patients: Development and Validation of a Multivariable Prediction Model.

BACKGROUND: To date, the independent predictors and outcomes of unplanned postoperative intubation (UPI) in pediatric patients after noncardiac surgery are yet to be characterized. The authors aimed to identify the incidence and predictors of this event and evaluated the effect of this event on postoperative mortality. METHODS: Data of 87,920 patients from the American College of Surgeons National Surgical Quality Improvement Program Pediatric database were analyzed and assigned to derivation (n = 58,614; 66.7%) or validation (n = 29,306; 33.3%) cohorts. The derivation cohort was analyzed for the incidence and independent predictors of early UPI. The final multivariable logistic regression model was validated using the validation cohort. RESULTS: Early UPI occurred with an incidence of 0.2% in both cohorts. Among the 540 patients who experienced a UPI, 178 (33.0%) were intubated within the first 72 h after surgery. The final logistic regression model indicated operation time, severe cardiac risk factors, American Society of Anesthesiologists physical status classification more than or equal to 2, tumor involving the central nervous system, developmental delay/impaired cognitive function, past or current malignancy, and neonate status as independent predictors of early UPI. Having an early UPI was associated with an increased risk of unadjusted, all-cause 30-day mortality, demonstrating an odds ratio of 11.4 (95% CI, 5.8 to 22.4). CONCLUSIONS: Pediatric patients who experienced an early UPI after noncardiac surgery had an increased likelihood of unadjusted 30-day mortality by more than 11-fold. Identification of high-risk patients can allow for targeted intervention and potential prevention of such outcomes.

Blood Bupivacaine Concentrations After Transversus Abdominis Plane Block in Neonates: A Prospective Observational Study.

BACKGROUND: Untreated pain can have instant and prolonged consequences to behavioral and neurologic outcomes in neonates. Although the use of transversus abdominis plane (TAP) block to minimize postsurgical pain has been demonstrated in neonates, no data regarding the safety of this procedure are available for this patient population. For instance, it is unknown whether plasma levels of local anesthetics are safe in neonates after TAP blocks. The main objective of the current investigation was to evaluate plasma bupivacaine concentrations in neonates having an ultrasound-guided TAP block. METHODS: The study was a prospective, observational study. After general anesthesia was induced, neonates received an ultrasound-guided TAP block with 0.125% bupivacaine and a total volume of 1 mL/kg. Dried blood spot samples were obtained and analyzed for bupivacaine levels at 0, 5, 15, 30, 60, 120 minutes, 4, and 24 hours after the TAP block. RESULTS: Ten neonates were included in the study. The highest 99% upper prediction limit for blood concentration, 0.38 µg/mL, occurred at the 30-minute interval, but it was significantly lower than potentially toxic plasma levels (1.5-2.0 µg/mL). The highest individual concentration was 0.26 µg/mL and occurred at the 30-minute interval. None of the patients demonstrated any potential signs of local anesthetic toxicity. CONCLUSIONS: Our results suggest a low risk of local anesthetic toxicity in neonates after a TAP block. Future studies to determine the efficacy of the TAP block to minimize postsurgical pain in this patient population are warranted.

The Use of Neuraxial Catheters for Postoperative Analgesia in Neonates: A Multicenter Safety Analysis from the Pediatric Regional Anesthesia Network.

BACKGROUND: Currently, there is limited evidence to support the safety of neuraxial catheters in neonates. Safety concerns have been cited as a major barrier to performing large randomized trials in this population. The main objective of this study is to examine the safety of neuraxial catheters in neonates across multiple institutions. Specifically, we sought to determine the incidence of overall and individual complications encountered when neuraxial catheters were used for postoperative analgesia in neonates. METHODS: This was an observational study that used the Pediatric Regional Anesthesia Network database. Complications and adverse events were defined by the presence of at least 1 of the following intraoperative and/or postoperative factors: catheter malfunction (dislodgment/occlusion), infection, block abandoned (unable to place), block failure (no evidence of block), vascular (blood aspiration/hematoma), local anesthetic systemic toxicity, excessive motor block, paresthesia, persistent neurologic deficit, and other (e.g., intra-abdominal misplacement, tremors). Additional analyses were performed to identify the use of potentially toxic doses of local anesthetics. RESULTS: The study cohort included 307 neonates with a neuraxial catheter. There were 41 adverse events and complications recorded, resulting in an overall incidence of complications of 13.3% (95% confidence interval, 9.8%-17.4%). Among the complications, catheter malfunction, catheter contamination, and vascular puncture were common. None of the complications resulted in long-term complications and/or sequelae, resulting in an estimated incidence of any serious complications of 0.3% (95% confidence interval, 0.08%-1.8%). There were 120 of 307 patients who received intraoperative and/or postoperative infusions consistent with a potentially toxic local anesthetic dose in neonates. The incidence of potentially toxic local anesthetic infusion rates increased over time (P = 0.008). CONCLUSIONS: Neuraxial catheter techniques for intraoperative and postoperative analgesia appear to be safe in neonates. Further studies to confirm our results and to establish the efficacy of these techniques across different surgical procedures are required. We suggest that each center that uses neuraxial anesthesia techniques in neonates closely evaluate the dose limits for local anesthetic agents and develop rigorous quality assurance methods to ensure potentially toxic doses are not used.

Perioperative Duloxetine to Improve Postoperative Recovery After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.

BACKGROUND: Postsurgical quality of recovery is worse in female than that in male patients. Duloxetine has been used successfully for the treatment of chronic pain conditions, but its use for preventing acute postoperative pain has been limited to a single previous study. More importantly, the effect of preoperative duloxetine on global postoperative quality of recovery has yet to be evaluated. The main objective of the current investigation was to evaluate the effect of perioperative duloxetine on postoperative quality of recovery in women undergoing abdominal hysterectomy. METHODS: The study was a prospective, randomized, placebo-controlled, double-blinded trial. Female patients undergoing abdominal hysterectomy were randomized to receive duloxetine (60 mg orally 2 hours before surgery and 24 hours after surgery) or an identical placebo pill. The primary outcome was the quality of recovery-40 score at 24 hours. Secondary outcomes included opioid consumption and postoperative pain scores. A P value <0.05 was used to reject type I error. RESULTS: Seventy patients were recruited, and 63 completed the study. The median difference (95% confidence interval) in global recovery scores (quality of recovery-40) at 24 hours after surgery between the duloxetine and the placebo group was 9 (4-20) (P < 0.001). Total opioid consumption was reduced at 24 hours in the duloxetine group compared with the placebo group, median (interquartile range) of 1 (0-5) mg IV morphine compared with 5.5 (0.5-9) mg IV morphine (P = 0.004). Nausea, vomiting, and time to postanesthesia care unit discharge were not significantly reduced in the duloxetine group compared with placebo. CONCLUSIONS: Duloxetine improves postoperative quality of recovery after abdominal hysterectomy. In addition, duloxetine reduces postoperative opioid consumption, even in the presence of a robust multimodal analgesic strategy. Duloxetine seems to be a viable pharmacologic strategy to improve postoperative quality of recovery in female patients undergoing abdominal hysterectomy.

Sustainability of protocolized handover of pediatric cardiac surgery patients to the intensive care unit.

BACKGROUND: Transfer of patient care among clinicians (handovers) is a common source of medical errors. While the immediate efficacy of these initiatives is well documented, sustainability of practice changes that results in better processes of care is largely understudied. AIMS: The objective of the current investigation was to evaluate the sustainability of a protocolized handover process in pediatric patients from the operating room after cardiac surgery to the intensive care unit. METHODS: This was a prospective study with direct observation assessment of handover performance conducted in the cardiac ICU (CICU) of a free-standing, tertiary care children's hospital in the United States. Patient transitions from the operating room to the CICU, including the verbal handoff, were directly observed by a single independent observer in all phases of the study. A checklist of key elements identified errors classified as: (1) technical, (2) information omissions, and (3) realized errors. Total number of errors was compared across the different times of the study (preintervention, postintervention, and the current sustainability phase). RESULTS: A total of 119 handovers were studied: 41 preintervention, 38 postintervention, and 40 in the current sustainability phase. The median [Interquartile range (IQR)] number of technical errors was significantly reduced in the sustainability phase compared to the preintervention and postintervention phase, 2 (1-3), 6 (5-7), and 2.5 (2-4), respectively P = 0.0001. Similarly, the median (IQR) number of verbal information omissions was also significantly reduced in the sustainability phase compared to the preintervention and postintervention phases, 1 (1-1), 4 (3-5) and 2 (1-3), respectively. CONCLUSIONS: We demonstrate sustainability of an improved handover process using a checklist in children being transferred to the intensive care unit after cardiac surgery. Standardized handover processes can be a sustainable strategy to improve patient safety after pediatric cardiac surgery.

The relationship between the Bispectral Index (BIS) and the Observer Alertness of Sedation Scale (OASS) scores during propofol sedation with and without ketamine: a randomized, double blinded, placebo controlled clinical trial.

Prior studies have examined the static effect of intravenous ketamine on the BIS Index for sedation but it remains unknown if the BIS Index is a reliable method to track sedation levels in the presence of ketamine. The major objective of the current investigation was to compare the BIS Vista Index ability to track varying depths of sedation as determined by OASS scores in a standardized anesthetic regimen with and without ketamine. The study was a randomized, double blinded clinical trial. Patients undergoing breast surgery under sedation with propofol were randomized to receive ketamine (1.5 µg kg min(-1)) or saline. Infusion data was used to estimate propofol plasma concentrations (Cp). The main outcome of interest was the correlation between the BIS Vista Index with the OASS score. Twenty subjects were recruited and fifteen completed the study. Four hundred fifty-five paired data points were included in the analysis. Model performance (Nagelkerke R(2)) of the multinomial logistic regression model was 0.57 with the c-statistic of 0.87 (95 % CI 0.82-0.91). Compared to awake the odds ratio for BIS values predicting moderate sedation in the saline/propofol group 1.19 (95 % CI 1.12-1.25) but only 1.06 (95 % CI 1.02-1.1) in the ketamine/propofol group (P = 0.001). There was no difference in the odds for BIS values to predict deep sedation between groups (P = 0.14). The BIS monitor can be used to monitor sedation level even when ketamine is used with propofol as part of the sedation regimen. However, ketamine reduces the value of the BIS in predicting moderate sedation levels.

Discrepancies Between Randomized Controlled Trial Registry Entries and Content of Corresponding Manuscripts Reported in Anesthesiology Journals.

BACKGROUND: Clinical trial registries have been created to reduce reporting bias. Study registration enables the examination of discrepancies between the original study design and the final results reported in the literature. The main objective of the current investigation is to compare the original clinical trial registrations and the corresponding published results in high-impact anesthesiology journals. Specifically, we examined the rates of major discrepancies (i.e., involving primary outcome, sample size calculation, or study intervention). METHODS: The 5 highest-impact factor anesthesiology journals (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, and Regional Anesthesia and Pain Medicine) were screened for randomized controlled trials published in 2013. A major discrepancy was defined as a difference in the content of the manuscript compared with the original entry in a clinical trial registry for at least one of the 3 areas: primary outcome, target sample size, and study intervention. The type of primary outcome discrepancy was further classified as adding/omitting measures or outcomes, downgrading/upgrading from primary to secondary outcomes, or changing the definition of the outcomes measured. RESULTS: Two hundred one articles were included in the final analysis. One hundred thirty of 201 (64%; 95% confidence interval [CI], 57%-71%) published clinical trials were not prospectively registered as recommended by the International Committee of Medical Journal Editors. Registration rates were significantly lower between studies performed in the United States, 15 of 40 (37%), compared with studies not performed in the United States, 92 of 161 (57%), P = 0.03. Fifty-two of 107 (48%; 95% CI, 39%-58%) registered trials had a major discrepancy when the published manuscript was compared with the clinical trial registration. Thirty-one of the 46 (67%; 95% CI, 51%-80%) primary outcome discrepancies had changes in the outcome with characteristics of reporting bias. CONCLUSIONS: We detected a high rate of major discrepancies between the published results and the original registered protocols for clinical trial manuscripts in high-impact anesthesiology journals. Future action to reduce the negative impact of reporting bias in the anesthesiology field is warranted.

Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database.

BACKGROUND: The caudal block is the most commonly performed regional anesthesia technique in pediatric patients undergoing surgical procedures, but safety concerns raised by previous reports remain to be addressed. Our main objective in current investigation was to estimate the overall and specific incidence of complications associated with the performance of caudal block in children. METHODS: This was an observational study using the Pediatric Regional Anesthesia Network database. A complication after a caudal block was defined by the presence of at least 1 of the following: block failure, vascular puncture, intravascular test dose, dural puncture, seizure, cardiac arrest, sacral pain, or neurologic symptoms. In addition, if a complication was also coded, the presence of temporary or permanent sequelae was evaluated. Additional exploratory analyses were performed to identify patterns of local anesthetic dosage. RESULTS: Eighteen thousand six hundred-fifty children who received a caudal block were included in the study. The overall estimated incidence (95% confidence interval [CI]) of complications after caudal blocks was 1.9% (1.7%-2.1%). Patients who developed complications were younger, median (interquartile range) of 11 (5-24) months, compared to those who did not develop any complications, 14 (7-29) months, P = 0.001. The most common complications were block failure, blood aspiration, and intravascular injection. No cases of temporary or permanent sequelae were identified leading to an estimated incidence (95% CI) of 0.005% (- % to 0.03%). Four thousand four hundred-six of 17,867 (24.6%; 95% CI, 24%-25.2%) subjects received doses (>2 mg of bupivacaine equivalents/kg) that could be potentially unsafe. CONCLUSIONS: Safety concerns should not be a barrier to the use of caudal blocks in children assuming an appropriate selection of local anesthetic dosage.

Reliability and validity of assessing subspecialty level of faculty anesthesiologists' supervision of anesthesiology residents.

BACKGROUND: Supervision of anesthesiology residents is a major responsibility of faculty (academic) anesthesiologists. Supervision can be evaluated daily for individual anesthesiologists using a 9-question instrument. Faculty anesthesiologists with lesser individual scores contribute to lesser departmental (global) scores. Low (<3, "frequent") department-wide evaluations of supervision are associated with more mistakes with negative consequences to patients. With the long-term aim for residency programs to be evaluated partly based on the quality of their resident supervision, we assessed the 9-item instrument's reliability and validity when used to compare anesthesia programs' rotations nationwide. METHODS: One thousand five hundred residents in the American Society of Anesthesiologists' directory of anesthesia trainees were randomly selected to be participants. Residents were contacted via e-mail and requested to complete a Web-based survey. Nonrespondents were mailed a paper version of the survey. RESULTS: Internal consistency of the supervision scale was excellent, with Cronbach's α = 0.909 (95% CI, 0.896-0.922, n = 641 respondents). Discriminant validity was found based on absence of rank correlation of supervision score with characteristics of the respondents and programs (all P > 0.10): age, hours worked per week, female, year of anesthesia training, weeks in the current rotation, sequence of survey response, size of residency class, and number of survey respondents from the current rotation and program. Convergent validity was found based on significant positive correlation between supervision score and variables related to safety culture (all P < 0.0001): "Overall perceptions of patient safety," "Teamwork within units," "Nonpunitive response to errors," "Handoffs and transitions," "Feedback and communication about error," "Communication openness," and rotation's "overall grade on patient safety." Convergent validity was found also based on significant negative correlation with variables related to the individual resident's burnout (all P < 0.0001): "I feel burnout from my work," "I have become more callous toward people since I took this job," and numbers of "errors with potential negative consequences to patients [that you have] made and/or witnessed." Usefulness was shown by supervision being predicted by the same 1 variable for each of 3 regression tree criteria: "Teamwork within [the rotation]" (e.g., "When one area in this rotation gets busy, others help out"). CONCLUSIONS: Evaluation of the overall quality of supervision of residents by faculty anesthesiologists depends on the reliability and validity of the instrument. Our results show that the 9-item de Oliveira Filho et al. supervision scale can be applied for overall (department, rotation) assessment of anesthesia training programs.

The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial.

BACKGROUND: Tonsillectomy is a frequently performed surgical procedure in children; however, few multimodal analgesic strategies have been shown to improve postsurgical pain in this patient population. Systemic magnesium infusions have been shown to reliably improve postoperative pain in adults, but their effects in pediatric surgical patients remain to be determined. In the current investigation, our main objective was to evaluate the use of systemic magnesium to improve postoperative pain in pediatric patients undergoing tonsillectomy. We hypothesized that children who received systemic magnesium infusions would have less post-tonsillectomy pain than the children who received saline infusions. METHODS: The study was a prospective, randomized, double-blinded, clinical trial. Subjects were randomly assigned using a computer-generated table of random numbers to 1 of the 2 intervention groups: systemic magnesium infusion (initial loading dose 30 mg/kg given over 15 minutes followed by a continuous magnesium infusion 10 mg/kg/h) and the same volume of saline. The primary outcome was pain scores in the postanesthesia care unit (PACU) measured by FLACC (Face, Legs, Activity, Cry, Consolability) pain scores. Pain reduction was measured by the decrement in the area under the pain scale versus 90-minute postoperative time curve using the trapezoidal method. Secondary outcomes included opioid consumption in the PACU, emergence delirium scores (measured by the pediatric anesthesia emergence delirium scale), and parent satisfaction. RESULTS: Sixty subjects were randomly assigned and 60 completed the study. The area under pain scores (up to 90 minutes) was not different between the study groups, median (interquartile range [IQR]) of 30 (0-120) score × min and 45 (0-135) score × min for the magnesium and control groups, respectively (P = 0.74). Similarly, there was no clinically significant difference in the morphine consumption in the PACU between the magnesium group, median (IQR) of 2.0 (0-4.44) mg IV morphine, compared with the control, median (IQR) of 2.5 (0-4.99) mg IV morphine (P = 0.25). The serum level of magnesium was significantly lower in the control group than in the treatment group at the end of the surgery (P < 0.001). CONCLUSIONS: Despite a large number of studies demonstrating the efficacy of systemic magnesium for preventing postsurgical pain in adults, we could not find evidence for a significant clinical benefit of systemic magnesium infusion in children undergoing tonsillectomies. Our findings reiterate the importance of validating multimodal analgesic strategies in children that have been demonstrated to be effective in the adult population.