Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial.

BACKGROUND: The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported. OBJECTIVE: To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia. DESIGN: Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505). SETTING: 46 U.S. and Canadian hospitals. PARTICIPANTS: Patients aged 50 years or older undergoing hip fracture surgery. INTERVENTION: Spinal or general anesthesia. MEASUREMENTS: Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care. RESULTS: A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups. LIMITATION: Missing outcome data and multiple outcomes assessed. CONCLUSION: Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults.

BACKGROUND: The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. METHODS: We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days. RESULTS: A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P = 0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30). CONCLUSIONS: Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia. (Funded by the Patient-Centered Outcomes Research Institute; REGAIN ClinicalTrials.gov number, NCT02507505.).

Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults.

Engaging patients-defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them-as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Preoperative Sedative-hypnotic Medication Use and Adverse Postoperative Outcomes.

OBJECTIVE: To determine the association between preoperative benzodiazepine and nonbenzodiazepine receptor agonist ("Z-drugs") use and adverse outcomes after surgery. BACKGROUND: Prescriptions for benzodiazepines and Z-drugs have increased over the past decade. Despite this, the association of preoperative benzodiazepines and Z-drug receipt with adverse outcomes after surgery is unknown. METHODS: Using the Optum Clinformatics Datamart, we performed a retrospective cohort study of adults 18 years or older who underwent any of 10 common surgical procedures between 2010 and 2015. The principal exposure was one or more filled prescriptions for a benzodiazepine or Z-drug in the 90 days before surgery. The primary outcome was any emergency department visit or hospital admission for either (1) a drug related adverse medical event or overdose or (2) a traumatic injury in the 30 days after surgery. RESULTS: Of 785,346 patients meeting inclusion criteria, 94,887 (12.1%) filled a preoperative prescription for a benzodiazepine or Z-drug. From multivariable logistic regression, benzodiazepine or Z-drug use was associated with an increased odds of an adverse postoperative event [odds ratio 1.13; 95% confidence interval: 1.08-1.18). In a separate regression, coprescription of benzodiazepines or Z-drugs with opioids was associated with a 1.45 odds of an adverse postoperative event (95% confidence interval: 1.37-1.53). CONCLUSIONS: Preoperative benzodiazepines and Z-drug use is common and associated with increased odds of adverse outcomes after surgery, particularly when coprescribed with opioids. Counseling on appropriate benzodiazepine and Z-drug use in advance of elective surgery may potentially increase the safety of surgical care.

Nerve Block Use after Hip Fracture Versus Elective Hip or Knee Arthroplasty: Retrospective Analysis.

OBJECTIVES: Although peripheral nerve blocks are associated with improved pain control and end outcomes among older adults with hip fracture, their current utilization among US hip fracture patients is not well understood. We characterized contemporary use of peripheral nerve blocks after hip fracture over time and identified predictors of nerve block receipt. DESIGN: Retrospective cohort study of claims data from one large national private US insurer. SETTING: US acute care hospitals. PARTICIPANTS: A total of 94 985 adults aged 50 years and older hospitalized for a femoral neck, intertrochanteric, or subtrochanteric fracture; 409 263 adults aged 50 years and older hospitalized for elective hip or knee arthroplasty between 2004 and 2016. MEASUREMENTS: Receipt of a peripheral nerve block for pain control, based on Current Procedural Terminology codes in physician service claims. RESULTS: Overall, 2874 hip fracture patients (3.0%; 95% confidence interval [CI] = 2.9-3.1) received a nerve block for pain control, and the percentage receiving a block increased from .4% in 2004-2006 (95% CI = .3%-.6%) to 4.6% in 2013-2016 (95% CI = 4.4%-4.8%; P < .001). The adjusted odds of receiving a nerve block was lower for patients with vs without dementia (odds ratio [OR] = .88; 95% CI = .80-.98; P = .02) and among patients aged 75 to 84 vs 64 years or younger (OR = .86; 95% CI = .74-1.00; P = .02). The odds of nerve block receipt did not vary according to race, ethnicity, fracture location, or most other common comorbidities. Compared with patients with hip fracture, the adjusted odds of nerve block receipt were 2 times higher among patients undergoing elective hip replacement and more than 30 times higher among patients undergoing elective knee replacement. CONCLUSION: Although use of peripheral nerve blocks for pain control after hip fracture has increased over time, fewer than 5 of every 100 patients hospitalized with hip fracture currently receive a peripheral nerve block, suggesting possible underuse. J Am Geriatr Soc 68:835-840, 2020.

Opioid Prescribing After Surgery in the United States, Canada, and Sweden.

Importance: Small studies and anecdotal evidence suggest marked differences in the use of opioids after surgery internationally; however, this has not been evaluated systematically across populations receiving similar procedures in different countries. Objective: To determine whether there are differences in the frequency, amount, and type of opioids dispensed after surgery among the United States, Canada, and Sweden. Design, Setting, and Participants: This cohort study included patients without previous opioid prescriptions aged 16 to 64 years who underwent 4 low-risk surgical procedures (ie, laparoscopic cholecystectomy, laparoscopic appendectomy, arthroscopic knee meniscectomy, and breast excision) between January 2013 and December 2015 in the United States, between July 2013 and March 2016 in Canada, and between January 2013 and December 2014 in Sweden. Data analysis was conducted in all 3 countries from July 2018 to October 2018. Main Outcomes and Measures: The main outcome was postoperative opioid prescriptions filled within 7 days after discharge; the percentage of patients who filled a prescription, the total morphine milligram equivalent (MME) dose, and type of opioid dispensed were compared. Results: The study sample consisted of 129 379 patients in the United States, 84 653 in Canada, and 9802 in Sweden. Overall, 52 427 patients (40.5%) in the United States were men, with a mean (SD) age of 45.1 (12.7) years; in Canada, 25 074 patients (29.6%) were men, with a mean (SD) age of 43.5 (13.0) years; and in Sweden, 3314 (33.8%) were men, with a mean (SD) age of 42.5 (13.0). The proportion of patients in Sweden who filled an opioid prescription within the first 7 days after discharge for any procedure was lower than patients treated in the United States and Canada (Sweden, 1086 [11.1%]; United States, 98 594 [76.2%]; Canada, 66 544 [78.6%]; P < .001). For patients who filled a prescription, the mean (SD) MME dispensed within 7 days of discharge was highest in United States (247 [145] MME vs 169 [93] MME in Canada and 197 [191] MME in Sweden). Codeine and tramadol were more commonly dispensed in Canada (codeine, 26 136 patients [39.3%]; tramadol, 12 285 patients [18.5%]) and Sweden (codeine, 170 patients [15.7%]; tramadol, 315 patients [29.0%]) than in the United States (codeine, 3210 patients [3.3%]; tramadol, 3425 patients [3.5%]). Conclusions and Relevance: The findings indicate that the United States and Canada have a 7-fold higher rate of opioid prescriptions filled in the immediate postoperative period compared with Sweden. Of the 3 countries examined, the mean dose of opioids for most surgical procedures was highest in the United States.

Time to institutional review board approval with local versus central review in a multicenter pragmatic trial.

BACKGROUND/AIMS: Central institutional review board (IRB) review will be required for National Institutes of Health-funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial. METHODS: The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval). RESULTS: The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35-134) versus 58 days for sites approved via local review (interquartile range: 41-105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by the central IRB was 27 days (interquartile range: 14-32) versus 66 days (interquartile range: 29-138) for sites approved via local review (p = 0.026). The median total time from protocol receipt to IRB approval was 100 days (interquartile range: 71-148) for centrally approved sites versus 132 days (interquartile range: 87-209) for locally approved sites (p = 0.191). CONCLUSION: While central IRB review was associated with a shorter time from IRB submission to IRB approval compared to local IRB review, the total time from protocol receipt to IRB approval varied markedly across sites.

Active surveillance for asymptomatic colonization with multidrug-resistant gram negative bacilli among injured service members--a three year evaluation.

In response to the high rates of colonization and infection by multidrug-resistant gram-negative bacilli (MDR GNB), many military treatment facilities (MTFs) have implemented additional infection control practices, such as active surveillance cultures for asymptomatic colonization. Results of surveillance cultures (June 2009 - May 2012) collected from patients at Landstuhl Regional Medical Center (Landstuhl RMC), Germany, and three U.S. MTFs were analyzed to evaluate trends in MDR GNB colonization over time and across facilities. At Landstuhl RMC, 6.6 percent of patients were colonized on admission with MDR GNB compared to 12.4 percent of patients admitted to the participating U.S. MTFs. Escherichia coli was the predominant organism, representing 82.4 percent of MDR isolates at Landstuhl RMC and 67.1 to 83.3 percent at U.S. MTFs. Other common MDR GNB included Acinetobacter calcoaceticus-baumannii complex and Klebsiella pneumoniae. Although Pseudomonas aeruginosa was often isolated from the surveillance cultures, it was never multidrug-resistant. Annual rates of MDR GNB colonization were not significantly different over the three-year period. Ongoing research includes assessment of predictive factors for MDR GNB colonization and the relationship between colonization and infection.

Invasive mold infections following combat-related injuries.

BACKGROUND: Major advances in combat casualty care have led to increased survival of patients with complex extremity trauma. Invasive fungal wound infections (IFIs) are an uncommon, but increasingly recognized, complication following trauma that require greater understanding of risk factors and clinical findings to reduce morbidity. METHODS: The patient population includes US military personnel injured during combat from June 2009 through December 2010. Case definition required wound necrosis on successive debridements with IFI evidence by histopathology and/or microbiology (Candida spp excluded). Case finding and data collected through the Trauma Infectious Disease Outcomes Study utilized trauma registry, hospital records or operative reports, and pathologist review of histopathology specimens. RESULTS: A total of 37 cases were identified: proven (angioinvasion, n=20), probable (nonvascular tissue invasion, n=4), and possible (positive fungal culture without histopathological evidence, n=13). In the last quarter surveyed, rates reached 3.5% of trauma admissions. Common findings include blast injury (100%) during foot patrol (92%) occurring in southern Afghanistan (94%) with lower extremity amputation (80%) and large volume blood transfusion (97.2%). Mold isolates were recovered in 83% of cases (order Mucorales, n=16; Aspergillus spp, n=16; Fusarium spp, n=9), commonly with multiple mold species among infected wounds (28%). Clinical outcomes included 3 related deaths (8.1%), frequent debridements (median, 11 cases), and amputation revisions (58%). CONCLUSIONS: IFIs are an emerging trauma-related infection leading to significant morbidity. Early identification, using common characteristics of patient injury profile and tissue-based diagnosis, should be accompanied by aggressive surgical and antifungal therapy (liposomal amphotericin B and a broad-spectrum triazole pending mycology results) among patients with suspicious wounds.

Antimicrobial prescribing practices following publication of guidelines for the prevention of infections associated with combat-related injuries.

BACKGROUND: Timely and limited antibiotic prophylaxis (postinjury antimicrobial therapy) targeting specific traumatic injuries is a well-recognized measure to lessen posttraumatic infection. Modern military combat injuries raise significant challenges because of complex multiple injuries and limited data derived directly from well-controlled trials to base recommendations. Expert consensus review of available evidence led to published guidance for selection and duration of antimicrobial therapy for combat-related trauma infection prevention. This analysis evaluates antibiotic-prescribing practices by military physicians in the operational theater relative to the published guidance. METHODS: Trauma history and infectious disease-specific inpatient care information is captured through the Joint Theater Trauma Registry along with a supplemental infectious disease module. Injury patterns are classified based on documented International Classification of Diseases-9th Revision codes with a composite assessment of each patient's injury pattern. Antimicrobial use categorized as prophylaxis is prescribed within the first 48 hours postinjury. Adherence to published guidance is reported along with patient characteristics and injury severity to assess for potential explanations of nonadherence. RESULTS: During June to November 2009, 75% of the 610 eligible trauma patients received antimicrobial prophylaxis. Adherence to the recommended antibiotic agent on the day of injury was in the range of 46% to 50% for the most common extremity injury patterns and <10% in penetrating abdominal injuries. Antibiotics were given in 39% of patients sustaining injuries that are recommendations to not receive antimicrobial prophylaxis. CONCLUSIONS: This first evaluation of combat trauma-related antibiotic prophylaxis shows adherence levels comparable or superior to reported rates in civilian settings despite the austere, frequently mass casualty environment. Areas for interval surveillance and education-based strategies for improved adherence to practice guidance are identified.