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INTRODUCTION: Lowering opioid prescription doses and quantity decreases the risk of chronic opioid usage. A tool was inserted into the brief operative note for the surgeon to assess the severity of pain associated with the procedure. We studied surgeon adherence to current opioid-prescribing recommendations. METHODS: Retrospective cohort study with 5486 patients were included in the study population. Each patient's prescription was scored yes or no for adherence on total morphine milligram equivalents (MMEs) and days prescribed with the selection in the brief operative note. The entire study population was tested for an increase from the null-hypothesis "benchmark" value of 75% using a one-sided exact binomial test of a single proportion with P < 0.05. This procedure was repeated for subgroups, with P < 0.01. RESULTS: Adherence to guidelines was higher than the 75% benchmark for "total MMEs prescribed" (79.5%; P < 0.001), but lower for "number of days prescribed" (63.5%; P > 0.999). Surgeries with severe predicted pain showed the highest adherence toward total MMEs prescribed at 87.1%, followed by moderate (80.5%) and mild (74.5%). Severe cases also showed the highest adherence in number of days prescribed (92.4%). Adherence to total MMEs prescribed was highest among attending physicians (88.1%) and lowest among residents/fellows (76.6%). CONCLUSIONS: Adherence to current guidelines was 79.5% for MMEs prescribed but only 63.5% for days prescribed. Compliance with guidelines was better for severe procedures than mild or moderate. Differences were seen across surgical departments. While an improvement from previous reports, further improvement is needed to reduce the number of days of opioids prescribed and increase compliance with recommended guidelines.
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Analgésicos Opioides , Padrões de Prática Médica , Humanos , Analgésicos Opioides/uso terapêutico , Estudos Retrospectivos , Dor , Hospitais , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controleRESUMO
OBJECTIVES: Total knee arthroplasty (TKA) is an effective surgery for end-stage knee osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, but percutaneous peripheral nerve stimulation (PNS) is a promising nonopioid treatment option for chronic, persistent postoperative pain. The objective of the present study was to evaluate the effect of a 60-day percutaneous PNS treatment in a multicenter, randomized, double-blind, placebo-controlled trial for treating persistent postoperative pain after TKA. MATERIALS AND METHODS: Patients with postoperative pain after knee replacement were screened for this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects in both groups underwent ultrasound-guided placement of percutaneous fine-wire coiled leads targeting the femoral and sciatic nerves on the leg with postoperative pain. Leads were indwelling for eight weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ≥50% reduction in average pain relative to baseline during weeks five to eight. Functional outcomes (6-minute walk test; 6MWT and Western Ontario and McMaster Universities Osteoarthritis Index) and quality of life (Patient Global Impression of Change) also were evaluated at end of treatment (EOT). RESULTS: A greater proportion of subjects in the PNS groups (60%; 12/20) than in the placebo (sham) group (24%; 5/21) responded with ≥50% pain relief relative to baseline (p = 0.028) during the primary endpoint (weeks 5-8). Subjects in the PNS group also walked a significantly greater distance at EOT than did those in the placebo (sham) group (6MWT; +47% vs -9% change from baseline; p = 0.048, n = 18 vs n = 20 completed the test, respectively). Prospective follow-up to 12 months is ongoing. CONCLUSIONS: This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.
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Artroplastia do Joelho , Dor Pós-Operatória , Estimulação Elétrica Nervosa Transcutânea , Humanos , Masculino , Feminino , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Método Duplo-Cego , Idoso , Dor Pós-Operatória/terapia , Dor Pós-Operatória/etiologia , Pessoa de Meia-Idade , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do Tratamento , Medição da Dor/métodos , Recuperação de Função Fisiológica/fisiologiaRESUMO
PURPOSE OF REVIEW: The current review aims to empower anesthesiologists, specifically pain medicine specialists, to become leaders in ensuring equitable care. RECENT FINDINGS: Disparities in both acute and chronic pain medicine lead to increased morbidity for patients of color. Gaps in care include misdiagnosis or under diagnosis of chronic pain disease states, undertreatment of sickle cell disease and other conditions that are common in minorities, under prescription of opioids, and lack of access to novel opioid sparing treatments. While the causes of these disparities are multifactorial, care team implicit bias and lack of representation are two of the major factors. Solutions are challenging, but the authors suggest an inside out solution. We believe that this practice will have far-reaching downstream effects, including improving diversity in our field and quality of care for our patients. SUMMARY: The current article reviews disparities in both acute and chronic pain treatment for underrepresented racial and ethnic minorities in the United States. The authors examine whether implicit bias and lack of representation are a contributing factor for these disparities. Lastly, we will discuss potential solutions.
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Dor Crônica , Analgésicos Opioides , Dor Crônica/diagnóstico , Dor Crônica/terapia , Etnicidade , Humanos , Manejo da Dor , Estados UnidosRESUMO
OBJECTIVE: Diversity and equity in medicine remain pivotal to care delivery. Data analysis on sex and racial diversity of pain medicine fellowship trainees and faculty in the United States are scant. We sought to characterize demographic and retention patterns among pain medicine fellows and faculty, who represent the emerging chronic pain management workforce. DESIGN: cross-sectional retrospective analysis. METHOD: We conducted an analysis of data from the American Association of Medical Colleges (AAMC) and the United States Accreditation Council on Graduate Medical Education (ACGME)-approved residency and fellowship training-programs for each year from 2009 through 2019, inclusively. We compared changes in sex, racial/ethnicity composition and retention rates of fellows and faculty in the United States by practice setting. RESULTS: From 2009 to 2019, there was a 14% increase in the number of ACGME pain fellowship programs. From 2009 to 2019, the ratio of men to women pain fellows ranged from 5:1 to 3.7:1. Compared with their self-identified White peers, Asian (OR 0.44; 95% CI: 0.34-0.58), Black (OR 0.46; 95% CI: 0.30-0.72), and Native American/Alaskan Native (OR 0.26; 95% CI: 0.08-0.80) identifying individuals had significantly lower odds of being a pain fellow, P < 0.05. There was no significant difference in female (OR = 0.4, 95% CI: 0.148-1.09) and Black (OR 0.36; 95% CI: 0.11-1.12) program-directors. Pain-fellow in-state retention was 53%. CONCLUSIONS: The demographics of pain medicine training programs reflect a persistent male vs. female gap with underrepresentation of racial minorities. Further research is needed to elucidate reasons underlying these disparities.
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Educação de Pós-Graduação em Medicina , Bolsas de Estudo , Estudos Transversais , Docentes , Feminino , Humanos , Masculino , Dor , Estudos Retrospectivos , Estados UnidosRESUMO
BACKGROUND: Dorsal root ganglion stimulation (DRGS) is an effective treatment for complex regional pain syndrome (CRPS) and post-surgical neuropathic pain. However, some patients have surgical and anatomical conditions that are contraindications to traditional DRGS technique. A novel transgrade approach to DRGS placement has been described and demonstrated effective for post spine surgery patients. We present three patients, each with a different reason in which DRGS would not be accessible via the traditional anterograde approach, who all had successful DRGS transgrade placement. MATERIALS AND METHODS: The case series includes three patients with either CRPS or post-surgical neuropathic pain who had an anatomical or post-surgical condition that historically would have rendered DRGS contraindicated. Two patients had previously failed dorsal column stimulation. All three patients had successful placement with the transgrade approach-entry into the contralateral epidural space at the level of the targeted foramen from a cephalad angle. Each patient gave their verbal and written consent to be included in the case series. RESULTS: Following treatment with a transgrade approach, all three patients had significant pain relief and improvement in function without complication. CONCLUSION: Barriers to anterograde foraminal access including previous implantation, previous instrumentation, and epidural adhesions may prevent DRGS placement in certain indicated patients. This can be especially challenging in patients who have failed other neuromodulation options like dorsal column stimulation. Our case series demonstrated that the transgrade technique can be successfully used in these cases to increase access to DRGS.
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Síndromes da Dor Regional Complexa , Estimulação da Medula Espinal , Gânglios Espinais , Humanos , Manejo da Dor , Terapia de SalvaçãoRESUMO
INTRODUCTION: Significant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes would be helpful. With increased focus on the use of patient-reported outcomes to improve care, we aim to evaluate the National Institute of Health Patient Reported Outcome Measurement Information System measures for an association with successful SCS trials in patients with persistent pain. METHODS: Our prospective, observational study enrolled 60 patients with persistent pain who underwent an SCS trial. Patients completed demographic and Patient Reported Outcome Measurement Information System computer adaptive test (PROMIS CAT) assessments to measure self-reported pain interference, depression, anxiety, physical functioning, and sleep disturbance at the time they presented for placement of their trial device. RESULTS: Of the 58 patients who underwent successful electrode placement, 11 had an unsuccessful trial. There were no differences in patient demographics between patients with a successful and an unsuccessful trial. Patients who had a successful SCS trial reported lower pre-trial levels of anxiety, depression, and sleep disturbance and decreased post-trial levels of depression, sleep disturbance, and pain interference. CONCLUSIONS: We found that patients with high levels of depression, anxiety, and sleep disturbance using the PROMIS CAT were predictive of unsuccessful trials. In addition, we found that patients with successful SCS trials reported lower levels of these domains on PROMIS CAT administered at the end of the trial.
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INTRODUCTION: Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction. METHODS: Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups. RESULTS: A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria ("Day 0 successes") and those who did not ("needed longer to evaluate the therapy"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders. CONCLUSIONS: The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes. TRIAL REGISTRATION: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).
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The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.
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AIMS: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). METHODS: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding. RESULTS: At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection. CONCLUSIONS: Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN. TRIAL REGISTRATION: ClincalTrials.gov Identifier, NCT03228420.
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Diabetes Mellitus , Neuropatias Diabéticas , Estimulação da Medula Espinal , Humanos , Estimulação da Medula Espinal/métodos , Neuropatias Diabéticas/terapia , Qualidade de Vida , Estudos Prospectivos , Dor , Resultado do TratamentoRESUMO
Objective: Spinal cord stimulation is a proven, evidence-based therapy for persistent spinal pain syndrome. While some patients with this disease are managed by chronic pain physicians, many are managed in primary care offices. Despite mounting evidence, dissemination of this research outside of neuromodulation related fields and implementation of this treatment in common practice has not yet occurred. We hypothesize that family medicine residents in rural training programs will have little knowledge of neuromodulation despite it being an evidence-based and common treatment of post-laminectomy syndrome. Materials and Methods: Online surveys were sent to family medicine residents in six rural family medicine training programs at the University of Arkansas for Medical Sciences Regional Programs to characterize knowledge of neuromodulation as a treatment for post-laminectomy syndrome. Results: Forty-one percent of responding rural, Arkansas family medicine residents reported treating post-laminectomy syndrome during their training, yet only 10% have referred a patient for neuromodulation consultation. Residents rated their knowledge of neuromodulation/spinal cord stimulation at 19 on a scale of 0 (no knowledge) to 100 (extensive knowledge). Conclusion: Despite proof that neuromodulation is an evidence-based treatment for post-laminectomy/failed back syndrome, rural family medicine residents have limited knowledge about the therapy and many do not consider a referral for neuromodulation. Further research to ascertain effective implementation strategies to increase the uptake of neuromodulation for patients with post-laminectomy syndrome is desperately needed.
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Social media has revolutionized internet communication and become ubiquitous in modern life. Though it originated as a medium for friendship, social media has evolved into an ideal venue for professional networking, scientific exchange, and brand building. As such, it is a powerful tool with which interventional pain physicians should become familiar. However, given the permanence and visibility of online posts, it is prudent for interventional pain physicians to utilize social media in a manner that is consistent with the ethical and professionalism standards to which they are held by their patients, employers, peers, and state medical boards. While there are extensive publications of professional codes of conduct by medical societies, there is a paucity of literature regarding social media best practices guidelines. Further, to date there have been no social media best practices recommendations specific to interventional pain medicine physicians. While not exhaustive, the aim of this document is to provide recommendations to pain physicians on how to maintain an effective professional and ethical online presence. Specifically, we provide guidance on online persona and professional image, patient-physician interactions online, patient privacy, industry relations, patient education, and brand building.
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Knee pain is second only to the back as the most commonly reported area of pain in the human body. With an overall prevalence of 46.2%, its impact on disability, lost productivity, and cost on healthcare cannot be overlooked. Due to the pervasiveness of knee pain in the general population, there are no shortages of treatment options available for addressing the symptoms. Ranging from physical therapy and pharmacologic agents to interventional pain procedures to surgical options, practitioners have a wide array of options to choose from - unfortunately, there is no consensus on which treatments are "better" and when they should be offered in comparison to others. While it is generally accepted that less invasive treatments should be offered before more invasive ones, there is a lack of agreement on the order in which the less invasive are to be presented. In an effort to standardize the treatment of this extremely prevalent pathology, the authors present an all-encompassing set of guidelines on the treatment of knee pain based on an extensive literature search and data grading for each of the available alternative that will allow practitioners the ability to compare and contrast each option.
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Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were "satisfied" or "very satisfied" with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420.
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OBJECTIVE: The aim of this study was to evaluate whether a video-based, patient-focused opioid education tool delivered in the perioperative period would decrease acute and chronic post-operative opioid prescription dispensations and increase self-rated knowledge about opioids. METHODS: We enrolled 110 patients with no reported opioid use in the previous 30 days, undergoing ambulatory surgery for breast, orthopedic, gynecologic, or other outpatient procedures for which opioids would be prescribed. Patients were randomized to receive either post-operative opioid education by the surgical team (control arm) or pre-operative education via a novel 5-minute video plus post-operative education by the surgical team (intervention arm). All patients received follow-up phone calls on post-operative day (POD) 7 to assess self-rated knowledge of opioids on a scale of 1 to 10, 10 being most informed, and self-reported opioid use (primary outcome). Arkansas Prescription Drug Monitoring Program (AR PDMP) data were obtained to assess opioid dispensations at POD 90-150 days. RESULTS: Seventy-seven percent of participants completed POD7 survey. Participants in the intervention arm rated their knowledge of opioids after surgery significantly higher than those in the control arm (p=0.013). Data from the AR PDMP reveal trends (non-significant) that show increased use of opioids in the control group when compared to the video intervention group at POD 30 (88.7% vs 76%) and POD 90-150 (22.6% vs 10%). CONCLUSION: Video-based, patient-focused opioid education can be effectively implemented in a large university hospital during the perioperative period and is effective for increasing a patient's perception of opioid-related knowledge. A fully powered, randomized control trial is needed to further explore observed trends and determine if this novel tool can decrease chronic post-operative opioid dispensations.
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OBJECTIVE: Arkansas Improving Multidisciplinary Pain Care and Treatment (AR-IMPACT) is an interprofessional team that delivers televideo case conferences to help providers optimize treatment of pain using nonopioid, evidence-based therapies. This article assesses AR-IMPACT using the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework. DESIGN: A cross-sectional study. SETTING: Large, academic medical center. PARTICIPANTS: Healthcare providers. INTERVENTIONS: Televideo case conferences. MAIN OUTCOME MEASURES: Reach was evaluated by the number of participants, professions represented, and counties/states in which providers resided. Efficacy was assessed via a participant evaluation survey. Adoption was evaluated by calculating the number of repeat participants and soliciting information on barriers to adoption of conference recommendations in clinical practice using the participant evaluation survey. Implementation was evaluated by calculating the time and cost burden of the program. RESULTS: Reach was widespread; continuing education (CE) credits have been claimed by 395 providers in 54 of the 75 counties in Arkansas and 18 states outside Arkansas. For efficacy, the majority of providers noted increases in their knowledge due to AR-IMPACT (89.6 percent). Like reach, adoption was also extensive; approximately 42 percent of AR-IMPACT participants attended more than one conference, and close to 56 percent of participants noted no barriers to adopting the changes discussed in the conferences. With implementation, the time requirements for developing a case conference ranged from 2 to 4 hours, and the cost per CE credit was $137, which is on par with other programs. CONCLUSIONS: AR-IMPACT was successful, particularly in reach and efficacy. Entities that implement programs similar to AR-IMPACT will likely experience extensive uptake by providers.
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Analgésicos Opioides , Dor , Arkansas , Estudos Transversais , Humanos , Avaliação de Programas e Projetos de SaúdeRESUMO
Moderate to severe pain occurs in many cancer patients during their clinical course and may stem from the primary pathology, metastasis, or as treatment side effects. Uncontrolled pain using conservative medical therapy can often lead to patient distress, loss of productivity, shorter life expectancy, longer hospital stays, and increase in healthcare utilization. Various publications shed light on strategies for conservative medical management for cancer pain and a few international publications have reviewed limited interventional data. Our multi-institutional working group was assembled to review and highlight the body of evidence that exists for opioid utilization for cancer pain, adjunct medication such as ketamine and methadone and interventional therapies. We discuss neurolysis via injections, neuromodulation including targeted drug delivery and spinal cord stimulation, vertebral tumor ablation and augmentation, radiotherapy and surgical techniques. In the United States, there is a significant variance in the interventional treatment of cancer pain based on fellowship training. As a first of its kind, this best practices and interventional guideline will offer evidenced-based recommendations for reducing pain and suffering associated with malignancy.
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Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). Design, Setting, and Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated. Interventions: Implanted medical device delivering 10-kHz SCS. Main Outcomes and Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months. Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001). Conclusions and Relevance: Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN. Trial Registration: ClincalTrials.gov Identifier: NCT03228420.
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Neuropatias Diabéticas/diagnóstico , Neuropatias Diabéticas/terapia , Manejo da Dor/métodos , Medição da Dor/métodos , Estimulação da Medula Espinal/métodos , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND AND OBJECTIVES: We sought to describe a case of an epidural hematoma after a cervical interlaminar epidural steroid injection (ILESI) performed using contralateral oblique view. We also discuss factors that could have placed this patient at increased risk, including concurrent use of omega-3 fatty acids and non-steroidal anti-inflammatory medications. CASE REPORT: A 74-year-old woman returned to the pain clinic, within 15 min of discharge, after an apparent uncomplicated cervical ILESI using the contralateral oblique technique with severe periscapular pain and muscle spasms. Cervical MRI showed a large epidural hematoma which was subsequently emergently evacuated. On postoperative examination, the patient had no neurologic deficits and full resolution of her painful symptoms. CONCLUSIONS: To our knowledge, this is the first reported case of cervical epidural hematoma in which the contralateral oblique technique was used. Also, this is the second case in which the combination of non-steroidal anti-inflammatory medications and omega-3 fatty acids has been considered as a contributor to increased hematoma risk. This case underscores the risk of epidural hematoma using a novel fluoroscopic technique and the need for potential discontinuation of supplements like omega-3 fatty acids.
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Vértebras Cervicais/diagnóstico por imagem , Dexametasona/administração & dosagem , Ácidos Graxos Ômega-3/administração & dosagem , Glucocorticoides/administração & dosagem , Hematoma Epidural Espinal/diagnóstico por imagem , Hematoma Epidural Espinal/tratamento farmacológico , Idoso , Espaço Epidural/diagnóstico por imagem , Feminino , Humanos , Injeções EpiduraisRESUMO
Postmastectomy pain syndrome poses a significant treatment challenge. We present the case of a 42-year-old woman who presented to our pain clinic with a 16-month history of postmastectomy pain. We performed a combined superficial and deep serratus plane block using bupivacaine, dexamethasone, and clonidine. At 1-month follow-up, the patient had 100% pain relief. At 2-month follow-up, her pain was 5/10. The block was repeated with the same drugs at 3 months with similar pain relief. This case illustrates the utility of a combined superficial and deep serratus plane block in postmastectomy pain syndrome with a possible benefit from added dexamethasone and clonidine.
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Analgésicos , Anestésicos , Bupivacaína , Dor Crônica/tratamento farmacológico , Clonidina , Dexametasona , Bloqueio Nervoso , Dor Pós-Operatória/tratamento farmacológico , Adulto , Quimioterapia Combinada , Feminino , Humanos , Mastectomia , Manejo da DorRESUMO
We present a case of a 68-year-old woman with 6 months of chronic unilateral posterior thigh pain after a total knee arthroplasty. The patient's pain was refractory to various treatments. After appropriate diagnostic tests, a genicular nerve block and subsequent radiofrequency ablation were performed. These procedures provided substantial pain relief of her thigh pain at 3 months follow-up.