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OBJECTIVE: Thoracic surgery is associated with one of the highest rates of chronic postsurgical pain (CPSP) among all surgical subtypes. Chronic postsurgical pain carries significant medical, psychological, and economic consequences, and further interventions are needed to prevent its development. This study aimed to determine the prevalence, characteristics, and risk factors associated with CPSP after thoracic surgery. DESIGN: A prospective cohort study. SETTING: Single-center tertiary care hospital. PARTICIPANTS: This study included 285 adult patients who underwent thoracic surgery at Toronto General Hospital in Toronto, Canada, between 2012 and 2020. MEASUREMENTS AND MAIN RESULTS: Demographic, psychological, and clinical data were collected perioperatively, and follow-up evaluations were administered at 3, 6, and 12 months after surgery to assess CPSP. Chronic postsurgical pain was reported in 32.4%, 25.4%, and 18.2% of patients at 3, 6, and 12 months postoperatively, respectively. Average CPSP pain intensity was rated to be 3.37 (SD 1.82) at 3 months. Features of neuropathic pain were present in 48.7% of patients with CPSP at 3 months and 71% at 1 year. Multivariate logistic regression models indicated that independent predictors for CPSP at 3 months were scores on the Hospital Anxiety and Depression Scale (adjusted odds ratio [aOR] of 1.07, 95% CI of 1.02 to 1.14, p = 0.012) and acute postoperative pain (aOR of 2.75, 95% CI of 1.19 to 6.36, p = 0.018). INTERVENTIONS: None. CONCLUSIONS: Approximately 1 in 3 patients will continue to have pain at 3 months after surgery, with a large proportion reporting neuropathic features. Risk factors for pain at 3 months may include preoperative anxiety and depression and acute postoperative pain.
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Dor Crônica , Dor Pós-Operatória , Procedimentos Cirúrgicos Torácicos , Humanos , Masculino , Feminino , Estudos Prospectivos , Dor Pós-Operatória/epidemiologia , Dor Pós-Operatória/psicologia , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Fatores de Risco , Dor Crônica/epidemiologia , Dor Crônica/etiologia , Dor Crônica/psicologia , Pessoa de Meia-Idade , Prevalência , Procedimentos Cirúrgicos Torácicos/efeitos adversos , Idoso , Estudos de Coortes , Adulto , SeguimentosRESUMO
Purpose: Risk factors for the development of chronic postsurgical pain (CPSP) have been reported in primary studies and an increasing number of reviews. The objective of this umbrella review was to compile and understand the published presurgical risk factors associated with the development of CPSP for various surgery types. Methods: Six databases were searched from January 2000 to June 2023 to identify meta-analyses, scoping studies, and systematic reviews investigating presurgical CPSP predictors in adult patients. Articles were screened by title/abstract and subsequently by full text by two independent reviewers. The selected papers were appraised for their scientific quality and validity. Data were extracted and descriptively analyzed. Results: Of the 2344 retrieved articles, 36 reviews were selected for in-depth scrutiny. The number of primary studies in these reviews ranged from 4 to 317. The surgery types assessed were arthroplasty (n = 13), spine surgery (n = 8), breast surgery (n = 4), shoulder surgery (n = 2), thoracic surgery (n = 2), and carpal tunnel syndrome (n = 1). One review included a range of orthopedic surgeries; six reviews included a variety of surgeries. A total of 39 presurgical risk factors were identified, some of which shared the same defining tool. Risk factors were themed into six broad categories: psychological, pain-related, health-related, social/lifestyle-related, demographic, and genetic. The strength of evidence for risk factors was inconsistent across different reviews and, in some cases, conflicting. A consistently high level of evidence was found for preoperative pain, depression, anxiety, and pain catastrophizing. Conclusion: This umbrella review identified a large number of presurgical risk factors which have been suggested to be associated with the development of CPSP after various surgeries. The identification of presurgical risk factors is crucial for the development of screening tools to predict CPSP. Our findings will aid in designing screening tools to better identify patients at risk of developing CPSP and inform strategies for prevention and treatment.
Chronic postsurgical pain (CPSP) is pain experienced predominantly at the surgical site for longer than 3 months after a surgical procedure. Depending on surgery type, it can affect between 10 and 80% of people undergoing major surgeries, which may have negative effects such as a lower quality of life, disability, and persistent opioid use. Targeted identification and management of at risk patients in the presurgical phase may decrease the risk of CPSP. This umbrella review generated a list of potential risk factors for CPSP from evidence-based reviews of the current literature. Thirty-nine presurgical risk factors were identified in this review. Risk factors are divided into six broad categories: psychological, pain-related, health-related, demographic, genetic, and social/lifestyle-related. Although the strength of evidence for individual risk factors varied across reviews, risk factors in the psychological category consistently showed a strong impact on the development of CPSP. It is vital to understand which individuals are vulnerable and at risk for CPSP. The findings of this umbrella review will aid in designing screening tools to identify surgical candidates at risk. Some risk factors, such as genetics, cannot be altered. However, many identified risk factors are modifiable and may inform strategies for the prevention and treatment of CPSP using screening tools. Our findings may guide future research to consider an in-depth analysis of risk factor characterization to group modifiable presurgical risk factors. At risk patients will be offered psychological, physical, and pharmacological treatments accordingly to mitigate their risk of developing CPSP and ultimately improve patient outcomes in surgery.
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PURPOSE OF REVIEW: Medical cannabis (MC) has entered mainstream medicine by a unique route. Regulatory acceptance as a medical product in many jurisdictions has bypassed the traditional evidence-based pathway required for therapies. Easier access to MC, especially related to recreational legalization of cannabis, has led to widespread use by patients for symptom relief of a variety of medical conditions and often without medical oversight. Musculoskeletal pain remains the most common reason for MC use. This review examines real-world issues pertaining to MC and offers some guidance for clinical care of patients with rheumatic diseases being treated with MC. RECENT FINDINGS: Controlled clinical studies of cannabis products in patients with rheumatic diseases have been small and tested a range of compounds, routes of administration, and clinical populations, limiting our ability to generate conclusions on MC's effectiveness in this population. Observational cohort studies and surveys suggest that use of MC and related products in patients with rheumatic diseases improves pain and associated symptoms but is commonly accompanied by mild to moderate side effects. Conflicting evidence contributes to practitioner and patient uncertainty regarding the use of MC for rheumatic disease-related pain. Despite promising preclinical and observational evidence that MC and cannabis-derived compounds are useful in the management of rheumatic disease-related pain, there remains limited high-quality clinical evidence to substantiate these findings. There are a significant number of clinical trials on this topic currently planned or underway, however, suggesting the next decade may yield more clarity. Nevertheless, given that many people with rheumatic diseases are using cannabis products, healthcare professionals must remain apprised of the evidence pertaining to cannabinoids, communicate such evidence to patients in a meaningful way that is free from personal bias and stigma, and maintain strong collaborative clinical care pertaining to MC.
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INTRODUCTION: The Transitional Pain Service (TPS) is an innovative, personalized approach to postsurgical opioid consumption and pain management. The objectives of this study were to identify trajectories of opioid consumption and pain intensity within 12 months after initiating treatment through the TPS, identify biopsychosocial factors associated with trajectory membership, and examine the relationship between trajectory membership and other outcomes of interest over the same 12-month period. METHODS: Consecutive patients referred to the TPS were included in the present study (n=466). After providing informed consent, they completed self-report questionnaires at the initial visit at the TPS (either pre surgery or post surgery) and at every TPS visit until 12 months. Growth mixture modeling was used to derive trajectories and identify associated factors. RESULTS: Results showed three distinct opioid consumption trajectories for both presurgical opioid consumers and opioid-naïve patients. These trajectories all decreased over time and among those who were consuming opioids before surgery that returned to presurgical levels. Being man, having a substance use disorder, or reporting higher levels of pain interference were associated with higher daily opioid consumption for presurgical opioid consumers. For presurgical opioid-naïve individuals, higher opioid consumption trajectories were associated with higher levels of psychological distress. Five pain intensity trajectories were identified, and there were no significant association between opioid consumption and pain intensity trajectories. CONCLUSIONS: Results suggest that opioid consumption and pain intensity trajectories mostly decrease after surgery in a high-risk population enrolled in a TPS. Results also show heterogeneity in postsurgical recovery and highlight the importance of using personalized interventions to optimize individual trajectories.
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Substance use disorders, including alcohol use disorder, are a public health concern that affect more than 150 million people globally. The opioid antagonist naltrexone is being increasingly prescribed to treat opioid use disorder, alcohol use disorder, and chronic pain. Perioperative management of patients on naltrexone is inconsistent and remains a controversial topic, with mismanagement posing a significant risk to the long-term health of these patients. This scoping review was conducted to identify human studies in which the perioperative management of naltrexone was described. This review includes a systematic literature search involving Medline, Medline In-Process, Embase, PsycINFO, and Web of Science. Seventeen articles that describe perioperative naltrexone management strategies were included, including thirteen guidelines, one case report, and three randomized trials. Despite its use in patients with alcohol use disorder and chronic pain, no clinical studies, case reports, or guidelines addressed naltrexone use in these clinical populations. All of the guideline documents recommended the preoperative cessation of naltrexone, irrespective of dose, indication, or route of administration. None of these guideline documents were designed on the basis of a systematic literature search or a Delphi protocol. As described by the primary studies, perioperative pain relief varied depending on naltrexone dose and route of administration, time since last naltrexone administration, and underlying substance use disorder. None of the studies commented on the maintenance of recovery for the patient's substance use disorder in the context of perioperative naltrexone management. The current understanding of the risks and benefits of continuing or stopping naltrexone perioperatively is limited by a lack of high-quality evidence. In patients with risk factors for return to use of opioids or alcohol, the discontinuation of naltrexone should have a strong rationale. Future studies and guidelines should seek to address both acute pain management and maintaining recovery when discussing perioperative naltrexone management strategies.
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Naltrexona , Antagonistas de Entorpecentes , Assistência Perioperatória , Naltrexona/uso terapêutico , Naltrexona/administração & dosagem , Humanos , Antagonistas de Entorpecentes/uso terapêutico , Antagonistas de Entorpecentes/administração & dosagem , Assistência Perioperatória/métodos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológicoRESUMO
Synthetic cannabinoids are compounds made in the laboratory to structurally and functionally mimic phytocannabinoids from the Cannabis sativa L. plant, including delta-9-tetrahydrocannabinol (THC). Synthetic cannabinoids (SCs) can signal via the classical endogenous cannabinoid system (ECS) and the greater endocannabidiome network, highlighting their signalling complexity and far-reaching effects. Dronabinol and nabilone, which mimic THC signalling, have been approved by the Food and Drug Administration (FDA) for treating nausea associated with cancer chemotherapy and/or acquired immunodeficiency syndrome (AIDS). However, there is ongoing interest in these two drugs as potential analgesics for a variety of other clinical conditions, including neuropathic pain, spasticity-related pain, and nociplastic pain syndromes including fibromyalgia, osteoarthritis, and postoperative pain, among others. In this review, we highlight the signalling mechanisms of FDA-approved synthetic cannabinoids, discuss key clinical trials that investigate their analgesic potential, and illustrate challenges faced when bringing synthetic cannabinoids to the clinic.
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Canabinoides , Dor , Humanos , Canabinoides/farmacologia , Canabinoides/uso terapêutico , Canabinoides/efeitos adversos , Canabinoides/síntese química , Dor/tratamento farmacológico , Animais , Analgésicos/farmacologia , Analgésicos/uso terapêutico , Dronabinol/farmacologia , Dronabinol/uso terapêutico , Medicamentos Sintéticos/farmacologia , Medicamentos Sintéticos/uso terapêuticoRESUMO
BACKGROUND: The belief that cannabis has analgesic and anti-inflammatory properties continues to attract patients with chronic musculoskeletal (MSK) pain towards its use. However, the role that cannabis will play in the management of chronic MSK pain remains to be determined. This study examined 1) the rate, patterns of use, and self-reported efficacy of cannabis use among patients with chronic MSK pain and 2) the interest and potential barriers to cannabis use among patients with chronic MSK pain not currently using cannabis. METHODS: Self-reported cannabis use and perceived efficacy were prospectively collected from chronic MSK pain patients presenting to the Orthopaedic Clinic at the University Health Network, Toronto, Canada. The primary dependent variable was current or past use of cannabis to manage chronic MSK pain; bivariate and multivariable logistic regression were used to identify patient characteristics independently associated with this outcome. Secondary outcomes were summarized descriptively, including self-perceived efficacy among cannabis users, and interest as well as barriers to cannabis use among cannabis non-users. RESULTS: The sample included 629 patients presenting with chronic MSK pain (mean age: 56±15.7 years; 56% female). Overall, 144 (23%) reported past or present cannabis use to manage their MSK pain, with 63.7% perceiving cannabis as very or somewhat effective and 26.6% considering it as slightly effective. The strongest predictor of cannabis use in this study population was a history of recreational cannabis use (OR 12.7, p<0.001). Among cannabis non-users (N=489), 65% expressed interest in using cannabis to manage their chronic MSK pain, but common barriers to use included lack of knowledge regarding access, use and evidence, and stigma. CONCLUSIONS: One in five patients presenting to an orthopaedic surgeon with chronic MSK pain are using or have used cannabis with the specific intent to manage their pain, and most report it to be effective. Among non-users, two-thirds reported an interest in using cannabis to manage their MSK pain, but common barriers to use existed. Future double-blind placebo-controlled trials are required to understand if this reported efficacy is accurate, and what role, if any, cannabis may play in the management of chronic MSK pain.
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Background: Chronic pain is a complex disease that requires interprofessional care for effective management. Despite the need for multidisciplinary care, disease and health care inequities can prevent individuals from attaining adequate treatment. Factors such as mental health, cost, and distance to a health care center can contribute to health care accessibility inequality. The aim of this study is to examine declined referrals at the Toronto Academic Pain Medicine Institute (TAPMI) to determine the reason for declining care and number of declined referrals. Methods: A retrospective chart review of all declined referrals at TAPMI in 2018 and 2022 was conducted. Referral documentation and the intake decision were extracted from the electronic medical charts by the research team and verified by the clinical intake team. Chi-square tests were conducted to determine whether the proportion of declined referrals changed between the years reviewed. Results: The number of declined referrals due to mental health complexities increased significantly from 51 (11%) in 2018 to 180 (18%) in 2022 (χ2 = 10.9, P = 0.0009). A significant rise in the number of declines due to mental health service requests was also observed (χ2 = 24.53, P < 0.00001). Other common reasons for declined referrals in 2018 and 2022 included duplicate service, no primary care provider, and health care service changes. Conclusion: Mental health complexities continue to be a significant barrier to health care service acquisition for individuals living with chronic pain. The increase in patient complexity from 2018 to 2022 highlights the need for integrated health care resources.
Contexte: La douleur chronique est une maladie complexe qui nécessite des soins interprofessionnels pour une prise en charge efficace. Malgré la nécessité de soins multidisciplinaires, les maladies et les iniquités en matière de soins de santé peuvent empêcher les individus d'obtenir un traitement adéquat. Des facteurs tels que la santé mentale, le coût et la distance d'un centre de soins de santé peuvent contribuer aux inégalités en matière d'accessibilité des soins de santé. Le but de cette étude est d'examiner les demandes de consultation refusées à l'Institut universitaire de médecine de la douleur de Toronto (TAPMI) afin de déterminer la raison du refus des soins et le nombre de demandes de consultation refusées.Méthodes: Un examen rétrospectif de toutes les demandes de consultation refusées au TAPMI en 2018 et 2022 a été effectué. La documentation relative à la demande de consultation et la décision d'admission ont été extraites du dossier médical électronique par l'équipe de recherche et vérifiées par l'équipe d'admission clinique. Des tests de chi-carré ont été effectués pour déterminer si la proportion de demandes de consultation refusées avait changé entre les années examinées.Résultats: Le nombre de demandes de consultation refusées en raison des complexités de la santé mentale a considérablement augmenté, passant de 51 (11 %) en 2018 à 180 (18%) en 2022 (χ2 = 10,9, P = 0,0009). Une augmentation significative du nombre de refus attribuables aux demandes de services de santé mentale a également été observée (χ2 = 24,53, P < 0,00001). Parmi les autres raisons courantes pour lesquelles les demandes de consultation ont été refusées en 2018 et 2022, on compte la duplication du service, l'absence de prestataire de soins primaires et les changements dans les services de soins de santé.Conclusion: Les complexités de la santé mentale continuent d'être un obstacle important à l'acquisition de services de soins de santé pour les personnes vivant avec une douleur chronique. L'augmentation de la complexité des patients de 2018 à 2022 souligne la nécessité de ressources de soins de santé intégrées.
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BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. TRIAL REGISTRATION: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
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Anestésicos Locais , Neoplasias da Mama , Lidocaína , Mastectomia , Estudos Multicêntricos como Assunto , Dor Pós-Operatória , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Lidocaína/administração & dosagem , Lidocaína/efeitos adversos , Neoplasias da Mama/cirurgia , Feminino , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Mastectomia/efeitos adversos , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Infusões Intravenosas , Resultado do Tratamento , Medição da Dor , Qualidade de Vida , Dor Crônica/prevenção & controle , Dor Crônica/etiologia , Mastectomia Segmentar/efeitos adversos , Fatores de Tempo , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/efeitos adversos , Análise Custo-BenefícioRESUMO
Introduction: Cannabis use has been associated with reduced physical activity and increased sedentary behavior in adolescents. In adults, however, there is no conclusive evidence of such an association, and existing studies have primarily relied on self-reported activity measures. As cannabis use increases globally, a deeper understanding of its relationship with activity levels may inform clinical counseling and guidelines. This study investigated the association between recent cannabis use and accelerometer-measured activity. Methods: Data were obtained from the National Health and Nutrition Examination Survey (NHANES) from 2011 to 2014. We included adults in the United States who responded to a cannabis questionnaire and had at least 4 days of activity data from an ActiGraph GT3X+ accelerometer, which comprised participants from 18 to 59 years. The primary exposure was any self-reported cannabis use in the past 30 days. The primary outcome was daily sedentary time and secondary outcomes were daily light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA). Analyses were performed with multivariable quasi-Poisson regression models. Results: Of 4666 included adults, 658 (14.1%) reported recent cannabis use. After covariate adjustment, recent cannabis use was not associated with daily sedentary time (adjusted incidence rate ratio [aIRR] 0.99, 95% confidence interval [CI]: 0.98-1.01) or daily MVPA time (aIRR 1.01, 95% CI: 0.98-1.04). Daily LPA time was 4% greater with recent cannabis use (aIRR 1.04, 95% CI: 1.01-1.06). Conclusion: Recent cannabis use in young to midlife adults was not associated with accelerometer-measured sedentary or MVPA time, but it was associated with a marginal increase in LPA time of unclear clinical significance. Our findings provide evidence against existing concerns that cannabis use independently promotes sedentary behavior and decreases physical activity. Future prospective studies are needed to determine if these findings generalize to specific populations using cannabis including chronic pain patients.
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Background: Despite the established efficacy of multidisciplinary chronic pain care, barriers such as inflated referral wait times and uncoordinated care further hinder patient health care access. Aims: Here we describe the evolution of a single-entry model (SEM) for coordinating access to chronic pain care across seven hospitals in Toronto and explore the impact on patient care 6 years after implementation. Methods: In 2017, an innovative SEM was implemented for chronic pain referrals in Toronto and surrounding areas. Referrals are received centrally, triaged by a clinical team, and assigned an appointment according to the level of urgency and the most appropriate care setting/provider. To evaluate the impact of the SEM, a retrospective analysis was undertaken to determine referral patterns, patient characteristics, and referral wait times over the past 6 years. Results: Implementation of an SEM streamlined the number of steps in the referral process and led to a standardized referral form with common inclusion and exclusion criteria across sites. Over the 6-year period, referrals increased by 93% and the number of unique providers increased by 91%. Chronic pain service wait times were reduced from 299 (±158) days to 176 (±103) days. However, certain pain diagnoses such as chronic pelvic pain and fibromyalgia far exceed the average. Conclusions: The results indicate that the SEM helped reduce wait times for pain conditions and standardized the referral pathway. Continued data capture efforts can help identify gaps in care to enable further health care refinement and improvement.
Contexte: Malgré l'efficacité établie des soins multidisciplinaires dans le traitement de la douleur chronique, des obstacles tels que des délais d'attente prolongés et l'absence de coordination des soins entravent davantage l'accès des patients aux services de santé.Objectifs: Nous décrivons ici l'évolution d'un modèle à entrée unique visant à coordonner l'accès aux soins pour la douleur chronique dans sept hôpitaux de Toronto. Nous examinons également l'effet de ce modèle sur les soins aux patients six ans après sa mise en Åuvre.Méthodes: En 2017, un modèle à entrée unique novateur a été mis en place pour orienter les patients souffrant de douleur chronique à Toronto et dans les régions avoisinantes. Les patients sont reçus de manière centralisée, triés par une équipe clinique et un rendez-vous leur est attribué en fonction du degré d'urgence et de l'établissement de soins ou du prestataire le plus approprié.Pour évaluer l'impact du modèle à entrée unique, une analyse rétrospective a été entreprise afin de déterminer les schémas de consultation, les caractéristiques des patients et les temps d'attente pour les demandes de consultation au cours des six dernières années.Résultats: La mise en Åuvre d'un modèle à entrée unique a permis de rationaliser le nombre d'étapes du processus de demande de consultation et a conduit à l'élaboration d'un formulaire de demande de consultation normalisé comprenant des critères d'inclusion et d'exclusion communs à tous les sites. Au cours de la période de six ans, le nombre de demandes de consultation a augmenté et le nombre de prestataires uniques a augmenté de 91 %.Les temps d'attente pour les services de traitement de la douleur chronique ont diminué de 299 (±158) jours à 176 (±103) jours. Cependant, certains diagnostics de douleur, comme la douleur pelvienne chronique et la fibromyalgie, dépassent de loin la moyenne.Conclusions: Les résultats indiquent que le modèle à entrée unique a contribué à réduire les temps d'attente pour les affections douloureuses et à normaliser le parcours de consultation. La poursuite des efforts de collecte des données peut aider à recenser les lacunes dans les soins, permettant ainsi une amélioration continue des soins de santé.
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BACKGROUND: Chronic pain affects approximately 8 million Canadians (~20%), impacting their physical and mental health while burdening the health care system with costs of upwards of US $60 billion a year. Indeed, patients are often trialed on numerous medications over several years without reductions to their symptoms. Therefore, there is an urgent need to identify new therapies for chronic pain to improve patients' quality of life, increase the availability of treatment options, and reduce the burden on the health care system. OBJECTIVE: The primary objective of this study is to examine the feasibility of a parallel 3-arm pilot randomized controlled trial whereby patients are randomized to either intravenous ketamine alone, cognitive behavioral therapy (CBT) and mindfulness meditation (MM) training (CBT/MM), or the combination of intravenous ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination intravenous ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or intravenous ketamine alone (assessed at week 20 of the study). METHODS: This is a single-center, 16-week, 3-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael's Hospital, Toronto, Ontario, which receives 1000 referrals per year. Patients will be enrolled in the study for a total of 20 weeks. Participants who are allocated CBT/MM therapy will receive remote weekly psychotherapy from week 1 to week 16, inclusive of health coaching administered through the NexJ Health Inc (NexJ Health) platform. Patients who are allocated ketamine-infusion therapy will receive monthly ketamine infusion treatments on weeks 2, 7, and 12. Patients who are allocated ketamine+CBT/MM will receive weekly psychotherapy from weeks 1 to 16, inclusive, as well as ketamine infusion treatments on weeks 2, 7, and 12. We will be assessing recruitment rates, consent rates, withdrawal rates, adherence, missing data, and adverse events as pilot outcome measures. Secondary clinical outcomes include changes relative to baseline in pain intensity and pain interference. RESULTS: As of November 1, 2023, the recruitment process has not been initiated. Given the recruitment, consent, and intervention target of 30 participants for this feasibility study, with each patient undergoing monitoring and treatments for a course of 20 weeks, we expect to complete the study by December 2025. CONCLUSIONS: This study assesses the feasibility of conducting a 3-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a population with chronic neuropathic pain. The results of this pilot randomized controlled trial will inform the development of a larger-scale randomized controlled trial. Future studies will be aimed at including a sufficiently powered sample that will inform decisions about optimal treatment calibration and treatment effect duration. TRIAL REGISTRATION: ClinicalTrials.gov NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54406.
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Introduction: Clinical hypnosis has been proposed for post-surgical pain management for its potential vagal-mediated anti-inflammatory properties. Evidence is needed to understand its effectiveness for post-surgical recovery. Iin this secondary outcome study, it was hypothesized that surgical oncology patients randomized to receive perioperative clinical hypnosis (CH) would demonstrate greater heart-rate variability (HRV) during rest and relaxation at a 1-month post-surgery assessment compared to a treatment-as-usual group (TAU). Methods: After REB approval, trial registration and informed consent, 92 participants were randomized to receive CH (n = 45) or TAU (n = 47). CH participants received a CH session before surgery and during post-surgical in-hospital stay HRV was assessed during rest (5â min) and relaxation (10â min) before and 1-month after surgery. Pain intensity was obtained using a 0-10 numeric rating scale pre and post 1-week and 1-month post surgery. Results: One month after surgery, HRV was significantly higher in CH group (n = 29) during rest and relaxation (both p < 0.05, d = 0.73) than TAU group (n = 28). By contrast, rest and relaxation HRV decreased from pre- to 1-month post-surgery for the TAU (both p < 0.001, d > 0.48) but not the CH group. Pain intensity increased from pre-surgery to 1-week post-surgery (p < 0.001, d = 0.50), and decreased from 1-week to 1-month post-surgery (p = 0.005, d = 0.21) for all participants. Discussion: The results suggest that hypnosis prevents the deleterious effects of surgery on HRV by preserving pre-operative vagal activity. These findings underscore the potential of clinical hypnosis in mitigating the adverse effects of surgery on autonomic function and may have significant implications for enhancing post-surgical recovery and pain management strategies. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT03730350).
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INTRODUCTION: Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored. The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs. MATERIALS AND METHODS: TOPCOP3 is a multi-centre, factorial pilot clinical trial coupled with an embedded process evaluation. The study includes four treatment arms: geriatric assessment and management (GA + M); remote symptom monitoring (RSM); geriatric assessment and management plus remote symptom monitoring; and usual care and will be followed for six months. The aim is to recruit 168 patients between two cancer centres in Toronto, Canada. Eligible participants will be randomized equally via REDCap. Participants in all arms will complete a comprehensive baseline assessment upon enrollment following the Geriatric Core dataset, as well as follow-up assessments at 1.5, 3, 4.5, and 6 months. The co-primary outcomes will be grade 3-5 toxicity and QOL. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. QOL will be measured by patient self-reporting using the EuroQol 5 dimensions of health questionnaire. Secondary outcomes include fatigue, insomnia, and depression. Finally, four process evaluation outcomes will also be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. DISCUSSION: Data will be collected to observe the effects of GA + M and RSM on QOL and toxicities experienced by older adults receiving ARATs for metastatic prostate cancer. Data will also be collected to help the design and conduct of a definitive multicentre phase III randomized controlled trial. This study will extend supportive care interventions for older adults with cancer into new areas and inform the design of larger trials. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (registration number: NCT05582772).
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Avaliação Geriátrica , Neoplasias da Próstata , Qualidade de Vida , Humanos , Masculino , Projetos Piloto , Idoso , Neoplasias da Próstata/patologia , Neoplasias da Próstata/terapia , Avaliação Geriátrica/métodos , Antagonistas de Receptores de Andrógenos/uso terapêutico , Idoso de 80 Anos ou mais , Metástase NeoplásicaRESUMO
INTRODUCTION: Older adults with metastatic prostate cancer (mPC) experience high symptom burden associated with treatment. Frailty may exacerbate treatment toxicity. The aim of this study was to explore short-term treatment toxicity in patients with metastatic prostate cancer. MATERIALS AND METHODS: Older adults with metastatic prostate cancer starting chemotherapy, androgen-receptor-axis targeted therapies, or radium-223 participated in a prospective, multicentre, observational study. Participants self-reported symptoms daily using the Edmonton Symptom Assessment System for one treatment cycle via internet or telephone. The most common moderate-to-severe symptoms (score≥4), their duration, and the proportion of participants who experienced improvements in symptom severity (score<4) after reporting moderate-to-severe symptoms at baseline were determined using descriptive statistics. Once-weekly symptom questionnaires were administered and analyzed using linear mixed effect models. Symptom incidence, duration, and frailty associations were assessed using t-tests and chi-square tests. RESULTS: Ninety participants completed the study (mean age=77 years [standard deviation=6.1], 42% frail [Vulnerable Elders Survey≥3]). The most common moderate-to-severe symptoms across cohorts were fatigue (46.8%), insomnia (42.9%), poor wellbeing (41.2%), pain (37.5%), and decreased appetite (37.1%). Poor wellbeing had a higher incidence in frail participants (62.5% in frail vs. 31.4% in non-frail, p=0.039). Symptom duration varied across cohorts and between frail and non-frail participants. Among participants who reported moderate-to-severe symptoms at baseline, no more than 15% improved in any symptom. There were statistically significant improvements in weekly symptoms for fatigue, decreased appetite, and insomnia in the chemotherapy cohort only. DISCUSSION: Limitations include a short follow-up duration, lack of a control group, and few radium-223 participants. Regular symptom monitoring can help clinicians understand temporal patterns and durations of symptoms and inform supportive care approaches.
Assuntos
Fragilidade , Neoplasias da Próstata , Rádio (Elemento) , Distúrbios do Início e da Manutenção do Sono , Masculino , Idoso , Humanos , Fragilidade/epidemiologia , Idoso Fragilizado , Estudos Prospectivos , Incidência , Neoplasias da Próstata/tratamento farmacológico , Fadiga/epidemiologia , Fadiga/etiologiaRESUMO
Clinical hypnosis is an effective strategy for managing acute pain in the surgical setting. However, the opioid sparing effects of clinical hypnosis are not as well understood. This pre-registered (NCT03730350) randomized, controlled trial (RCT) examined the impact of clinical hypnosis, pre- and post-surgery, on opioid consumption during hospitalization as well as on measures of pain intensity, pain interference, depressed mood, anxiety, sleep, and pain catastrophizing. Participants (M = 57.6 years; SD = 10.9) awaiting oncologic surgery were randomized to treatment-as-usual (n = 47) or hypnosis (n = 45). Intent-to-treat analyses were conducted using linear mixed effects modeling. A significant Group × Time interaction, F(6, 323.34) = 3.32, p = 0.003, indicated an opioid sparing effect of clinical hypnosis during the acute postoperative period. Hypnosis also protected against increases in pain catastrophizing at one-week after surgery, F (1, 75.26) = 4.04, p = 0.048. A perioperative clinical hypnosis intervention had a sparing effect on opioid consumption in-hospital after major oncologic surgery. These findings extend the efficacy of clinical hypnosis as an adjunct tool for perioperative pain management.
Assuntos
Dor Crônica , Reumatologia , Humanos , Dor Crônica/diagnóstico , Registros Eletrônicos de SaúdeRESUMO
BACKGROUND: Understanding the association of acute pain intensity and opioid consumption after cardiac surgery with chronic postsurgical pain (CPSP) can facilitate implementation of personalized prevention measures to improve outcomes. The objectives were to (1) examine acute pain intensity and daily mg morphine equivalent dose (MME/day) trajectories after cardiac surgery, (2) identify factors associated with pain intensity and opioid consumption trajectories, and (3) assess whether pain intensity and opioid consumption trajectories are risk factors for CPSP. METHODS: Prospective observational cohort study design conducted between August 2012 and June 2020 with 1-year follow-up. A total of 1115 adults undergoing cardiac surgery were recruited from the preoperative clinic. Of the 959 participants included in the analyses, 573 completed the 1-year follow-up. Main outcomes were pain intensity scores and MME/day consumption over the first 6 postoperative days (PODs) analyzed using latent growth mixture modeling (GMM). Secondary outcome was 12-month CPSP status. RESULTS: Participants were mostly male (76%), with a mean age of 61 ± 13 years. Three distinct linear acute postoperative pain intensity trajectories were identified: "initially moderate pain intensity remaining moderate" (n = 62), "initially mild pain intensity remaining mild" (n = 221), and "initially moderate pain intensity decreasing to mild" (n = 251). Age, sex, emotional distress in response to bodily sensations, and sensitivity to pain traumatization were significantly associated with pain intensity trajectories. Three distinct opioid consumption trajectories were identified on the log MME/day: "initially high level of MME/day gradually decreasing" (n = 89), "initially low level of MME/day remaining low" (n = 108), and "initially moderate level of MME/day decreasing to low" (n = 329). Age and emotional distress in response to bodily sensations were associated with trajectory membership. Individuals in the "initially mild pain intensity remaining mild" trajectory were less likely than those in the "initially moderate pain intensity remaining moderate" trajectory to report CPSP (odds ratio [95% confidence interval, CI], 0.23 [0.06-0.88]). No significant associations were observed between opioid consumption trajectory membership and CPSP status (odds ratio [95% CI], 0.84 [0.28-2.54] and 0.95 [0.22-4.13]). CONCLUSIONS: Those with moderate pain intensity right after surgery are more likely to develop CPSP suggesting that those patients should be flagged early on in their postoperative recovery to attempt to alter their trajectory and prevent CPSP. Emotional distress in response to bodily sensations is the only consistent modifiable factor associated with both pain and opioid trajectories.