Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

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).

Self-Reported Pain Treatment Practices Among U.S. and Canadian Adults: Findings From a Population Survey.

Background and Objectives: Pain treatments and their efficacy have been studied extensively. Yet surprisingly little is known about the types of treatments, and combinations of treatments, that community-dwelling adults use to manage pain, as well as how treatment types are associated with individual characteristics and national-level context. To fill this gap, we evaluated self-reported pain treatment types among community-dwelling adults in the United States and Canada. We also assessed how treatment types correlate with individuals' pain levels, sociodemographic characteristics, and country of residence, and identified unique clusters of adults in terms of treatment combinations. Research Design and Methods: We used the 2020 "Recovery and Resilience" United States-Canada general online survey with 2 041 U.S. and 2 072 Canadian community-dwelling adults. Respondents selected up to 10 pain treatment options including medication, physical therapy, exercise, etc., and an open-ended item was available for self-report of any additional treatments. Data were analyzed using descriptive, regression-based, and latent class analyses. Results: Over-the-counter (OTC) medication was reported most frequently (by 55% of respondents, 95% CI 53%-56%), followed by "just living with pain" (41%, 95% CI 40%-43%) and exercise (40%, 95% CI 38%-41%). The modal response (29%) to the open-ended item was cannabis use. Pain was the most salient correlate, predicting a greater frequency of all pain treatments. Country differences were generally small; a notable exception was alcohol use, which was reported twice as often among U.S. versus Canadian adults. Individuals were grouped into 5 distinct clusters: 2 groups relied predominantly on medication (prescription or OTC), another favored exercise and other self-care approaches, one included adults "just living with" pain, and the cluster with the highest pain levels employed all modalities heavily. Discussion and Implications: Our findings provide new insights into recent pain treatment strategies among North American adults and identify population subgroups with potentially unmet need for more adaptive and effective pain management.

Chronic opioid use after joint replacement surgery in seniors is associated with increased healthcare utilization and costs: a historical cohort study.

PURPOSE: Postoperative opioid use may be associated with increased healthcare utilization and costs. We sought to examine the relationship between duration of postoperative opioid prescriptions and healthcare costs and resource utilization in senior patients following hip and knee replacement. METHODS: We conducted a historical cohort study evaluating postoperative opioid use and healthcare costs in patients over the age of 65 yr undergoing primary total hip or knee arthroplasty over a ten-year period from 1 April 2006 to 31 March 2016. The last follow-up date was 31 March 2017. We identified preoperative and postoperative opioid prescriptions, patient characteristics, and healthcare costs using deidentified Ontario administrative databases (Institute of Clinical Evaluative Sciences). Duration of postoperative opioid use was divided into four categories: short-term (1-90 days), prolonged (91-180 days), chronic (181-365 days), and undocumented. RESULTS: The study included 49,638 hip and 85,558 knee replacement patients. Although the initial hospitalization accounted for the greatest cost in all patients, over the following year patients in the short-term opioid use group incurred the lowest average costs, and those in the chronic group incurred the highest (hip, CAD 17,528 vs CAD 26,736; knee, CAD 16,043 vs CAD 23,007), driven by increased healthcare resource utilization. CONCLUSION: Chronic opioid use after arthroplasty was associated with higher resource utilization and healthcare costs during the year following surgery. These results can be used to develop predictors of longer opioid use and higher costs. Further research is planned to determine whether recently implemented opioid reduction strategies can reduce healthcare resource utilization.

RéSUMé: OBJECTIF: L'utilisation postopératoire d'opioïdes peut être associée à une augmentation de l'utilisation et des coûts des soins de santé. Nous avons cherché à examiner la relation entre la durée des ordonnances d'opioïdes postopératoires, les coûts des soins de santé et l'utilisation des ressources chez les patients âgés après une arthroplastie de la hanche et du genou. MéTHODE: Nous avons réalisé une étude de cohorte historique évaluant la consommation postopératoire d'opioïdes et les coûts des soins de santé chez les patients de plus de 65 ans subissant une arthroplastie totale primaire de la hanche ou du genou sur une période de dix ans allant du 1er avril 2006 au 31 mars 2016. La dernière date de suivi était le 31 mars 2017. Nous avons identifié les ordonnances pré- et postopératoires d'opioïdes, les caractéristiques des patients et les coûts des soins de santé à l'aide de bases de données administratives de l'Ontario désidentifiées (ICES). La durée de la consommation d'opioïdes postopératoires était divisée en quatre catégories : à court terme (1 à 90 jours), prolongée (91 à 180 jours), chronique (181 à 365 jours) et non documentée. RéSULTATS: L'étude a porté sur 49 638 patients ayant subi une arthroplastie de la hanche et 85 558 patients une arthroplastie du genou. Bien que l'hospitalisation initiale ait représenté le coût le plus élevé chez tous les patients, au cours de l'année suivante, les patients du groupe de consommation d'opioïdes à court terme ont encouru les coûts moyens les plus bas et ceux du groupe chronique les coûts les plus élevés (hanche, 17 528 CAD vs 26 736 CAD; genou, 16 043 CAD vs 23 007 CAD) en raison de l'utilisation accrue des ressources de soins de santé. CONCLUSION: La consommation chronique d'opioïdes après une arthroplastie a été associée à une augmentation de l'utilisation des ressources et des coûts des soins de santé au cours de l'année suivant la chirurgie. Ces résultats peuvent être utilisés pour développer des modèles de prédiction d'une consommation prolongée d'opioïdes et de coûts plus élevés. D'autres recherches sont prévues pour déterminer si les stratégies de réduction de la consommation d'opioïdes récemment mises en œuvre pourront réduire l'utilisation des ressources en soins de santé.

Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

ABSTRACT: Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.

Accessing care in multidisciplinary pain treatment facilities continues to be a challenge in Canada.

BACKGROUND: Multidisciplinary pain treatment facilities (MPTFs) are considered the optimal settings for the management of chronic pain (CP). This study aimed (1) to determine the distribution of MPTFs across Canada, (2) to document time to access and types of services, and (3) to compare the results to those obtained in 2005-2006. METHODS: This cross-sectional study used the same MPTF definition as in 2005-2006-that is, a clinic staffed with professionals from a minimum of three different disciplines (including at least one medical specialty) and whose services were integrated within the facility. A comprehensive search strategy was used to identify existing MPTFs across Canada. Administrative leads at each MPTF were invited to complete an online questionnaire regarding their facilities. RESULTS: Questionnaires were completed by 104 MPTFs (response rate 79.4%). Few changes were observed in the distribution of MPTFs across Canada compared with 12 years ago. Most (91.3%) are concentrated in large urban cities. Prince Edward Island and the Territories still lack MPTFs. The number of pediatric-only MPTFs has nearly doubled but remains small (n=9). The median wait time for a first appointment in publicly funded MPTFs is about the same as 12 years ago (5.5 vs 6 months). Small but positive changes were also observed. CONCLUSION: Accessibility to public MPTFs continues to be limited in Canada, resulting in lengthy wait times for a first appointment. Community-based MPTFs and virtual care initiatives to distribute pain services into regional and remote communities are needed to provide patients with CP with optimal care.

Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study.

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

Delivery of electroconvulsive therapy in Canada: a first national survey report on usage, treatment practice, and facilities.

OBJECTIVES: The aims of this study were to document electroconvulsive therapy use in Canada with respect to treatment facilities and caseloads based on a survey of practice (Canadian Electroconvulsive Therapy Survey/Enquete Canadienne Sur Les Electrochocs-CANECTS/ECANEC) and to consider these findings in the context of guideline recommendations. METHOD: All 1273 registered hospitals in Canada were contacted, and 175 sites were identified as providing electroconvulsive therapy; these sites were invited to complete a comprehensive questionnaire. The survey period was calendar year 2006 or fiscal year 2006/2007. National usage rates were estimated from the responses. RESULTS: Sixty-one percent of the sites completed the questionnaire; a further 10% provided caseload data. Seventy were identified as general; 31, as university teaching; and 21, as provincial psychiatric/other single specialty (psychiatric) hospitals. Caseload volumes ranged from a mean of fewer than 2 to greater than 30 treatments per week. Estimated national usage during the 1-year survey period was 7340 to 8083 patients (2.32-2.56 per 10,000 population) and 66,791 to 67,424 treatments (2.11-2.13 per 1000 population). The diagnostic indications, admission status, and protocols for course end points are described. CONCLUSIONS: The usage rates are in keeping with earlier Canadian data and with those from other jurisdictions. The difficulty obtaining caseload data from individual hospitals is indicative of the need for standardized data collection to support both clinical research and quality assurance. The wide variation in protocols for number of treatments per course indicates a need for better informed clinical guidelines. The broad range of caseload volumes suggests the need to review the economies of scale in the field.

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.

The development of valid and informative treatment risk-benefit profiles requires consistent and thorough information about adverse event (AE) assessment and participants' AEs during randomized controlled trials (RCTs). Despite a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement recommending the specific AE information that investigators should report, there is little evidence that analgesic RCTs adequately adhere to these recommendations. This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinically important AE information. Using this checklist, we coded AE assessment methods and reporting in all 80 double-blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain, Journal of Pain, and PAIN® from 2006 to 2011. Across all trials, reports of AEs were frequently incomplete, inconsistent across trials, and, in some cases, missing. For example, >40% of trials failed to report any information on serious adverse events. Trials of participants with acute or chronic pain conditions and industry-sponsored trials typically provided more and better-quality AE data than trials involving pain-free volunteers or trials that were not industry sponsored. The results of this review suggest that improved AE reporting is needed in analgesic RCTs. We developed an ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications.

Canadian survey of perianesthetic care for patients receiving electroconvulsive therapy.

OBJECTIVES: We report on the anesthesia subsection of a comprehensive nationwide survey (Canadian Electroconvulsive Therapy Survey/Enquête canadienne sur les electrochocs) on the practice of electroconvulsive therapy (ECT) in Canada. METHODS: This comprehensive survey was sent to the 175 Canadian institutions identified as providers of ECT in 2007. Among other topics, 9 anesthesia-related questions were administered regarding anesthesiology consultation; high-risk patients; credentials of the anesthesia provider; monitoring, airway, and resuscitation equipment; anesthetic induction, muscle relaxant, vasoactive, and other perianesthetic drugs and practices; and postanesthetic discharge. RESULTS: Sixty-one percent (107/175) of the institutions returned completed survey questionnaires. More than 70% of the sites reported pre-ECT anesthesiology consultation for all (61%) or most (11%) patients. In more than 90%, a Canadian Royal College-certified anesthesiologist, or equivalent, provided anesthetic care. Routine use of oximetry, electrocardiography, and blood pressure monitoring were reported by all but 2 sites; use of bite block was reported by all but 4 sites; and preoxygenation was reported by all but 7 sites. Dantrolene and capnography were not reported as readily available by 35% and 40%, respectively, with comparatively less frequent availability at non-operating room and lower-volume sites. CONCLUSIONS: These results suggest safe practices of anesthesia for ECT in Canada. Further attention needs to be paid to ready availability of dantrolene and capnography, particularly at non-operating room ECT sites. Improvements in anesthetic care of patients undergoing ECT may be realized through continued knowledge translation efforts and by expanding access to currently unavailable anesthetic induction agents and, in some settings, limited clinical anesthesiology resources.

Access to electroconvulsive therapy services in Canada.

OBJECTIVES: We sought to determine factors governing access to electroconvulsive therapy (ECT) in Canada. METHODS: We contacted all 1273 registered health care institutions in Canada and invited the 175 centers identified as providing ECT to complete a comprehensive questionnaire. To determine geographic access to ECT, we used a geographic information system, population density data, and road network data. Responses to 5 questions from the questionnaire were used to identify local barriers to access. RESULTS: Approximately 84% of the population in the 10 Canadian provinces live within a 1-hour drive of an ECT center, but 5% live more than 5 hours' drive away. There was significant province-to-province variation, with all of the citizens of Prince Edward Island living within 2 hours of an ECT center but 12.5% of those in Newfoundland and Labrador living more than 5 hours' distance away. There are no ECT services at all in the 3 territories, which contain 3% of the Canadian population. Nongeographic barriers to access included inadequate human resources, particularly, a lack of anesthesiologists, in 59% of the centers; logistical impedances (52%); space limitations (45%); strictures on the hiring of adequate staff (29%); imposed limits to number of treatments or to operating or postanesthetic room time (28%); and a lack of funds to purchase up-to-date ECT or related anesthesiology equipment (14%). CONCLUSIONS: Electroconvulsive therapy is geographically accessible for most Canadians. Even when geography is not a factor, however, there are significant barriers to access resulting from inadequate availability of qualified professional staff, treatment areas, and funding.