Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty.

BACKGROUND: Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. METHODS: This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo usual care. The primary outcomes of this pilot trial are to assess the feasibility of participant recruitment, retention, and adherence to the interventions, and key secondary outcomes are persisting pain and opioid use. DISCUSSION: The results of this trial will determine the feasibility of conducting a definitive trial for the implementation of a multicomponent pain pathway to improve pain control and reduce harms using a coordinated approach, while keeping an emphasis on patient centred care and shared decision making. TRIAL REGISTRATION: Prospectively registered in Clinicaltrials.gov (NCT04968132).

A Systematic Review of the Recruitment and Outcome Reporting by Sex and Race/Ethnicity in Stent Device Development Trials for Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Women and racial/ethnic minority groups have been shown to experience poor outcomes after endovascular aortic aneurysm repair (EVAR). One potential reason is the rare inclusion of these populations in initial phases of device development. The objective of this systematic review is to understand enrollment and outcome reporting by sex and race/ethnicity in industry-funded EVAR device development trials. METHODS: MEDLINE, PubMed, and Embase were searched from inception to January 2022 without language restrictions using the following terminology: "stent", "graft", "endograft", "device", and "abdominal aortic aneurysm" (AAA). CLINICALTRIALS: gov was also searched from inception to January 2022 for "AAA." Two independent reviewers screened and extracted data. All phase I-III and postmarket evaluation trials that included patients ≥18 years of age, who underwent EVAR were assessed. Participation-to-prevalence ratios (PPRs) were calculated to estimate representation of participants by sex and race/ethnicity in trials compared with their share of disease burden. RESULTS: Among the 4,780 retrieved articles, 55 industry-funded trials met inclusion criteria for this review. A total of 51 trials (93%) reported enrollment by sex/gender, and only 7 trials (13%) reported enrollment by race/ethnicity of the participants. A median of 19 (interquartile range [IQR]: 4.5, 51) women participants were recruited compared to 171 (IQR: 57, 311.5) men, and 17 (IQR: 7.5, 21.5) racial/minority patients were recruited compared to 241 (IQR: 123, 463.5) White participants. Women represent 16.6% of the disease population, and the median PPR is 0.62 (IQR: 0.42, 0.88), which has remained constant over time (Figure 1). None of the device trials reported outcomes based on sex/gender or race/ethnicity. CONCLUSIONS: This systematic review highlights the disparities in recruitment and outcome reporting based on sex and race/ethnicity in EVAR device development trials. While most trials may be underpowered to study these differences, recent registry studies show differential outcomes based on sex and race/ethnicity of vascular patients. Therefore, it is imperative to include and report outcomes in these participants, starting from the initial device development phases to improve generalizability of device-use and understand sources of variation in device performance.

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): A feasibility randomized controlled trial in knee replacement patients.

Background: Total knee arthroplasties are the second most common surgery in Canada. Most patients recover well, but 20% or more still suffer from persistent pain and opioid use. Though opioids are an important part of perioperative pain management, their potential for long-term adverse effects is well recognized. Limiting opioids may be insufficient to overcome the issue of opioid overuse. Pain and opioid use are highly linked, so an effective alternative needs to address both issues. Objectives: The principal objective of this pilot trial is to assess the feasibility. The clinical objectives are to determine the effects of a multicomponent care pathway on opioid-free pain control, persisting pain and opioid use, functional knee outcomes, quality of life, and return to function. Methods: We will include adult patients scheduled for primary elective total knee arthroplasty. Patients in the intervention group will undergo a multicomponent intervention pathway that will be facilitated by an intervention coordinator linking each patient and their surgical/ perioperative team. The interventional pathway will include (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation using cognitive behavioral skills, (3) personalized postdischarge analgesic prescriptions, and (4) continued support for pain control and recovery up to 8 weeks. Patients in the control group will receive the usual care at their institution. Discussion: The overarching goal is to implement and evaluate a coordinated approach to clinical care to improve pain control and reduce harms, with an emphasis on patient-centered care and shared decision making.Trial Registration Number: NCT04968132 (informed consent/ research ethics board statement).

Contexte: L'arthroplastie totale du genou est la deuxième chirurgie la plus courante au Canada. La plupart des patients se rétablissent bien, mais au moins 20 pour cent d'entre eux souffrent encore de douleur persistante et de consommation d'opioïdes. Bien que les opioïdes soient un élément important de la prise en charge périopératoire de la douleur, leur potentiel d'effets indésirables à long terme est bien reconnu. La limitation des opioïdes peut être insuffisante pour surmonter le problème de la surconsommation d'opioïdes. La douleur et la consommation d'opioïdes sont étroitement liées, de sorte qu'une option de rechange efficace doit s'attaquer à ces deux problèmes.Objectifs: L'objectif principal de cet essai pilote est d'évaluer la faisabilité. Les objectifs cliniques sont de déterminer les effets d'une voie de soins à composantes multiples sur la maitrise de la douleur sans opioïdes, la douleur persistante et la consommation d'opioïdes, les résultats fonctionnels du genou, la qualité de vie et le retour à la fonction.Méthodes: Nous inclurons les patients adultes devant subir une arthroplastie primaire totale élective du genou. Les patients du groupe d'intervention seront soumis à une voie d'intervention à composantes multiples qui sera facilitée par un coordonnateur d'intervention reliant chaque patient et son équipe chirurgicale/périopératoire. La voie d'intervention comprendra (1) une éducation préopératoire sur la douleur et la consommation d'opioïdes, (2) la détermination et l'atténuation des risques préopératoires à l'aide de compétences comportementales cognitives, (3) des prescriptions analgésiques personnalisées après la sortie, et (4) un soutien continu pour la maîtrise de la douleur et la récupération pendant une période allant jusqu'à huit semaines. Les patients du groupe témoin recevront les soins habituels à leur établissement.Discussion: L'objectif global est de mettre en œuvre et d'évaluer une approche coordonnée des soins cliniques afin d'améliorer la maitrise de la douleur et réduire les méfaits, en mettant l'accent sur les soins centrés sur le patient et la prise de décision partagée. Numéro d'enregistrement de l'essai : NCT04968132 (consentement éclairé/déclaration du comité d'éthique de la recherche).