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 randomized controlled trial using a 2-arm parallel group design. 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; 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 inform implementation of a coordinated approach, integrating a multicomponent pain pathway to improve pain control and reduce harms, while keeping an emphasis on patient centered care and shared decision making. Trial Registration: Prospectively registered in clinicaltrials.gov (NCT04968132) on 21 July 2021. https://clinicaltrials.gov/ct2/show/NCT04968132
Background: Osteoarthritis (OA) is one of the most common degenerative joint diseases that occurs in the elderly population. Total knee arthroplasty is a recognized treatment for end-stage knee OA and is effective in managing pain and improving function. However, postoperative pain and opioid use continue to be major challenges. Clinical trials aiming to study interventions to decrease these twin challenges have used different priorities and varied approaches to measure and report pain and opioid use as clinical outcomes. The purpose of this study is to methodologically review randomized controlled trials on total knee arthroplasties to describe and report the approach to measuring pain and opioid use. Because pain and opioid use are interrelated concepts that, we argue, should not be conceptually separated, we will particularly focus on whether and how pain and opioid use are reported as either a combined outcome or as co-primary outcomes.Methods: This is a protocol for a methodological review of pain and opioid use outcomes used in knee arthroplasty RCTs published in the past 10 years (Jan 1, 2012 – Oct 1, 2022). Eligible studies will be identified by searching MEDLINE, EMBASE, and CENTRAL databases. A systematic review management software, Covidence, will be used to conduct the screening and data extraction stages of the study. Screening and data extraction will be done individually and in duplicate for study inclusion and final analysis. Discussion: Previous studies have outlined potential analytical approaches to combine and report pain scores and opioid use as either co-primary outcomes or one outcome, but no consensus has been reached in the reporting of these two outcomes. This study will add to the literature by methodologically evaluating the literature on pain and opioid use outcomes following a total knee arthroplasty and describe how these two outcomes are reported, with a particular focus on whether and how they are reported as one combined outcome or co-primary outcomes.
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