Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS): A Protocol for a Feasibility Randomized Controlled Trial in Knee Replacement Patients

Abstract

Abstract 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