Template protocol for randomized clinical trials on reducing long-term postoperative opioid use

Summary The global opioid crisis underscores the critical need for interventions to reduce prolonged opioid use after surgery. This article provides a structured template for randomized clinical trials designed to evaluate strategies aimed at minimizing long-term postoperative opioid use. Elements of the protocol include inclusion and exclusion criteria, intervention specifications, primary and secondary outcomes, randomization and data collection methods, and statistical analysis plans. Adverse drug reactions, which can range from mild side effects, such as nausea, constipation, and drowsiness, to severe health complications including respiratory depression, dependency, and overdose, are a significant concern with prolonged opioid use. By offering a framework, this template aims to guide clinical researchers in designing clinical trials that address long-term opioid overuse, reduce adverse drug reactions, and enhance postoperative care.