Intraoperative intra-articular injection of corticosteroids vs. systemic intra-venous administration vs. no administration in patients undergoing total knee arthroplasty
study protocol of a triple-blind randomized controlled trial
Additional information
Authors
Type
Journal Article
Year
2025
Language
English
Abstract
OBJECTIVE: Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic procedures, although postoperative pain control through the optimization of analgesia protocols remains a key aspect. Corticosteroids (CS) intraoperative administration has been suggested to decrease postoperative pain, reduce the incidence of nausea and vomiting, improve postoperative range of motion, and decrease the systemic inflammatory response, shortening overall hospital stay, and improving patient recovery without increasing the risk of complications. However, the literature still lacks trials directly comparing intra-articular (IA) and intra-venous (IV) steroid administration. The aim of this study is to compare the two delivery approaches to determine if they may yield different results. METHODS AND ANALYSIS: A triple-blind randomized controlled trial (RCT) was designed to investigate the effectiveness of IA (treatment group 1) or IV (treatment group 2) intraoperative CS administration in the immediate postoperative period and up to 10 years of follow-up for patients undergoing TKA, and to compare this to the standard perioperative analgesia protocol without CS administration (control group). The trial uses a 1:1:1 allocation ratio. The aim of this trial is to evaluate the safety and clinical benefit of CS administration, identifying the most suitable delivery approach. The hypothesis is that CS administration could provide superior pain relief in TKA patients, while showing the pros and cons of the administration routes. Secondary outcomes include length of hospital stay, postoperative nausea, opioid consumption, inflammatory response, glycemia, knee range of motion, time to mobilization, and patient-reported outcome measures (PROMs) over time. ETHICS AND DISSEMINATION: The study protocol was approved by the Cantonal Ethical Committee of Ticino, Bellinzona, Switzerland. All participants signed a written informed consent form before taking part in the study. The results of this trial will be disseminated through congress presentations and peer-reviewed publications. CONCLUSIONS: The results of this trial will offer valuable insights into the effect of CS in TKA, evaluating both risks and benefits. The study findings will elucidate the optimal administration route and assess whether the safety and potential benefits of CS administration extend beyond short-term pain improvement, offering longer-lasting advantages for patients undergoing TKA.
Keywords
Arthroplasty, Corticosteroids, Knee, Injection, Protocol, RCT
Journal
Joints
Volume
3
Diffusion
License
CC BY-NC-SA
Visibility
Public
Status open access
Gold
