Preoperative high-dose Steroids in Total Knee and Hip Arthroplasty - Protocols for three randomized controlled trials.

BACKGROUND Patients undergoing total knee arthroplasty (TKA) / total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes. Patients already on opioid-treatment, and pain catastrophizers (PCs) have a higher risk of postoperative pain. The use of preoperative intravenous high-dose glucocorticoids decreases postoperative pain after TKA and THA, but optimal dose is yet to be found, and the effect on subpopulations at high pain risk is unknown. AIM To investigate the effect of a higher than previously used dose of glucocorticoids (dexamethasone (DXM)), administered intravenously before surgery, as part of standardized fast-track regimen, on postoperative pain in TKA/THA subgroups. METHOD Three separate randomized, double-blinded, controlled trials are planned to compare a new higher dose DXM (1 mg/kg) to the earlier used high-dose DXM (0.3 mg/kg). Study 1: predicted Low Pain TKA; study 2: predicted High Pain Responder (HPR) TKA; study 3: predicted HPR THA. Predicted HPR groups consist of either PCs with PCS-score of ≥21 and/or history of ongoing opioid-treatment of 30 mg/day of morphine or equivalents >30 days. 408 patients in total are planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA). PRIMARY OUTCOME Pain upon ambulation in a 5-meter walk test 24 hours after surgery. Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality. Patients are completed for follow-up on day 90. Recruiting commenced February 2019 and is expected to finish September 2020.