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

• Published in: Acta anaesthesiologica Scandinavica 2020-10, Vol.64 (9), p.1350-1356
• Main Authors: Nielsen, Niklas I., Kehlet, Henrik, Gromov, Kirill, Troelsen, Anders, Husted, Henrik, Varnum, Claus, Kjærsgaard‐Andersen, Per, Rasmussen, Lasse E., Mandøe, Hans, Foss, Nicolai B.
• Format: Article
• Language: English
• Subjects: Analgesics; Antiemetics; Arthroplasty (knee); Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Biomedical materials; Clinical trials; Dexamethasone; Glucocorticoids; Humans; Intravenous administration; Joint surgery; Knee; Morbidity; Morphine; Narcotics; Opioids; Pain; Pain, Postoperative - drug therapy; Patients; Randomization; Randomized Controlled Trials as Topic; Sleep; Steroid hormones; Steroids; Subgroups; Subpopulations; Surgery; Surgical implants; Total hip arthroplasty
• ISSN: 0001-5172; 1399-6576
• DOI: 10.1111/aas.13656

Background Patients undergoing total knee arthroplasty (TKA)/ total hip arthroplasty (THA) still experience moderate‐severe postoperative pain despite optimized pain management regimes. The 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 were 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. In total, 408 patients were 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 completed follow‐up on day 90. Recruiting commenced February 2019 and is expected to finish in September 2020.