Would High-Dose Corticosteroid Adjuvant To Multimodal Cocktail Periarticular Injection Contribute To Prolonged Pain Control and Better Recovery After Total Knee Arthroplasty?: Study Protocol for a Double-Blinded, Randomized, and Placebo-Controlled Trial

Abstract

Background Enhanced recovery after total knee arthroplasty (TKA) has been suggested to enhance postoperative recovery. The use of multimodal cocktail periarticular injection (MCPI) to control the pain of TKA has gained wide acceptance. MCPI containing corticosteroids is believed to be an effective solution because of its local anti-inflammatory effects and ability to reduce the local stress response postoperatively. However, there is conflicting evidence about its benefits. This trial aims to compare MCPI containing a high dose of corticosteroid, MCPI containing anormal dose of corticosteroid, and MCPI without a corticosteroid during TKA to assess the effectiveness of MCPI containing corticosteroid in postoperative pain relief, functional improvement, rescue analgesia and side effects. This will provide evidence regarding the effectiveness of high-dose corticosteroids on prolonged pain control and better recovery after total knee arthroplasty. Methods/design This trial is a double-blinded randomized, placebo-controlled study. A total of 234 patients will be randomized into 3 groups to receive a high dose of betamethasone MCPI (group H), a normal dose of betamethasone MCPI (group N), and a nonbetamethasone MCPI (group C). the following indexes will be recorded and analyzed: knee pain at rest and bending at 90° at 6 h, 24 h, 48 h, 72 h, 5 days, 14 days, and 30 days after surgery; 1-minute walking ability and circumference around patella at 2, 4, 7, 14, and 30 days after surgery; HSS score at 14 and 30 days after surgery; C-reactive protein and blood sedimentation as well as blood sugar at 2, 4, 7, 14, 30 days after surgery; additional morphine analgesics consumption; and side effects. Discussion The results from this study will provide clinical evidence on the effectiveness of MCPI-containing corticosteroids in postoperative pain relief, functional improvement, rescue analgesia, and side effects as well as evidence on the efficacy of high-dose corticosteroids for leading to prolonged pain control and better recovery after TKA. Trial registration Chinese Clinical Trial Registry ChiCTR2000038671. Registered on 27 September 2020