Background Enhanced recovery following total knee arthroplasty (TKA) has been advocated to enhance postoperative recovery. Multimodal cocktail periarticular injection (MCPI) use for pain control in TKA has gained wide acceptance. MCPI-containing corticosteroids are believed to be an effective solution owing to their local anti-inflammatory effects and ability to reduce the local stress response postoperatively. However, there is conflicting evidence regarding its benefits. This trial aims to compare MCPI with a high dose of corticosteroid, normal dose of corticosteroid, and non-corticosteroid during TKA, to assess the effectiveness of MCPI containing corticosteroids in postoperative pain relief, functional improvement, rescue analgesia, and side effects and provide evidence that high-dose corticosteroids result in prolonged pain control and better recovery following TKA. Methods This is a double-blinded, randomized, placebo-controlled study. A total of 234 patients scheduled for TKA will be recruited. During surgery, before wound closure, 80 ml of the cocktail analgesic will be injected into the muscle and joint capsule for local infiltration analgesia; the participants will be randomly assigned to three groups to receive a high dose of betamethasone MCPI (group H), normal dose of betamethasone MCPI (group N), and non-betamethasone MCPI (group C). The following indices will be recorded and analyzed: the strongest knee pain experienced during 90° flexion at 6 h, 24 h, 48 h, 72 h, 5 days, 14 days, and 30 days after surgery; 1 min walking ability; and circumference around the patella at 2, 5, 14, and 30 days after surgery; Knee Society knee score at 14 days and 30 days after surgery; C-reactive protein and blood sedimentation; blood sugar 2, 5, 14, and 30 days following surgery; rescue analgesic consumption; and adverse events. If any participant withdraws from the trial, an intention-to-treat analysis will be performed. Discussion The results of this study will provide clinical evidence on the effectiveness of MCPI-containing corticosteroids in postoperative pain relief, functional improvement, rescue analgesia, and adverse events, as well as provide evidence on the efficacy of high-dose corticosteroids in prolonged pain control and better recovery following TKA. Trial registration Chinese Clinical Trial Registry, ChiCTR2000038671. Registered on September 27, 2020.
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
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