Abstract
BackgroundEnhanced 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.MethodsThis 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.DiscussionThe 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 registrationChinese Clinical Trial Registry, ChiCTR2000038671. Registered on September 27, 2020.
Highlights
MethodsThis is a double-blinded, randomized, placebo-controlled study. A total of 234 patients scheduled for total knee arthroplasty (TKA) will be recruited
Background and rationale {6a} Total knee arthroplasty (TKA) has been reported to be the most effective procedure for pain relief in patients with advanced osteoarthritis
Corticosteroid addition to Multimodal cocktail periarticular injection (MCPI) is believed to be a key component owing to its local antiinflammatory effects and ability to reduce the local stress response following surgery
Summary
Study setting {9} This trial has been approved by the ethics committee of The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (approval number: ZF2020-031-01). Recruitment {15} Patients scheduled for TKA from the Department of Orthopedics, Second Affiliated Hospital, Guangzhou University of Chinese Medicine will be screened by the research team for participation based on the inclusion and exclusion criteria listed above Those who satisfy the inclusion criteria and are willing to participate in this experiment will be provided details about study treatment, follow-up, and contact details for further information. Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} Any important protocol modifications, including the principal investigator, informed consent form, study protocol regarding eligibility criteria, outcomes, and analyses, will be reported to all investigators, Trial Steering Committee, trial participants, trial registry, and ethics committee of the Second Affiliated Hospital, Guangzhou University of Chinese Medicine.
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