Department of Orthopedic Surgery, People's Hospital of Gaozhou, No. 89, Xiguan Road, Gaozhou City, 525200, Guangdong, China.
Department of Orthopedic Surgery, Maoming People's Hospital, No.101, Weimin Road, Maoming City, 525000, Guangdong, China.
Trials. 2021 Oct 15;22(1):703. doi: 10.1186/s13063-021-05655-1.
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.
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.
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.
Chinese Clinical Trial Registry, ChiCTR2000038671 . Registered on September 27, 2020.
全膝关节置换术（TKA）后提倡增强康复，以促进术后恢复。关节周围注射多模式鸡尾酒（MCPI）用于 TKA 的疼痛控制已得到广泛认可。含有皮质类固醇的 MCPI 因其局部抗炎作用和减少术后局部应激反应的能力而被认为是一种有效的解决方案。然而，其益处存在相互矛盾的证据。本试验旨在比较 TKA 中 MCPI 与高剂量皮质类固醇、低剂量皮质类固醇和非皮质类固醇的效果，评估含有皮质类固醇的 MCPI 在术后止痛、功能改善、解救性镇痛和副作用方面的有效性，并提供高剂量皮质类固醇可延长 TKA 后疼痛控制和更好恢复的证据。
这是一项双盲、随机、安慰剂对照研究。共招募 234 例计划行 TKA 的患者。手术中，在关闭切口前，将 80ml 鸡尾酒镇痛剂注入肌肉和关节囊进行局部浸润镇痛；参与者将随机分为三组，接受高剂量倍他米松 MCPI（组 H）、低剂量倍他米松 MCPI（组 N）和非倍他米松 MCPI（组 C）。记录和分析以下指标：术后 6h、24h、48h、72h、5d、14d 和 30d 时膝关节 90°屈曲时经历的最强膝关节疼痛；1min 步行能力；术后 2d、5d、14d 和 30d 时髌骨周围周长；术后 14d 和 30d 的膝关节协会膝关节评分；C 反应蛋白和血沉降；术后 2d、5d、14d 和 30d 时的血糖；解救性镇痛消耗；以及不良事件。如果任何参与者退出试验，将进行意向治疗分析。
本研究结果将提供 MCPI 中含有皮质类固醇在术后止痛、功能改善、解救性镇痛和不良事件方面有效性的临床证据，并提供高剂量皮质类固醇在 TKA 后延长疼痛控制和更好恢复方面的疗效证据。
中国临床试验注册中心，ChiCTR2000038671 。注册于 2020 年 9 月 27 日。
