Jiang Xiping, Xu Cheng, Yuan Chenrui, Gao Wenliang, Liu Wencai, Wang Yifei, Wang Haiming, Yu Weilin, He Yaohua
Department of Orthopedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, People's Republic of China.
Department of Anesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, People's Republic of China.
J Pain Res. 2025 Jan 20;18:259-270. doi: 10.2147/JPR.S497297. eCollection 2025.
Arthroscopic rotator cuff repair (ARCR) commonly results in significant postoperative pain. Adjuncts like dexamethasone (DEX) and tranexamic acid (TXA) are used to enhance postoperative recovery. This study aimed to determine whether the combined application of TXA and DEX could improve postoperative recovery during the first 24 hours in ARCR patients. Our goal is to relieve the acute postoperative pain and promote fast recovery and rapid discharge for ARCR patients.
Ninety-six patients who underwent ARCR from December 2023 to March 2024 were enrolled in this double-blinded, randomized control trial (Registration number, ChiCTR2300078507). Patients were randomized to intravenously receive 200mL of normal saline (control group), 200mL of 1g TXA in saline (TXA group), or 200 mL of 1g TXA and 5mg DEX in saline (TXA+DEX group) within 2 hours postoperatively. The primary outcome was the Quality of Recovery-15 (QoR-15) score at 24 hours post-surgery. Secondary outcomes included mean visual analog scale (VAS) scores every four hours within 24 hours, postoperative blood test results the day after surgery, and American Shoulder and Elbow Surgeons (ASES) score at 3 months postoperatively.
No significant differences in QoR-15 scores at 24 hours were observed among the groups [control, 127.0 (112.8, 138.0); TXA, 125.0 (116.5, 136.8); TXA+DEX, 132.0 (120.3, 140.8), p = 0.176]. VAS scores at 5-8 (placebo vs TXA+DEX, p = 0.014; TXA vs TXA+DEX, p = 0.002), 9-12 (placebo vs TXA+DEX, p = 0.008; TXA vs TXA+DEX, p < 0.001), and 13-16 (placebo vs TXA+DEX, p = 0.035; TXA vs TXA+DEX, p = 0.013) hours postoperatively showed a significant decrease for the TXA+DEX group compared with the control or TXA group. There were no significant differences in postoperative blood test results and ASES score at 3 months postoperatively.
Postoperative application of TXA alone could not facilitate postoperative recovery during the first 24 hours in ARCR patients. Although the combination of TXA and DEX presented better levels of postoperative pain between 5 and 16 hours than the control and TXA alone, it did not significantly improve postoperative recovery quality. Further large-scale and multi-center investigation is required to determine if the combined application of TXA and DEX or TXA alone is beneficial for postoperative recovery in ARCR patients.
关节镜下肩袖修复术(ARCR)术后通常会出现明显疼痛。地塞米松(DEX)和氨甲环酸(TXA)等辅助药物用于促进术后恢复。本研究旨在确定TXA和DEX联合应用是否能改善ARCR患者术后24小时内的恢复情况。我们的目标是缓解ARCR患者术后急性疼痛,促进快速恢复并实现快速出院。
本双盲随机对照试验纳入了2023年12月至2024年3月接受ARCR的96例患者(注册号,ChiCTR2300078507)。患者术后2小时内随机静脉输注200mL生理盐水(对照组)、200mL含1g TXA的生理盐水(TXA组)或200mL含1g TXA和5mg DEX的生理盐水(TXA + DEX组)。主要结局是术后24小时的恢复质量-15(QoR-15)评分。次要结局包括术后24小时内每4小时的平均视觉模拟量表(VAS)评分、术后次日的血液检查结果以及术后3个月的美国肩肘外科医师(ASES)评分。
各组术后24小时的QoR-15评分无显著差异[对照组,127.0(112.8,138.0);TXA组,125.0(116.5,136.8);TXA + DEX组,132.0(120.3,140.8),p = 0.176]。术后5 - 8小时(安慰剂组与TXA + DEX组,p = 0.014;TXA组与TXA + DEX组,p = 0.002)、9 - 12小时(安慰剂组与TXA + DEX组,p = 0.008;TXA组与TXA + DEX组,p < 0.001)和13 - 16小时(安慰剂组与TXA + DEX组,p = 0.035;TXA组与TXA + DEX组,p = 0.013)的VAS评分显示,TXA + DEX组与对照组或TXA组相比显著降低。术后血液检查结果和术后3个月的ASES评分无显著差异。
单独应用TXA不能促进ARCR患者术后24小时内的恢复。尽管TXA和DEX联合应用在术后5至16小时的疼痛程度优于对照组和单独使用TXA,但并未显著改善术后恢复质量。需要进一步进行大规模多中心研究,以确定TXA和DEX联合应用或单独应用TXA是否对ARCR患者术后恢复有益。