Salmons Harold I, Amundson Adam W, Duncan Christopher M, Larson Dirk R, Mallinger Benjamin D, Couch Cory G, Pagnano Mark W, Trousdale Robert T, Abdel Matthew P
Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.
Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.
J Bone Joint Surg Am. 2025 Jul 25;107(17):1918-1925. doi: 10.2106/JBJS.25.00086.
The U.S. Food and Drug Administration has approved a bupivacaine and meloxicam extended-release (ER) intra-articular injection for pain during total knee arthroplasty (TKA). However, the real-world evidence with regard to analgesic efficacy of that medication has been limited. This randomized clinical trial investigated the efficacy of this new medication compared with our standard periarticular injection for postoperative analgesia after primary TKA.
Eligible patients undergoing primary, unilateral TKA for osteoarthritis at our academic center were enrolled. Patients were blinded and were randomized 1:1 to the bupivacaine-meloxicam ER (ZYNRELEF) injection group or the standard injection (ropivacaine, ketorolac, epinephrine) control group. A standardized, multimodal analgesic pathway was implemented. Numeric Rating Scale (NRS) pain scores and tallies of opioid consumption were collected. The primary outcome was the area under the curve (AUC) for NRS pain, adjusted for opioid consumption, over 72 hours. The minimal clinically important difference was considered to be 30%. Power analysis determined a minimum of 44 patients per group. The final groups included 53 patients in the experimental group and 48 patients in the control group.
Similar postoperative analgesia was observed, with an AUC for the adjusted NRS pain score up to 72 hours of 331 in the experimental group and 373 in the control group (p = 0.09). The mean maximum NRS pain scores were similar and reflected good, but not complete, analgesia. Scores were 3 to 5 on the day of the surgery, 4 to 6 on postoperative day (POD) 1, 5 to 6 on POD 2, and 4 to 5 on POD 3 (p > 0.05). One patient in the experimental group and 2 patients in the control group had early postoperative complications, none of which was deemed to be related to the analgesic choice.
This randomized clinical trial demonstrated similar analgesia with a bupivacaine-meloxicam ER solution and a standard periarticular injection up to 72 hours after primary TKA. Cost, reimbursement, and convenience may ultimately prove to be more important than analgesic differences when choosing between these 2 effective options for managing postoperative pain.
Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
美国食品药品监督管理局已批准一种布比卡因和美洛昔康缓释关节内注射剂用于全膝关节置换术（TKA）期间的疼痛治疗。然而，关于该药物镇痛效果的真实世界证据有限。这项随机临床试验研究了这种新药与我们标准的关节周围注射剂相比，在初次全膝关节置换术后的镇痛效果。
在我们的学术中心，纳入符合条件的因骨关节炎接受初次单侧全膝关节置换术的患者。患者被设盲，并按1:1随机分为布比卡因 - 美洛昔康缓释（ZYNRELEF）注射组或标准注射（罗哌卡因、酮咯酸、肾上腺素）对照组。实施标准化的多模式镇痛方案。收集数字评分量表（NRS）疼痛评分和阿片类药物消耗量记录。主要结局是调整阿片类药物消耗量后，72小时内NRS疼痛曲线下面积（AUC）。最小临床重要差异被认为是30%。功效分析确定每组至少44例患者。最终试验组有53例患者，对照组有48例患者。
观察到相似的术后镇痛效果，试验组调整后的NRS疼痛评分至72小时的AUC为（此处原文有误，应为331），对照组为373（p = 0.09）。平均最大NRS疼痛评分相似，反映出良好但不完全的镇痛效果。手术当天评分为3至5分，术后第1天（POD1）为4至6分，POD2为5至6分，POD3为4至5分（p > 0.05）。试验组有1例患者和对照组有2例患者出现早期术后并发症，均被认为与镇痛选择无关。
这项随机临床试验表明，在初次全膝关节置换术后72小时内，布比卡因 - 美洛昔康缓释溶液和标准关节周围注射的镇痛效果相似。在这两种有效管理术后疼痛的选择之间进行抉择时，成本、报销和便利性最终可能比镇痛差异更为重要。
治疗水平I。有关证据水平的完整描述，请参阅作者指南。
Zotero 插件