Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
University Orthopedic and Joint Replacement Center, Tamarac, Florida.
J Knee Surg. 2023 Jul;36(9):925-932. doi: 10.1055/s-0042-1747945. Epub 2022 Jun 10.
Total knee arthroplasty (TKA) can be associated with significant postoperative pain despite multimodal analgesic (MMA) protocols, and most patients require the use of opioids postoperatively. HTX-011 is a dual-acting local anesthetic containing bupivacaine and low-dose meloxicam in an extended-release polymer. In a prior randomized controlled trial (RCT), HTX-011 reduced pain and opioid use through 72 hours after TKA compared with bupivacaine hydrochloride. This open-label study (NCT03974932) evaluated the efficacy and safety of HTX-011 combined with an MMA regimen in patients undergoing TKA under spinal anesthesia. All patients received intraoperative HTX-011 (400 mg bupivacaine/12 mg meloxicam) in combination with an MMA regimen consisting of preoperative acetaminophen, celecoxib, and pregabalin and postoperative acetaminophen and celecoxib until discharge. Opioid rescue was allowed upon patient request for additional pain control. Pain scores, opioid consumption, discharge readiness, and adverse events were recorded. Fifty-one patients were treated. Compared with the prior RCT, HTX-011 with this MMA regimen further lowered pain scores and reduced opioid use. Mean patient-reported pain scores remained in the mild range, and 82% of patients or more did not experience severe pain at any individual time point through 72 hours after surgery. Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day). Approximately 60% of patients were ready for discharge by 12 hours, and 39% were discharged without an opioid prescription and did not call back for pain management. The treatment regimen was well tolerated, and no added risk was observed with the addition of MMA. HTX-011 with an MMA regimen reduced postoperative pain and opioid use following TKA.
全膝关节置换术（TKA）尽管采用了多模式镇痛（MMA）方案，但仍可能出现明显的术后疼痛，大多数患者术后需要使用阿片类药物。HTX-011 是一种双重作用的局部麻醉剂，包含布比卡因和小剂量美洛昔康，采用延长释放聚合物。在先前的一项随机对照试验（RCT）中，与盐酸布比卡因相比，HTX-011 在 TKA 后 72 小时内可减轻疼痛并减少阿片类药物的使用。这项开放标签研究（NCT03974932）评估了 HTX-011 联合 MMA 方案在椎管内麻醉下接受 TKA 的患者中的疗效和安全性。所有患者均接受术中 HTX-011（400mg 布比卡因/12mg 美洛昔康）联合 MMA 方案治疗，该方案包括术前使用对乙酰氨基酚、塞来昔布和普瑞巴林，术后使用对乙酰氨基酚和塞来昔布直至出院。如果患者需要额外的疼痛控制，可以使用阿片类药物进行解救。记录了疼痛评分、阿片类药物的消耗、出院准备情况和不良事件。51 例患者接受了治疗。与之前的 RCT 相比，该 MMA 方案联合 HTX-011 进一步降低了疼痛评分并减少了阿片类药物的使用。患者报告的平均疼痛评分仍处于轻度范围，82%以上的患者在术后 72 小时内任何单个时间点均未出现严重疼痛。72 小时内总的阿片类药物消耗较低：24.8 吗啡毫克当量（1-2 片每天 10mg 羟考酮）。约 60%的患者在 12 小时时准备出院，39%的患者出院时未开具阿片类药物处方，也未因疼痛管理而回诊。该治疗方案耐受良好，与添加 MMA 相比，未观察到额外的风险。TKA 后，MMA 方案联合 HTX-011 可减轻术后疼痛并减少阿片类药物的使用。
