Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.
Department of Orthopaedic Surgery, OrthoCarolina Hip & Knee Center, Charlotte, North Carolina.
J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
Local infiltration analgesia (LIA) with liposomal bupivacaine (LB) in patients undergoing total knee arthroplasty (TKA) has yielded mixed results. The PILLAR study, which was designed to minimize limitations associated with previous studies, compared the effects of LIA with or without LB on pain scores, opioid consumption, including proportion of opioid-free patients, time to first opioid rescue, and safety after primary unilateral TKA.
Patients (N = 140) were randomized to LIA with LB 266 mg/20 mL (admixed with bupivacaine HCl 0.5%, 20 mL) or LIA with bupivacaine HCl 0.5%, 20 mL. Standardized infiltration techniques and a standardized multimodal pain management protocol were used. The coprimary efficacy endpoints were area under the curve (AUC) of visual analog scale pain intensity scores 12-48 hours (AUC) postsurgery and total opioid consumption 0-48 hours postsurgery.
Mean AUC of visual analog scale pain intensity score was 180.8 with LB and 209.3 without LB (least squares [LS] mean treatment difference -26.88, P = .0381). LS mean total opioid consumption 0-48 hours postsurgery was 18.7 mg with and 84.9 mg without LB (LS ratio 0.220, P = .0048). Significant differences in favor of LB were observed for the percentage of opioid-free patients (P < .01) and time to first opioid rescue (P = .0230). Treatments were similarly well tolerated.
This study provides data on LIA with LB administered using optimal techniques specific to TKA. In this setting, LIA with LB significantly improved postsurgical pain, opioid consumption, and time to first opioid rescue, with more opioid-free patients and no unexpected safety concerns.
在全膝关节置换术(TKA)患者中,局部浸润镇痛(LIA)联合包载布比卡因的脂质体(LB)的效果喜忧参半。PILLAR 研究旨在最大限度地减少以往研究的局限性,该研究比较了 LIA 联合 LB 与 LIA 联合布比卡因盐酸盐(0.5%,20mL)对疼痛评分、阿片类药物消耗(包括无阿片类药物患者的比例)、首次阿片类药物解救时间和单侧初次 TKA 后的安全性的影响。
将 140 名患者随机分为 LIA 联合 LB(266mg/20mL,与 0.5%布比卡因盐酸盐 20mL 混合)或 LIA 联合布比卡因盐酸盐(0.5%,20mL)。采用标准化的浸润技术和标准化的多模式疼痛管理方案。主要疗效终点为术后 12-48 小时视觉模拟评分(VAS)疼痛强度曲线下面积(AUC)和术后 0-48 小时阿片类药物总消耗量。
LB 的 VAS 疼痛强度评分 AUC 平均值为 180.8,无 LB 的 AUC 平均值为 209.3(最小二乘[LS]平均治疗差异-26.88,P=0.0381)。术后 0-48 小时阿片类药物总消耗量 LS 均值分别为 18.7mg 和 84.9mg(LS 比值 0.220,P=0.0048)。LB 组在无阿片类药物患者的比例(P<0.01)和首次阿片类药物解救时间(P=0.0230)方面有显著的优势。两种治疗方法均具有良好的耐受性。
本研究提供了在 TKA 中采用特定技术的 LB 进行 LIA 的数据。在这种情况下,LIA 联合 LB 可显著改善术后疼痛、阿片类药物消耗和首次阿片类药物解救时间,且无阿片类药物患者比例更高,无意外安全性问题。