【罂粟摘要】布比卡因脂质体和盐酸布比卡因与单独使用盐酸布比卡因作为膝关节置换术患者关节周围麻醉药的疗效比较

超过一半接受膝关节置换手术的患者报告术后有严重的急性疼痛。本研究的目的是评价关节周围布比卡因脂质体在膝关节置换术后恢复和疼痛管理中的有效性和成本效益。

这项多中心、患者盲法、实用、随机临床优效性试验涉及英国国家医疗服务体系内 11 个机构的 533 名参与者。在 2018 年 3 月 29 日至 2020 年 2 月 29 日期间招募了因有症状的终末期骨关节炎而接受初次单侧膝关节置换术的成人，并在手术后随访 1 年。随访于 2021 年 3 月 1 日完成。除了主要意向治疗分析外，还对每个共同主要结局进行了符合方案分析。干预措施为手术时关节周围注射266mg布比卡因脂质体混合100mg盐酸布比卡因与单独100mg盐酸布比卡因(对照)。共同主要结果是 72 小时的恢复质量 40 (QoR-40) 评分和 6 至 72 小时的疼痛视觉模拟量表 (VAS) 评分曲线下面积 (AUC)。次要结果包括第 0 天（手术当晚）、第 1、2 和 3 天的 QoR-40 和平均疼痛 VAS；72 小时的累积阿片类药物消耗量；6 周、6 个月和 1 年的功能结果和生活质量；以及 1 年的成本效益。还评估了随机分组后长达 12 个月的不良事件和严重不良事件。

在纳入分析的 533 名参与者中，平均（SD）年龄为 69.0（9.7）岁；287 名患者为女性（53.8%），246 名患者为男性（46.2%）。研究组之间的基线特征平衡。布比卡因脂质体组和对照组在 72 小时的 QoR-40 评分（调整后的平均差异为 0.54 [97.5% CI，-2.05 至 3.13]；P =0 .64）或 6 至 72 小时的疼痛 VAS 评分 AUC（-21.5 [97.5% CI，-46.8 至 3.8]；P =0 .06）方面没有差异。疼痛 VAS 和 QoR-40 评分分析仅显示 1 个统计学上显着差异，布比卡因脂质体组在手术当晚的疼痛评分较低（调整差异 -0.54 [97.5% CI，-1.07 至 -0.02]；P =0 .02）。未发现累积阿片类药物消耗和功能结果的差异。与对照治疗相比，布比卡因脂质体不具成本效益。布比卡因脂质体组和对照组之间在不良或严重不良事件方面无差异。

本研究发现，在接受膝关节置换手术的患者中，关节周围使用布比卡因脂质体与单独使用盐酸布比卡因相比，术后恢复或疼痛无差异。

原始文献来源：Thomas W. Hamilton,Ruth Knight,Jamie R. Stokes, et al. Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement. JAMA Surgery. 2022;157 (6):481-481. doi:10.1001/jamasurg.2022.0713

Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement A Randomized Clinical Trial

MPORTANCE More than half of patients who undergo knee replacement surgery report substantial acute postoperative pain.

OBJECTIVE To evaluate the efficacy and cost-effectiveness of periarticular liposomal bupivacaine for recovery and pain management after knee replacement.

DESIGN, SETTING, AND PARTICIPANTS This multicenter, patient-blinded, pragmatic,randomized clinical superiority trial involved 533 participants at 11 institutions within the National Health Service in England. Adults undergoing primary unilateral knee replacement for symptomatic end-stage osteoarthritis were enrolled between March 29, 2018, and February 29, 2020, and followed up for 1 year after surgery. Follow-up was completed March 1, 2021. A per-protocol analysis for each coprimary outcome was performed in addition to the main intention-to-treat analysis.

INTERVENTIONS Two hundred sixty-six milligrams of liposomal bupivacaine admixed with 100 mg of bupivacaine hydrochloride compared with 100 mg of bupivacaine hydrochloride alone (control) administered by periarticular injection at the time of surgery.

MAIN OUTCOME AND MEASURES The coprimary outcomes were Quality of Recovery 40 (QoR-40) score at 72 hours and pain visual analog scale (VAS) score area under the curve (AUC) from 6 to 72 hours. Secondary outcomes included QoR-40 and mean pain VAS at days 0 (evening of surgery), 1, 2, and 3; cumulative opioid consumption for 72 hours; functional outcomes and quality of life at 6 weeks, 6 months, and 1 year; and cost-effectiveness for 1 year. Adverse events and serious adverse events up to 12 months after randomization were also assessed.

RESULTS Among the 533 participants included in the analysis, the mean (SD) age was 69.0 (9.7) years; 287 patients were women (53.8%) and 246 were men (46.2%). Baseline characteristics were balanced between study groups. There was no difference between the liposomal bupivacaine and control groups in QoR-40 score at 72 hours (adjusted mean difference, 0.54 [97.5% CI, −2.05 to 3.13]; P = 0.64) or the pain VAS score AUC at 6 to 72 hours (−21.5 [97.5% CI, −46.8 to 3.8]; P = 0.06). Analyses of pain VAS and QoR-40 scores

demonstrated only 1 statistically significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (adjusted difference −0.54 [97.5% CI, −1.07 to −0.02]; P =0.02). No difference in cumulative opioid consumption and functional outcomes was detected. Liposomal bupivacaine was not cost-effective compared with the control treatment. No difference in adverse or serious adverse events was found between the liposomal bupivacaine and control groups.

CONCLUSIONS AND RELEVANCE This study found no difference in postoperative recovery or pain associated with the use of periarticular liposomal bupivacaine compared with bupivacaine hydrochloride alone in patients who underwent knee replacement surgery.