Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.
Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.
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标准局麻药布比卡因和布比卡因脂质体用于躯干切口患者术后疼痛控制的有效性：一项随机临床试验。
DOI：
10.1001/jamanetworkopen.2021.0753
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发表时间：
2021-03-01
影响因子：
13.8
通讯作者：
Charlton-Ouw KM
中科院分区：
文献类型：
--
作者：
Sandhu HK;Miller CC 3rd;Tanaka A;Estrera AL;Charlton-Ouw KM
在心胸和血管外科患者中，布比卡因脂质体是否比标准布比卡因更能减少术后疼痛和补充阿片类药物的使用？在这项包括280名参与者的随机临床试验中，观察到脂质体与标准制剂布比卡因之间在疼痛控制方面没有显著差异。这些结果不支持脂质体布比卡因在心胸和血管干切口术后疼痛控制方面优于布比卡因的上级性能。这项随机临床试验研究了脂质体布比卡因与标准布比卡因对心胸或血管手术躯干切口患者术后疼痛的有效性。用于止痛的脂质体布比卡因据称持续3天，而标准布比卡因持续8小时。然而，它的有效性是未知的，在躯干切口心胸或血管手术。比较标准布比卡因与布比卡因脂质体单次给药在躯干切口患者中的有效性。这项随机临床试验入组了2012年11月至2018年6月期间在一家学术医疗中心的单一心血管外科接受胸骨切开术、开胸术、小切口开胸术和剖腹术的患者。该研究的功效是检测科恩效应量为0.35，功效大于80%。数据分析于2018年7月至12月进行。患者随机接受标准布比卡因或布比卡因脂质体。术后3天内通过数字评定量表（NRS）评估疼痛。将辅助阿片类药物转换为吗啡当量单位（MEU）。使用Wilcoxon秩和（3天曲线下面积）和双向非参数混合模型（每日量表评分）比较NRS评分，以评估时间与组的相互作用。次要结果包括累积阿片类药物消耗量。共分析了280例患者，每组140例（单次给药标准布比卡因与脂质体布比卡因）。平均（SD）年龄为60.2（14.4）岁，280例患者中有101例（36%）为女性。不考虑治疗分配，3天内疼痛平均每天减少约1分（β =-0.87; SE = 0.11;混合模型回归P < .001）。切口类型与开胸手术患者的疼痛相关（包括小切口开胸术）报告的中位数最高术后第1天的（四分位距[IQR]）疼痛评分（脂质体vs标准布比卡因，6 [4-8] vs 5 [3-7]; P = .049，Wilcoxon秩和）和2（脂质体vs标准布比卡因，5 [4-7] vs 4 [2-6]; P = .003，Wilcoxon秩和），但第3天（脂质体vs标准布比卡因，3 [2-6] vs 3 [1-5]; P = .10，Wilcoxon秩和）未发生变化，与治疗组无关。中位（IQR）3天累积NRS为12.0布比卡因为8.0-16.5，（9.0-17.0）对于布比卡因脂质体（P = .15，Wilcoxon秩和）此外，与标准布比卡因相比，脂质体布比卡因后阿片类药物的使用量更大。（中位数[IQR]，41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = 0.03，Wilcoxon秩和）。在多变量分析中，未观察到切口类型与平均疼痛评分或阿片类药物使用之间的相互作用。在这项涉及心血管手术躯干切口的随机临床试验中，与传统布比卡因制剂相比，脂质体布比卡因在术后3天内没有改善疼痛控制，也没有减少阿片类药物的连续使用。ClinicalTrials.gov标识符：NCT 02111746
Does liposomal bupivacaine reduce postoperative pain and supplemental opioid use more than standard bupivacaine in cardiothoracic and vascular surgical patients? In this randomized clinical trial including 280 participants, no significant difference in pain control was observed between liposomal vs standard formulation bupivacaine. These results do not support superior performance of liposomal bupivacaine compared with bupivacaine for postoperative pain control in cardiothoracic and vascular truncal incisions. This randomized clinical trial investigates the effectiveness of liposomal bupivacaine vs standard bupivacaine for postoperative pain in patients with truncal incisions for cardiothoracic or vascular procedures. Liposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations. To compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions. This randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018. Patients were randomized to standard bupivacaine or liposomal bupivacaine. Pain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption. A total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (β = −0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use. In this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days. ClinicalTrials.gov Identifier: NCT02111746
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