Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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DOI：
10.1097/dcr.0b013e318232d4c1
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发表时间：
2011-12-01
影响因子：
3.9
通讯作者：
Krivokapic, Zoran V.
中科院分区：
文献类型：
--
作者：
Gorfine, Stephen R.;Onel, Erol;Krivokapic, Zoran V.
背景技术背景：布比卡因缓释脂质体注射液是布比卡因的一种新型制剂，旨在实现长效术后镇痛。目的：本研究的目的是比较单剂量布比卡因缓释注射液与术中给予安慰剂对痔切除术患者术后镇痛的强度和持续时间。设计：本评价是一项多中心、随机、双盲、平行组、安慰剂对照的3期研究。设置：数据来自格鲁吉亚共和国、波兰和塞尔维亚的13个中心。在这项研究中包括的患者年龄在18至86岁，接受切除痔ectomy.Interventions：所有患者接受单剂量的布比卡因缓释300毫克或安慰剂管理，术中通过伤口浸润。累积疼痛评分通过测量疼痛强度曲线下面积进行评估，直至研究药物给药后72小时。结果：189例患者被随机分配和治疗; 186例完成了研究。布比卡因缓释组的疼痛强度评分明显低于安慰剂组（141.8 vs 202.5，P <0.0001）。布比卡因缓释组在术后12小时（59%）至72小时（28%）内保持无阿片类药物的患者多于安慰剂组（14%和10%; P <0.0008至72小时）。布比卡因缓释组和安慰剂组72小时内阿片类药物的平均总消耗量分别为22.3 mg和29.1 mg（P
BACKGROUND: Bupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.OBJECTIVE: The aim of this study was to compare the magnitude and duration of postoperative analgesia from a single dose of bupivacaine extended-release injection with placebo administered intraoperatively in patients undergoing hemorrhoidectomy.DESIGN: This evaluation was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 study.SETTINGS: Data were obtained from 13 centers in the Republic of Georgia, Poland, and Serbia.PATIENTS: Included in this study were patients aged 18 to 86 years undergoing excisional hemorrhoidectomy.INTERVENTIONS: All patients received either a single dose of bupivacaine extended-release 300 mg or placebo administered intraoperatively via wound infiltration.MAIN OUTCOME MEASURE: The cumulative pain score was assessed by measurement of the area under the curve of pain intensity through 72 hours after study drug administration.RESULTS: One hundred eighty-nine patients were randomly assigned and treated; 186 completed the study. Pain intensity scores were significantly lower in the bupivacaine extended-release group in comparison with the group receiving placebo (141.8 vs 202.5, P < .0001). More patients in the bupivacaine extended-release group remained opioid free from 12 hours (59%) to 72 hours (28%) after surgery compared with patients receiving placebo (14% and 10%; P < .0008 through 72 h). The mean total amount of opioids consumed through 72 hours was 22.3 mg and 29.1 mg in the bupivacaine extended-release and placebo groups (P