...
首页> 外文期刊>ANZ journal of surgery >Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial
【24h】

Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial

机译:布比卡因缓释局部麻醉在开放性疝修补术中的安全性和有效性:一项随机对照试验

获取原文
获取原文并翻译 | 示例
           

摘要

Background: Pain relief remains a major problem in hernia surgery. SABER-Bupivacaine is an investigational extended-release formulation of bupivacaine in a resorbable matrix, which may provide up to 72 h of local pain relief. Methods: A double-blinded, randomized controlled trial was undertaken to evaluate the safety and efficacy of SABER-Bupivacaine. Consented patients (n = 124) undergoing open inguinal hernia repair at five sites in Australia and New Zealand were randomized to receive either 2.5 (330 mg) or 5.0 mL (660 mg) of SABER-Bupivacaine or SABER-Placebo administered to the surgical wound at the end of the procedure. Analgesic efficacy and safety was evaluated.Results: SABER-Bupivacaine appeared safe with no difference in the incidence of side effects compared with SABER-Placebo. The 5.0 mL dose of SABER-Bupivacaine reduced the mean area under the curve of pain intensity on movement compared with SABER-Placebo (2.47 versus 3.60; P = 0.0033) and decreased the number of patients requiring supplemental opioids by 26% (although not statistically significant; P = 0.0909). Normal wound healing was reported throughout the trial and at 3- and 6-month follow-up in every treatment group.Conclusion: After open inguinal hernia repair, SABER-Bupivacaine administered at the surgical site was safe and provided pain relief, reduced the need for supplemental (oral and parenteral) analgesia and did not impair wound healing.
机译:背景:疼痛缓解仍然是疝气手术的主要问题。 SABRE-布比卡因是一种可吸收基质中的布比卡因研究性缓释制剂,可提供长达72小时的局部疼痛缓解。方法:进行了一项双盲,随机对照试验,以评估SABER-布比卡因的安全性和有效性。在澳大利亚和新西兰的五个地点接受开放性腹股沟疝修补术的同意患者(n = 124)被随机分配接受2.5(330 mg)或5.0 mL(660 mg)的SABER-布比卡因或SABER-安慰剂施用于手术伤口在过程结束时。结果:SABER-布比卡因与SABER-安慰剂相比,安全性高,副作用发生率无差异。与SABER-安慰剂相比,5.0 mL剂量的SABER-布比卡因减少了运动时疼痛强度曲线下的平均面积(2.47对3.60; P = 0.0033),并且需要补充阿片类药物的患者人数减少了26%(尽管没有统计学意义)有效; P = 0.0909)。在整个试验过程中以及每个治疗组的3个月和6个月随访中均报告伤口愈合正常。结论:腹股沟疝修补术开放后,在手术部位使用SABER-布比卡因是安全的,可缓解疼痛,减少了需要用于补充(口服和肠胃外)镇痛,并且不影响伤口愈合。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号