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Levobupivacaine caudal anesthesia in children: a randomized double-blind comparison with bupivacaine.

机译:小儿左布比卡因尾巴麻醉:与布比卡因的随机双盲比较。

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BACKGROUND: Levobupivacaine is the pure S-enantiomer of bupivacaine. Despite obvious benefits in the event of accidental intravascular injection there has been no studies demonstrating a clinically significant benefit to levobupivacaine over racemic bupivacaine for pediatric regional anesthesia. Given the similar pharmacokinetic profiles of both drugs the studies to date have been underpowered to demonstrate what is likely to be a small difference in clinical effectiveness. Our aim was to determine if there are significant differences in the clinical effectiveness of levobupivacaine compared with racemic bupivacaine for caudal anesthesia in children having lower abdominal surgery. A secondary aim was to determine if there are differences in the incidence of postoperative motor blockade between these agents. METHODS: Three hundred and ten children ranging in age from 1 month to 10.75 years in age having lower abdominal surgery were enrolled. Patients were randomized in a double blind manner to receive acaudal block with either 0.25% bupivacaine (n = 152) or 0.25% levobupivacaine (n = 155) to a total volume of 1 ml x kg(-1). Motor blockade (modified Bromage scale) and postoperative pain or distress (FLACC behavioral scale for postoperative pain) were measured at predetermined time points during the subsequent 120 min. RESULTS: There were no significant adverse effects attributable to levobupivacaine. Success rates were defined as a lack of hemodynamic response to first surgical incision and low postoperative pain scores. At a mean duration of 5 min between block completion and first incision success for 1 ml x kg(-1) of 0.25% bupivacaine was 91% and 94% for 0.25% levobupivacaine. Satisfactory postoperative analgesia was present in 98% of patients after bupivacaine caudal anesthesia and 97.5% for levobupivacaine. At 30 min following caudal anesthesia the incidence of postoperative motor block with racemic bupivacaine was 84% and decreased to 7% at 120 min. For levobupivacaine motor block at 30 min postcaudal was present in 85% and decreased to 11% at 120 min. CONCLUSIONS: Levobupivacaine is an effective agent for caudal anesthesia in children at a recommended dose of 2.5 mg x kg(-1). The rapidity of onset was suitable for establishment of surgical anesthesia and postoperative analgesia was achieved in greater than 97.5% of patients. It appears to be of equivalent potency to racemic bupivacaine in children requiring lower abdominal surgery.
机译:背景:左布比卡因是布比卡因的纯S对映体。尽管在意外血管内注射的情况下有明显的益处,但尚无研究表明左旋布比卡因相对于消旋布比卡因在儿科区域麻醉中具有临床上的显着益处。考虑到两种药物的药代动力学特征相似,迄今为止,尚不足以证明临床有效性可能存在微小差异的研究。我们的目的是确定在下腹部手术的儿童中,左旋布比卡因与外消旋布比卡因在尾麻醉中的临床疗效是否存在显着差异。第二个目的是确定这些药物之间的术后运动阻滞发生率是否存在差异。方法:招募了一百三十名年龄在1个月至10.75岁的儿童进行了下腹部手术。患者以双盲方式随机接受0.25%布比卡因(n = 152)或0.25%左旋布比卡因(n = 155)的尾部阻滞,总体积为1 ml x kg(-1)。在随后的120分钟内的预定时间点,测量运动阻滞(改良的Bromage量表)和术后疼痛或困扰(术后疼痛的FLACC行为量表)。结果:左旋布比卡因无明显不良反应。成功率定义为对首次手术切口缺乏血流动力学反应且术后疼痛评分低。 1 ml x kg(-1)的0.25%布比卡因的阻滞形成与首次切开成功之间的平均持续时间为5分钟,左旋布比卡因的浓度分别为91%和94%。布比卡因尾巴麻醉后98%的患者术后满意镇痛,左旋布比卡因为97.5%。尾麻醉后30分钟,消旋布比卡因术后运动阻滞的发生率为84%,而在120分钟时降至7%。对于左旋布比卡因运动阻滞,在30分钟时尾部存在率为85%,在120分钟时降至11%。结论:左布比卡因是儿童尾巴麻醉的有效药物,建议剂量为2.5 mg x kg(-1)。起效快适合于手术麻醉的建立,并且在超过97.5%的患者中实现了术后镇痛。对于需要下腹部手术的儿童,它似乎与消旋布比卡因具有同等效力。

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