0.75%左旋布比卡因与0.75%布比卡因用于球周麻醉的疗效与安全性比较

The efficacy and safety of 0.75% levobupivacaine vs 0.75% bupivacaine for peribulbar anaesthesia.

作者信息

Birt D J, Cummings G C

机构信息

Department of Anaesthesia, Derriforf Hospital, Plymouth, UK.

出版信息

Eye (Lond). 2003 Mar;17(2):200-6. doi: 10.1038/sj.eye.6700313.

DOI:10.1038/sj.eye.6700313

PMID:12640407

Abstract

BACKGROUND

Levobupivacaine, the S(-)-enantiomer of racemic bupivacaine, is associated with a similar efficacy but a reduced potential for cardiovascular and central nervous system toxicity than racemic bupivacaine. Thus, this prospective, randomised, double-masked study was undertaken to assess the efficacy and safety of 0.75% levobupivacaine vs 0.75% bupivacaine, each with hyaluronidase, for peribulbar anaesthesia.

METHODS

A total of 60 patients undergoing elective anterior segment surgery were randomly allocated to receive either agent by a single, inferotemporal peribulbar injection technique, supplemented with a medial canthus injection if necessary. Ocular akinesia and orbicularis oculi function were assessed by scoring systems at 2 min intervals until satisfactory akinesia was achieved, and movements were reassessed on the day after surgery to confirm regression of the block.

RESULTS

The time taken to reach a state of satisfactory anaesthesia and akinesia was deemed to be the primary measure of efficacy. Both agents achieved this in a similar median time of 2 min after receiving 5 ml of the injectate, and the treatment difference was not statistically significant (P=0.24). Blood samples from the first 20 patients were taken at intervals up to 4 h. These were analysed for plasma levels and confirmed similar plasma concentration vs time profiles for the two agents. Seven patients in each group (23%) complained of pain on injection but the technique was generally well tolerated. Two patients in the levobupivacaine group experienced serious adverse events, but neither was considered related to the study medication. The most common minor post-operative adverse event was prolongation of the local anaesthetic block, which was reported by nine patients (four in the levobupivacaine group and five in the bupivacaine group).

CONCLUSIONS

Levobupivacaine and bupivacaine are equally successful in achieving clinically satisfactory peribulbar anaesthesia with few adverse effects.

摘要

背景

左旋布比卡因是消旋布比卡因的S(-)-对映体，其疗效与消旋布比卡因相似，但与心血管和中枢神经系统毒性相关的可能性低于消旋布比卡因。因此，开展了这项前瞻性、随机、双盲研究，以评估0.75%左旋布比卡因与0.75%布比卡因分别联合透明质酸酶用于球周麻醉的疗效和安全性。

方法

总共60例行择期眼前节手术的患者通过颞下象限单一针眼球周注射技术随机分配接受其中一种药物治疗，必要时在内眦补充注射。每隔2分钟通过评分系统评估眼肌运动不能和眼轮匝肌功能，直至达到满意的运动不能，术后次日重新评估眼球运动以确认阻滞消退。

结果

达到满意麻醉和运动不能状态所需时间被视为疗效的主要衡量指标。两种药物在接受5毫升注射液后达到此状态的中位时间相似，均为2分钟，治疗差异无统计学意义（P=0.24）。对前20例患者每隔一定时间采集血样直至4小时。对这些血样进行血浆水平分析，确认两种药物的血浆浓度-时间曲线相似。每组有7例患者（23%）抱怨注射时疼痛，但该技术总体耐受性良好。左旋布比卡因组有2例患者发生严重不良事件，但均被认为与研究用药无关。最常见的术后轻微不良事件是局部麻醉阻滞时间延长，有9例患者报告（左旋布比卡因组4例，布比卡因组5例）。