下肢手术患者罗哌卡因与布比卡因蛛网膜——下腔阻滞效果的比较前瞻性、多中心、随机、双盲研究

Comparison of efficacy of ropivacaine and bupivacaine for spinal anesthesia in patients undergoing unilateral lower limb surgery： a prospective, multicenter, randomized, double-blind study

目的比较单侧下肢手术患者罗哌卡因和布比卡因蛛网膜下腔阻滞的效果。方法本试验为前瞻性、多中心、随机、双盲的临床研究。拟行单侧下肢手术患者218例，ASAⅠ或Ⅱ级，年龄18—64岁，体重指数18—24kg/m^2，性别不限。随机分为2组，R组（n=110）蛛网膜下腔注射5mg/ml罗哌卡因3．5ml；B组（n=108）蛛网膜下腔注射5mg／ml布比卡因2．5ml。采用改良的Bromage评分法评估非术侧下肢的运动阻滞效果，记录起效时间和维持时间；采用针刺法评估感觉阻滞效果，记录起效时间和维持时间；评估术中麻醉质量与肌松效果；记录不良反应的发生情况。结果与B组比较，R组运动阻滞起效时间延长，运动阻滞和感觉阻滞维持时间缩短（P〈0．05或0．01），感觉阻滞起效时间差异无统计学意义（P〉0．05）；两组运动阻滞和感觉阻滞有效率差异无统计学意义（P〉0．05）；两组麻醉质量和肌松效果均较好，麻醉质量比较差异无统计学意义（P〉0．05），R组肌松效果优于B组（P〈0．05）；两组不良事件发生率均较低，且差异无统计学意义（P〉0．05）。结论下肢手术患者采用罗哌卡因蛛网膜下腔阻滞时，术中麻醉质量及肌松效果良好，且其运动阻滞维持时间较布比卡因短，有利于术后的恢复，其临床效果更具优越性。

Objective To compare the efficacy of ropivacaine and bupivacaine for spinal anesthesia in patients undergoing unilateral lower limb surgery. Methods This was a prospective, multicenter, randomized, double-blind clinical trial. Two hundred and eighteen patients of both sexes, ASA Ⅰ or Ⅱ ,aged 18-64 yr, with body mass index 18-24 kg/m^2 , scheduled for unilateral lower limb surgery, were randomly divided into 2 groups： group R （ n = 110） received intrathecally 3.5 ml of ropivacaine 5 mg/ml and group B （ n = 108） received intrathecally 2.5 ml of bupivacaine 5 mg/ml. The degree of motor block for the nonoperative lower limb was assessed by modified Bromage scale, and the onset time and duration were recorded. The degree of sensory block was assessed with pin prick test, and the onset time and duration were recorded. The quality of anesthesia and degree of muscle relaxation during ＇operation were assessed and the adverse effects were also recorded. Results The onset time of motor block was significantly longer and the duration of motor and sensory block was significantly shorter in group R than in group B （ P 〈 0.05 or 0.01）, and there was no significant difference in the onset time of sensory block （ P 〉 0.05） . There was no significant difference in the effective rate of motor and sensory block between both groups （ P 〉 0.05 ）. The quality of anesthesia and degree of muscle relaxation were good in both groups and there was no significant difference in the quality of anesthesia between both groups （P 〉 0.05 ）, and the degree of muscle relaxation was significandy better in group R than in group B （ P 〈 0.05）. The incidence of adverse effects was lower in both groups without significant difference between them（ P 〉 0.05）. Conclusion The quality of anesthesia and degree of muscle relaxation are good during operation in patients undergoing unilateral lower limb surgery when the spinal anesthesia is performed with ropivacaine. The duration of motor block of ropivacaine is shorter than that of bupivacaine, which is beneficial to post-operative recovery, so the clinical efficacy has more superiority.