Martínez-Bourio R, Arzuaga M, Quintana J M, Aguilera L, Aguirre J, Sáez-Eguilaz J L, Arízaga A
Service of Anesthesiology and Surgical Intensive Care Unit, Hospital de Galdakao, Bizkaia, Spain.
Anesthesiology. 1998 Mar;88(3):624-8. doi: 10.1097/00000542-199803000-00011.
Hyperbaric 5% lidocaine has been associated with transient neurologic symptoms (TNSs) after spinal anesthesia. A prospective, masked, randomized study was conducted to compare the incidence of TNSs after spinal anesthesia with hyperbaric 5% lidocaine or 5% prilocaine to assess the utility of prilocaine as an alternative to lidocaine in patients having short surgical procedures.
The number of patients to be enrolled (100 per group) was determined by power analysis (80%, P = 0.05) considering an incidence of TNSs after spinal anesthesia with lidocaine of at least 11% according to data reported in other studies. Two hundred patients scheduled for elective surgery expected to last <60 min were allocated at random to receive spinal anesthesia with hyperbaric 5% lidocaine or hyperbaric 5% prilocaine. Three to 5 days after spinal anesthesia, all patients were interviewed by an anesthesiologist who was blinded to the group assignment and details of the anesthetic and surgical technique using a standardized symptom checklist. Patients with symptoms underwent neurologic examination.
Both groups were comparable with regard to demographic data and details of the surgical and anesthetic procedures. The incidence of TNSs in both groups was low and differences were not found (4% in the lidocaine group and 1% in the prilocaine group). The mean age of patients with TNSs (58 yr) was higher than that of patients without TNSs (48 yr; P < 0.05). No relation with any of the other variables was found.
The low incidence of TNSs among lidocaine-anesthetized patients (4%) may account for the lack of significant differences between hyperbaric 5% lidocaine and 5% prilocaine and to the insufficient power of the study to exclude the possibility of a type II error.
高压5%利多卡因与脊髓麻醉后短暂性神经症状（TNSs）相关。进行了一项前瞻性、双盲、随机研究，比较高压5%利多卡因或5%丙胺卡因脊髓麻醉后TNSs的发生率，以评估丙胺卡因作为利多卡因替代品在短手术患者中的效用。
根据其他研究报告的数据，考虑利多卡因脊髓麻醉后TNSs发生率至少为11%，通过功效分析（80%，P = 0.05）确定每组纳入患者数量（每组100例）。将200例计划进行预期持续时间<60分钟的择期手术患者随机分配，接受高压5%利多卡因或高压5%丙胺卡因脊髓麻醉。脊髓麻醉后3至5天，由一名对分组情况以及麻醉和手术技术细节不知情的麻醉医生使用标准化症状清单对所有患者进行访谈。有症状的患者接受神经学检查。
两组在人口统计学数据以及手术和麻醉程序细节方面具有可比性。两组TNSs发生率均较低，未发现差异（利多卡因组为4%，丙胺卡因组为1%）。发生TNSs的患者平均年龄（58岁）高于未发生TNSs的患者（48岁；P < 0.05）。未发现与任何其他变量有关。
利多卡因麻醉患者中TNSs的低发生率（4%）可能解释了高压5%利多卡因和5%丙胺卡因之间缺乏显著差异以及该研究排除II型错误可能性的功效不足。
