Chalam K V, Murthy Ravi K, Agarwal Swati, Gupta Shailesh K, Grover Sandeep
Department of Ophthalmology, University of Florida College of Medicine, Jacksonville, Florida, USA.
BMC Ophthalmol. 2009 Aug 17;9:7. doi: 10.1186/1471-2415-9-7.
To compare the clinical efficacy of lidocaine 2% with tetracaine 0.5% for cataract surgery.
In a randomized, multi-surgeon, controlled clinical trial,122 consecutive cataract cases eligible for topical anesthesia, were randomly assigned to receive lidocaine 2% gel (1 ml) or tetracaine solution 0.5% (TetraVisc, 0.5 ml) before clear corneal phacoemulsification. Main outcome measure was visual analog scale (0 to 10), which was used to measure intra-operative pain. Secondary outcome measures included patients' discomfort due to tissue manipulation and surgeon graded patients' cooperation. Duration of surgery and intra-operative complications were also recorded.
The mean age in TetraVisc (TV) group was 70.4 years and in the lidocaine gel group (LG) it was 70.6 years (p = 0.89). Patient reported mean intra-operative pain scores by visual analog scale were 0.70 +/- 0.31 in TV group and 1.8 +/- 0.4 in LG group (P < 0.001). Mean patient cooperation was also marginally better in the TV group (8.3 +/- 0.3) compared to LG group (8.4 +/- 0.6) (P = 0.25). 96% of patients in TV group showed intra-operative corneal clarity compared to 91% in LG group. TV group had less (1 out of 61 patients, 1.6%) intra-operative complications than LG group (3 out of 61 patients, 4.8%). No anesthesia related complications were noted in either group
Topical TetraVisc solution was superior to lidocaine 2% gel for pain control in patients undergoing clear corneal phacoemulsification. Lidocaine 2% gel is similar to TetraVisc in patient comfort and surgeon satisfaction.
Clinical trials number: ISRCTN78374774.
比较2%利多卡因与0.5%丁卡因用于白内障手术的临床疗效。
在一项随机、多术者、对照临床试验中,122例符合表面麻醉条件的连续白内障病例,在透明角膜超声乳化术前被随机分配接受2%利多卡因凝胶(1毫升)或0.5%丁卡因溶液(TetraVisc,0.5毫升)。主要观察指标是视觉模拟评分(0至10分),用于测量术中疼痛。次要观察指标包括患者因组织操作引起的不适以及术者对患者合作程度的分级。还记录了手术时间和术中并发症。
TetraVisc(TV)组的平均年龄为70.4岁,利多卡因凝胶组(LG)为70.6岁(p = 0.89)。患者通过视觉模拟评分报告的术中平均疼痛评分,TV组为0.70±0.31,LG组为1.8±0.4(P < 0.001)。TV组患者的平均合作程度也略优于LG组(8.3±0.3),LG组为(8.4±0.6)(P = 0.25)。TV组96%的患者术中角膜保持清晰,而LG组为91%。TV组的术中并发症(61例患者中的1例,1.6%)少于LG组(61例患者中的3例,4.8%)。两组均未观察到与麻醉相关的并发症。
在接受透明角膜超声乳化术的患者中,表面应用TetraVisc溶液在疼痛控制方面优于2%利多卡因凝胶。2%利多卡因凝胶在患者舒适度和术者满意度方面与TetraVisc相似。
临床试验编号:ISRCTN78374774。