Rosenthal D, Murphy F, Gottschalk R, Baxter M, Lycka B, Nevin K
Division of Dermatology, McMaster University, Faculty of Health Sciences, St. Joseph's Hospital, Hamilton, Ontario, Canada.
J Wound Care. 2001 Jan;10(1):503-5. doi: 10.12968/jowc.2001.10.1.26042.
This multicentre, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of using Emla (lignocaine/prilocaine) anaesthetic cream to achieve pain control during sharp debridement of chronic leg ulcers of arterial, venous or arteriovenous aetiology. A total of 101 patients (51 Emla, 50 placebo), aged 29-99 years, who had experienced pain associated with previous debridement were included. Patients with an amide anaesthetic allergy, anaesthetic diabetic ulcers, or ulcers > 50 cm2 were excluded. Debridement was initiated approximately 30 minutes after the application of a thick layer of Emla or placebo cream to an ulcer occluded with a plastic wrap. The patient and investigator assessed the pain associated with debridement on a 100 mm visual analogue scale (VAS). The median patient VAS scores were 18 mm and 53.5 mm in the Emla and placebo groups, respectively (p < 0.0001). The corresponding investigator values in the two groups were 20 mm and 49.5 mm, respectively (p = 0.004). Local reactions were mainly transient and mild, and were observed in roughly the same percentage of placebo and Emla-treated patients. After a 30-minute application Emla cream significantly reduced the pain of debridement compared with the placebo.
这项多中心、双盲、安慰剂对照、平行组研究评估了使用复方利多卡因乳膏(利多卡因/丙胺卡因)麻醉乳膏在对动脉、静脉或动静脉病因的慢性腿部溃疡进行锐性清创时实现疼痛控制的疗效和安全性。共有101例年龄在29至99岁之间、曾经历过与先前清创相关疼痛的患者入组(51例使用复方利多卡因乳膏,50例使用安慰剂)。排除有酰胺类麻醉剂过敏、麻醉性糖尿病溃疡或溃疡面积>50 cm²的患者。在向用保鲜膜覆盖的溃疡涂抹一层厚厚的复方利多卡因乳膏或安慰剂乳膏后约30分钟开始清创。患者和研究者使用100 mm视觉模拟量表(VAS)评估与清创相关的疼痛。复方利多卡因乳膏组和安慰剂组患者的VAS评分中位数分别为18 mm和53.5 mm(p<0.0001)。两组中相应的研究者评分分别为20 mm和49.5 mm(p = 0.004)。局部反应主要是短暂且轻微的,在安慰剂组和使用复方利多卡因乳膏治疗的患者中出现的比例大致相同。与安慰剂相比,涂抹30分钟的复方利多卡因乳膏显著减轻了清创时的疼痛。