A multicentre, double blind placebo-controlled study of a lidocaine/prilocaine cream (emla 5%) used as a topical anaesthetic for surgical debridement of venous leg ulcers

Objective: The aim of this double-masked, placebo-controlled trial was to confirm the anaesthetic effect of EMLA cream compared with placebo when used for sharp debridement of venous leg ulcers and to test its feasibility with respect to the usual procedure. Methods: One hundred and ten patients with venous ulcers were randomised to EMLA or placebo cream treatment for 30-45 min. Pain from debridement was evaluated by the patient on a 100 mm visual analogue scale (VAS) and by the physician on a verbal scale. Results: The median VAS scores were 16.5 and 52 in EMLA- and placebo-treated patients, respectively (p<0.00001), a clinically relevant difference. On the vertebral scale 61% of EMLA patients and 21% of placebo patients were placed in the category of no pain (p<0.0001). The physicians found debridement with EMLA easier to perform (p<0.01). Conclusion: Debridement of venous leg ulcers using topical anaesthesia is easy and safe, with adequate pain relief in both in- and outpatients.