Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. EMLA cream as a topical anesthetic for the repeated mechanical debridement of venous leg ulcers: a double-blind, placebo-controlled study. Repeated treatment with lidocaine/prilocaine cream (EMLA) as a topical anaesthetic for the cleansing of venous leg ulcers. A controlled study. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Randomised, comparative study of three primary dressings for the treatment of venous ulcers.
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. A granulating surface is important for skin grafting and healing of leg ulcers. Mechanical debridement to remove necrotic tissue often must be stopped before completion because of pain.
                Our purpose was to assess the effect of EMLA cream on the number of debridements required to obtain a clean ulcer and on pain during debridement and to determine its safety after repeated doses.
                In this randomized double-blind, placebo-controlled study, 69 patients with venous leg ulcers received cream before debridement until a clean ulcer was obtained (or a maximum of 15 debridements).
                EMLA decreased the median number of debridements required for a clean ulcer (EMLA 11.5, placebo >15; P = .019) and decreased pain by 50% (P = .003). Plasma levels of lidocaine, prilocaine, and their main metabolites were low without any apparent accumulation.
                EMLA produces effective pain relief for the debridement of leg ulcers and shortens the time to a clean ulcer. Repeated topical analgesia with EMLA 5% cream prior to the cleansing of venous leg ulcers was studied. Patients were randomly allocated to a series of 8 treatments with EMLA (n = 22) or to a control group (n = 21). A thick layer of the cream was applied to the ulcers for 30 min. At each of the 8 treatments, local reactions were assessed on a 4-point scale and pain from ulcer cleansing on a visual analogue scale. At the first and the last treatment the area of the ulcer was determined by mapping, a sample for a bacterial culture was taken and the amount of dead tissue, slough and granulation tissue present was assessed. Treatment with EMLA for 30 min significantly decreased the pain from cleansing of the leg ulcers and the frequency of post-cleansing pain. The analgesic effect remained unchanged with successive treatments. Repeated treatment with EMLA in leg ulcers would appear to be safe, as indicated by the absence of any serious untoward events. No statistically significant differences in local reactions or adverse effects on granulation tissue, ulcer area or bacterial flora were observed in the EMLA-treated patients compared with the control patients. The analgesic effect of EMLA 5% cream for surgical cleansing of leg ulcers was investigated in an open study and in a double-blind comparison with placebo. Eighty patients with ulcers of venous or arterial origin participated. The cream was applied under occlusion and removed before cleansing. Plasma concentrations of lidocaine and prilocaine were assessed. The maximum individual concentrations were 0.8 microgram/ml for lidocaine and 0.08 microgram/ml for prilocaine. Pain was assessed according to a verbal rating scale and on a 100 mm visual analogue scale. The median VAS pain scores for EMLA and placebo were 18.5 and 84 mm (p less than 0.01). There were no severe adverse reactions. The results show that there is a need for pain control in surgical debridement of leg ulcers and that EMLA cream gives satisfactory analgesia for this procedure. In this article, we describe a randomised trial in which two established primary dressings - Comfeel (Coloplast, UK) and Granuflex improved formulation (Convatec, UK) - were compared to Cutinova foam (Beiersdorf Medical, UK) in the management of venous leg ulcers. Patients that met the study trial criteria were randomised to receive one of the three primary dressings. All ulcers were secondarily bandaged with Comprilan (Beiersdorf Medical, UK) short-stretch compression. The three dressings were compared in terms of their ability to promote ulcer healing (closure rate and healing rate) and reduce the prevalence and severity of ulcer-associated pain, over a 12-week period. The ease with which dressings could be used in a busy outpatient clinic setting was also considered. On enrollment, groups were well matched in terms of all of the patient and ulcer parameters studies. Six patients were withdrawn for reasons unrelated to study dressings or trial procedures. Following non-parametric analysis of the study data, the three dressings were found to be equally effective at promoting ulcer healing and alleviating ulcer-associated pain. Study personnel rated Cutinova Foam as easy, if not easier, to use than Comfeel or Granuflex. This study suggests that Cutinova Foam is as safe and effective as both Comfeel and Granuflex, in the treatment of venous leg ulcers.
There is some evidence to suggest that ibuprofen dressings may offer pain relief to people with painful venous leg ulcers. EMLA (5%) appears to provide effective pain relief during the debridement of venous leg ulcers. Further research should consider standardised pain assessment methods and assess both the effect on ulcer healing and the impact of long term use of these treatments.