psd-502 and Leg-Ulcer

Venous leg ulcers affect up to 1% of people at some time in their lives and are often painful. The main treatments are compression bandages and dressings. Topical treatments to reduce pain during and between dressing changes are sometimes used.. To determine the effects of topical agents or dressings for pain in venous leg ulcers.. For this third update the following databases were searched: Cochrane Wounds Group Specialised Register (searched 9 May 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 4); Ovid MEDLINE (2009 to April Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations May 08, 2012); Ovid EMBASE (2009 to 2012 Week 18); and EBSCO CINAHL (2009 to May 2 2012). No date or language restrictions were applied.. Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of topical agents or dressing for the treatment of pain in venous ulcers were included.. Two review authors independently performed trial selection, data extraction and risk of bias assessment.. Six trials (343 participants) evaluated Eutectic Mixture of Local Anaesthetics (EMLA): lidocaine-prilocaine cream for the pain associated with ulcer debridement. The between-group difference in pain measured on a 100 mm scale was statistically significant in favour of EMLA (MD -20.65, 95% CI -12.19 to -29.11). No significant between-group differences in burning or itching were observed.Two trials (470 participants with venous leg ulcers) evaluated ibuprofen slow-release foam dressings for persistent venous leg ulcer pain. Compared with local best practice, significantly more participants in the ibuprofen dressing group achieved the outcome of >50% of the total maximum pain relief score between day 1 and day 5 than participants in the local best practice group (RR 1.63, 95% CI 1.24 to 2.15). The number needed to treat was 6 (95% CI 4 to 12). In the second trial, compared with an identical non-ibuprofen foam dressing, there was no statistically significant difference in the proportion of participants experiencing slight to complete pain relief on the first evening of treatment.Limited data were available to assess healing rates or adverse events.. 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.

Topics: Administration, Topical; Analgesics; Anesthetics, Local; Bandages; Debridement; Humans; Ibuprofen; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Ointments; Pain; Prilocaine; Randomized Controlled Trials as Topic; Varicose Ulcer

Venous leg ulcers affect up to 1 per cent of people at some time in their life. These ulcers are often painful and some clinicians choose dressings and topical treatments (analgesia/ local anaesthetic) to reduce the pain both during and between dressing changes.. To assess the effectiveness of dressings, local anaesthetics or topical analgesia for pain relief in venous leg ulceration.. Cochrane Wounds Group Register and the Cochrane Collaboration Field in Complementary Medicine were searched in June 2002. Cochrane Pain Palliative and Supportive Care Group and Cochrane Wounds Group strategy were combined and used.. All randomised controlled trials which evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement.. Eligibility for inclusion was confirmed by two reviewers who independently assessed the potential trials. Details of eligible studies were summarised using a data extraction sheet which was checked by the second reviewer.. No trials evaluating interventions for persistent pain were identified for the initial review in 1999 nor the update in 2002. Three trials were included in the 1999 review comparing a eutectic mixture of local anaesthetic (EMLA) versus placebo for pain at debridement. In 2002 a further 3 trials were available (6 trials in total with 317 patients). The studies were considered sufficiently similar to pool and meta analysis found a statistically significant reduction in debridement pain scores with EMLA 5% cream. EMLA was associated with a reduction in pain scores (measured on a 100 mm scale) of 20.6 mm (95% Confidence Interval 29.11-12.19). One small trial measured healing as an outcome and found no difference in numbers of ulcers healed at the end of the study.. EMLA provides effective pain relief for venous leg ulcer debridement however, the effect of the product on ulcer healing is unknown. Research is required to determine the impact of debridement and of EMLA on ulcer healing. There were no trials addressing the treatment of persistent pain (between and at dressing changes) and further research is warranted.

Topics: Administration, Topical; Anesthetics, Local; Bandages; Debridement; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Ointments; Pain; Prilocaine

Venous leg ulcers affect up to 1 per cent of people at some time in their life. These ulcers are often painful and some clinicians choose dressings to reduce the pain both during and between dressing changes.. To assess the effectiveness of dressings, local anaesthetics/analgesics for pain relief in venous leg ulceration.. Cochrane Wounds Group Register and the Cochrane Collaboration Field in Complementary Medicine were searched. Cochrane Pain Palliative and Supportive Care Group and Cochrane Wounds Group strategy were combined and used.. All randomised controlled trials which evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement.. Eligibility for inclusion was confirmed by two reviewers who independently assessed the all potential trials. Details of eligible studies were summarised using a data extraction sheet which was checked by the second reviewer.. No trial evaluated interventions for persistent pain. Three trials compared a eutectic mixture of local anaesthetic (EMLA) versus placebo for pain at debridement. All 3 trials reported a significant difference in pain in favour of EMLA, however, one of the trials favoured placebo in terms of number of ulcers healed at the end of the trial and another trial noted an increased incidence of burning and itching with the use of EMLA.. EMLA may provide pain relief for venous leg ulcer debridement however, the effect of the product on ulcer healing and the incidence of itching and burning is unclear. Research is required to address questions such as the benefits of leg ulcer debridement and the impact of EMLA on healing and the incidence of burning and itching. There were no trials addressing the treatment of persistent pain and further research is warranted.

Topics: Administration, Topical; Anesthetics, Local; Bandages; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Ointments; Pain; Prilocaine

This study aimed to evaluate the effect of EMLA 5% cream applied to painful chronic leg ulcers (CLUs) as a primary dressing on wound healing and health-related quality of life (HRQoL). A pilot, parallel-group, nonblinded, randomized controlled trial was conducted in 6 community nursing procedure clinics in New South Wales, Australia. A total of 60 participants with painful CLUs of varied etiology were randomly assigned to the intervention (EMLA daily for 4 weeks as a primary dressing, followed by usual care) or usual care only. Wound size and HRQoL were measured at baseline, end of the intervention period (week 4), and week 12. At baseline, wound sizes were similar for both the intervention and control groups. During the intervention period, there was no significant difference in wound sizes between groups (intervention group: median (cm

Topics: Aged; Aged, 80 and over; Australia; Chronic Disease; Cross-Over Studies; Female; Follow-Up Studies; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Occlusive Dressings; Pain Measurement; Pilot Projects; Prilocaine; Quality of Life; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome; Wound Healing

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.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Anesthetics, Local; Chronic Disease; Debridement; Double-Blind Method; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Ointments; Pain; Pain Measurement; Prilocaine; Time Factors; Treatment Outcome

Although the lignocaine (lidocaine)-prilocaine cream EMLA has been extensively studied for the relief of acute treatment-related pain from sharp leg ulcer debridement, no data exist on systemic absorption from prolonged application in patients with chronically painful ulcers.. To study the plasma concentrations of lignocaine and prilocaine resulting from prolonged application of EMLA to leg ulcers.. A single 24-h application of 5-10 g (median 6.75) of EMLA was given to 10 patients with painful leg ulcers measuring 50-100 cm2. Venous blood samples, drawn between 0.5 and 27 h after cream application, were analysed by gas chromatography using a nitrogen-sensitive detector.. The peak plasma levels were in the range 185-705 ng mL(-1) and 62-277 ng mL(-1) for lignocaine and prilocaine, respectively, and were observed 2-4 h (in one patient 6-8 h) after application. The peak plasma concentration of lignocaine, but not of prilocaine, increased significantly with increasing dose. The cream was well tolerated by the patients.. The results indicate that a 24-h application of 5-10 g EMLA results in peak plasma concentrations of the two local anaesthetics, which combined are less than one-fifth of those associated with toxic reactions. The analgesic efficacy of EMLA for the relief of chronic ulcer pain deserves further study.

Topics: Aged; Aged, 80 and over; Anesthetics, Combined; Anesthetics, Local; Chronic Disease; Dose-Response Relationship, Drug; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Ointments; Prilocaine; Regression Analysis

Pain prevents the effective cleansing of many leg ulcers. Pain relief during debridement has been reported after topical anaesthesia with EMLA cream. The purpose of this study was to assess and compare the pain intensity during debridement after different lengths of application time of EMLA. Fifty-nine patients, stratified for leg ulcer type, were randomised to 10, 20 or 60 minutes treatment with EMLA prior to debridement. The pain was rated by each patient on a 100-mm visual analogue scale (VAS). Pain intensity during debridement decreased significantly with increasing duration of EMLA application (p = 0.001). The median values of the VAS pain scores were 41, 20 and 8 in the 10-, 20- and 60- minute groups respectively. A minimum of 20 minutes application time gives substantial pain relief in the majority of patients.

Topics: Administration, Topical; Aged; Aged, 80 and over; Anesthetics, Combined; Debridement; Drug Administration Schedule; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Pain; Pain Measurement; Prilocaine; Time Factors; Treatment Outcome

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.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anesthetics, Local; Debridement; Double-Blind Method; Drug Combinations; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Pain; Pain Measurement; Prilocaine; Random Allocation

Plasma concentrations of lidocaine and prilocaine were assessed in 8 patients after the application of 8-10 g EMLA 2% cream for 60 min to leg ulcers measuring 31-80 cm2. Maximum individual plasma concentrations were 205 ng/ml for lidocaine and 79 ng/ml for prilocaine, which is twenty times lower than those associated with toxicity. The analgesic effect of EMLA 2% and 5% cream for the surgical cleansing of leg ulcers was compared in a double-blind, four-period, cross-over study in 10 patients. The ulcer was covered with a thick layer of cream for 30 min before four consecutive debridements 1-4 days apart. While the 2% and 5% creams had similar analgesic effects post-cleansing pain tended to be more frequent with the 2% cream.

Topics: Aged; Aged, 80 and over; Anesthetics, Local; Double-Blind Method; Drug Combinations; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Ointments; Pain Measurement; Prilocaine; Random Allocation

Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Combined; Anesthetics, Local; Chronic Pain; Drug Administration Schedule; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Prilocaine; Treatment Outcome

Topics: Debridement; Drug Hypersensitivity; Drug Interactions; Female; Fever; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Middle Aged; Pain, Postoperative; Prilocaine; Skin

While treating a 63-year-old woman with leg ulcerations, we observed an unusual phenomenon. A wound débridement was planned to remove adherent necrotic material. After topical anesthesia with a lidocaine-prilocaine mixture (EMLA cream) a hemorrhagic,livid margin area developed around the ulcer 90 minutes after application. The area turned necrotic over days and the center was débrided. A more detailed history revealed that similar necrosis had occurred previously when EMLA cream had been employed. We interpreted the current event,as well as the past episodes,as a pathological reaction of the small cutaneous blood vessels to EMLA cream. The history also revealed an overlap connective tissue disease with microvascular impairment. After exposure to the topical anesthetics, the pre-damaged cutaneous blood vessels presumably produced a critical ischemia with subsequent necrosis. Based on this case, we recommend careful use of EMLA cream with frequent monitoring for necrosis when treating patients with a known disorder of microcirculation.

Topics: Anesthetics, Local; Debridement; Diagnosis, Differential; Disease Progression; Drug Eruptions; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Middle Aged; Necrosis; Patch Tests; Prilocaine

Sharp debridement is the most efficient method for clearing the woundbed in the exudation and granulation phase of wound healing. At our clinic the anaesthetic lidocaine-prilocaine cream, EMLA, has been used as an analgesic for sharp debridement since 1994. A review of patients' records was conducted, including ulcer size, dose of cream used, analgesic efficacy and complications. During a 6-year period a total of 1084 patients were treated for leg ulcers, decubitus ulcers, abscess revisions, anal and coccyx fistulae, postoperative wounds, diabetic ulcers and burns. Doses ranging from 3 to 150 g cream were applied for 45-60 min. In all patients except three the analgesia was adequate for debridement. We observed no allergic reactions, no clinical symptoms of local anaesthetic toxicity or methaemoglobinaemia. In 12 patients (1.1%) a burning sensation was reported directly after the application of EMLA cream to the ulcer, which, however, subsided within 15-20 min. In our experience, sharp debridement in percutaneous analgesia with EMLA is efficient, economical, safe, and tolerable for the patient.

Topics: Anesthetics, Combined; Debridement; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Ointments; Prilocaine; Wound Healing

Topics: Age Distribution; Aged; Anesthetics, Local; Bandages; Debridement; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Pain; Prevalence; Prilocaine; Skin Care; Wound Healing

Topics: Aged; Aged, 80 and over; Anesthetics, Local; Debridement; Epilepsy, Tonic-Clonic; Female; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Ointments; Prilocaine

Topics: Anesthetics, Combined; Anesthetics, Local; Debridement; Humans; Leg Ulcer; Lidocaine; Lidocaine, Prilocaine Drug Combination; Occlusive Dressings; Pain; Prilocaine; Research Design; Treatment Outcome