Efficacy and safety of 5% lidocaine-medicated plasters in localized pain with neuropathic and/or inflammatory characteristics: an observational, real-world study.

OBJECTIVE: Based on clinical study results, 5% lidocaine-medicated plaster (5% LMP) is currently recommended for the treatment of localized peripheral neuropathic pain, such as post-herpetic neuralgia (PHN). However, its effective action, as well as the high safety, have indeed led to its use in clinical practice for pain conditions with similar pathophysiological mechanisms. In this study, the efficacy and safety of 5% LMP were investigated in patients with localized pain with neuropathic and/or inflammatory characteristics, such as PHN, post-traumatic/surgical or musculoskeletal pain. PATIENTS AND METHODS: 503 patients with localized pain treated with 5% LMP were evaluated at baseline (T0), after 30 days (T30) and after 60 days (T60). The primary endpoint was number and proportion of 30% responders at T60, whereas secondary endpoints included number and proportion of 30% responders at T30, mean pain intensity, mean extension of the painful area, dynamic mechanical allodynia and quality of sleep. Evaluations were assessed in all patients and subgroups based on different clinical entities. Concomitant treatments and adverse reactions were also recorded. RESULTS: 72% and 90% of all patients responded to 5% LMP treatment at T30 and T60, respectively. Comparable results were also obtained in subgroups such as PHN patients (72% and 68% at T30 and T60, respectively), and musculoskeletal pain (73% and 83% at T30 and T60, respectively). The mean pain intensity, as well as the extension of the painful area, significantly decreased during the study, in all patients and each subgroup. In addition, secondary endpoints significantly improved at each time-point compared with baseline, in all groups. CONCLUSIONS: The effectiveness and safety of 5% LMP were shown in localized pain conditions such as neuropathic and, importantly, in musculoskeletal pain, a condition never investigated with this product. This field-practice study suggests that topical pain-reducing strategies such as 5% LMP could be effective in neuropathic and/or inflammatory, localized pain conditions.

What to Do, and What Not to Do, When Diagnosing and Treating Breakthrough Cancer Pain (BTcP): Expert Opinion.

Clinical management of breakthrough cancer pain (BTcP) is still not satisfactory despite the availability of effective pharmacological agents. This is in part linked to the lack of clarity regarding certain essential aspects of BTcP, including terminology, definition, epidemiology and assessment. Other barriers to effective management include a widespread prejudice among doctors and patients concerning the use of opioids, and inadequate assessment of pain severity, resulting in the prescription of ineffective drugs or doses. This review presents an overview of the appropriate and inappropriate actions to take in the diagnosis and treatment of BTcP, as determined by a panel of experts in the field. The ultimate aim is to provide a practical contribution to the unresolved issues in the management of BTcP. Five 'things to do' and five 'things not to do' in the diagnosis and treatment of BTcP are proposed, and evidence supporting said recommendations are described. It is the duty of all healthcare workers involved in managing cancer patients to be mindful of the possibility of BTcP occurrence and not to underestimate its severity. It is vital that all the necessary steps are carried out to establish an accurate and timely diagnosis, principally by establishing effective communication with the patient, the main information source. It is crucial that BTcP is treated with an effective pharmacological regimen and drug(s), dose and administration route prescribed are designed to suit the particular type of pain and importantly the individual needs of the patient.

Implementation of epidural analgesia for labor: is the standard of effective analgesia reachable in all women? An audit of two years.

BACKGROUND: Social and cultural factors combined with little information may prevent the diffusion of epidural analgesia for pain relief during childbirth. The present study was launched contemporarily to the implementation of analgesia for labor in our Department in order to perform a 2 years audit on its use. The goal is to evaluate the epidural acceptance and penetration into hospital practice by women and care givers and safety and efficacy during childbirth. PATIENTS AND METHODS: This audit cycle measured epidural analgesia performance against 4 standards: (1) Implementation of epidural analgesia for labor to all patients; (2) Acceptance and good satisfaction level reported by patients and caregivers. (3) Effectiveness of labor analgesia; (4) No maternal or fetal side effects. RESULTS: During the audit period epidural analgesia increased from 15.5% of all labors in the first trimester of the study to 51% in the last trimester (p < 0.005). Satisfaction levels reported by patients and care givers were good. A hierarchical clustering analysis identified two clusters based on VAS (Visual Analogue Scale) time course: in 226 patients (cluster 1) VAS decreased from 8.5±1.4 before to 4.1±1.3 after epidural analgesia; in 1002 patients (cluster 2) VAS decreased from 8.12±1.7 before (NS vs cluster 1), to 0.76±0.79 after (p < 0.001 vs before and vs cluster 2 after). No other differences between clusters were observed. CONCLUSIONS: Present audit shows that the process of implementation of labor analgesia was quick, successful and safe, notwithstanding the identification of one cluster of women with suboptimal response to epidural analgesia that need to be further studies, overall pregnant womens'adhesion to labor analgesia was satisfactory.

Micro opioid receptor A118G polymorphism and post-operative pain: opioids' effects on heterozygous patients.

The single-nucleotide-polymorphism (SNP) 118A>G in the micro-1 opioid receptor gene (OPRM1) is associated with a decrease in the analgesic effects of opioids. The aim of this study is to assess whether 118A >G polymorphism could influence the analgesic response to opioid-based postoperative pain (POP) therapy. The study consisted of two parts: section alpha, observational, included 199 subjects undergoing scheduled surgical procedures with pain management standardized on surgery invasiveness and on expected level of postoperative pain; section beta, randomized, included 41 women undergoing scheduled caesarean delivery with continuous intra-operative epidural anesthesia and post-operative analgesia (CEA). In both sections, POP was measured over 48 h (T6h-T24h-T48h) by the visual analogue scale (VAS). In section beta we also tested the responsiveness of hypothalamic-pituitary-adrenal axis (HPA) expressed by cortisol levels. In section alpha, with cluster analysis, subjects were analyzed according to their genotype: a group (no. 1) of 34 patients reporting VAS score >3 at every time lapse was identified and included only A118G carriers, while wild-type (A118A - absence of 118A>G polymorphism) patients were unevenly distributed between those with cluster no. 2 (VAS score <3 at every study steps) and those with cluster no. 3 (VAS score progressively reducing from T6h). In section beta, A118G carriers receiving epidural sufentanil had the lowest VAS scores at T24h; also in these patients, cortisol levels remained more stable, with a mild decrease at T6h. This study shows that the OPRM1 118A>G polymorphism affects postoperative pain response in heterozygous patients: they have a different postoperative pain response than patients with wild-type genes, which may affect the efficacy of the analgesic therapy.