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.

Therapeutic blockade of greater occipital and supraorbital nerves in migraine patients.

A disturbance in the region of the head can provoke pain in the distribution of the trigeminal and upper cervical nerves due to a convergence of the afferent fibers of the three superior cervical roots on the neurones of the spinal nucleus of the trigeminal nerve. The therapeutic value of greater occipital and supraorbital nerve blockade in 27 patients with migraine, unresponsive to several combinations of pharmacological treatments, was investigated. Patients were given repeated anesthetic blocks, on alternate days, up to a maximum of 10 blocks. Perineural injections of 0.5 to 1.0 mL of 0.5% bupivacaine were given at the epicranial emergence points of the above nerves in relation to the distribution of the cephalic pain only if such nerves were conspicuously pain sensitive to pressure. Clinical evaluation was determined by a monthly Total Pain Index and recording of the number of migraine attacks and analgesic consumption each month. A patient was considered responsive when the Total Pain Index decreased by 50% or more in the first month after treatment. Twenty-three patients (85%) responded beneficially and maintained a favorable response for the 6-month period of observation. The treatment was considered to be of long-lasting effectiveness and without any side effects. Four patients (15%) were unresponsive to treatment. We hypothesize that the anesthetic blocks extinguished presumed foci of nociceptor discharges maintained by perivascular neurogenic inflammation, thereby reestablishing normal central neurone sensitivity. In conclusion, blockade of the supraorbital and greater occipital nerves appears to be effective in the treatment of migraine; however, controlled studies are needed to confirm these preliminary findings.

Treatment of postoperative pain with suprofen injected by the intramuscular route.

The analgesic effect and the tolerability of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) 200 mg/ml were compared with lysine acetylsalicylate 0.9 g/2.5 ml; the study included 60 subjects in severe to very severe pain following orthopedic surgery. The trial was performed in randomized single-blind fashion in patients who had given informed consent. The substances were injected into the upper out quadrant; maximally 4 intramuscular injections were given within 2 days. The test population was homogeneous with respect to the anamnestic data. The intensity of pain prior to treatment was comparable in both groups. Statistical analysis of the data revealed that suprofen was at the rating times (15 min to 4 h) significantly superior to the control groups. The investigator's and the patients' final appreciation indicated good to very good effect in 93% of the subjects on suprofen, and in 40 and 47%, respectively, of the patients in the control group. Here, too, suprofen was significantly superior to the reference Substance. Systemic and local tolerability of both drugs was very good. Adverse drug experience (heartburn) occurred in only 1 patient in the control group.