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Chronic pain is a common problem in clinical practice and women are affected more often than men. Morphine is often used for long-term pain relief, but it induces side effects including endocrine alterations. The aim of the present study was to assess the behavioural and hormonal effects of transdermal buprenorphine in women suffering from persistent non-malignant pain. Hormones (LH, FSH, total and free testosterone, estradiol, cortisol) and pain measures (visual analogue scale, McGill Pain questionnaire, present pain intensity test) were evaluated at baseline and after 1, 3 and 6 months. Subjects were recruited in the Second University of Naples Pain Research Centre. Eighteen chronic pain women were included in the study, divided into pre- and post-menopausal groups. A transdermal buprenorphine patch (Buprenorphine TDS, 35 µg/h) was administered every 72 h. As expected, buprenorphine administration led to a decrease in pain intensity and no side effects suggestive of hypogonadism were recorded. Pain measures decreased at the first control visit (T1) in both groups. Total and free testosterone were not reduced by treatment (they tended to increase in both groups) while cortisol progressively recovered from the quite low levels detected at the beginning of treatment. These data confirm that buprenorphine is a safe and effective drug for pain relief in women. It is free from the adverse effects on gonadal hormones frequently associated with other opioid treatments. The lack of opioid-induced effects on gonadal hormones (i.e., hypogonadism) is important to guarantee safe long-term pain treatment.

Background: Due to tolerance development and adverse side effects, chronic pain patients frequently need to be switched to alternative opioid therapy, Objective: To assess the efficacy and tolerability of an alternative transdermally applied (TDS) opioid in patients with chronic cancer pain receiving insufficient analgesia using their present treatment., Methods: A total of 32 patients received alternative opioid therapy, 16 were switched from buprenorphine to fentanyl and 16 were switched from fentanyl to buprenorphine. The dosage used was 50% of that indicated in equipotency conversion tables. Pain relief was assessed at weekly intervals for the next 3 weeks, Results: Pain relief as assessed by VAS, PPI, and PRI significantly improved (p < 0.0001) in all patients at all 3 follow up visits. After 3 weeks of treatment, the reduction in the mean VAS, PPI, and PRI scores in the fentanyl and buprenorphine groups was 68, 77, 74, and 69, 79, and 62%, respectively. Over the same time period the use of oral morphine as rescue medication was reduced from 27.5 +/- 20.5 (mean +/- SD) to 3.75 +/- 8.06, and 33.8 +/- 18.9 to 3.75 +/- 10.9 mg/day in the fentanyl and buprenorphine groups, respectively. There was no significant difference in either pain relief or rescue medication use between the two patient groups The number of patient with adverse events fell during the study. After the third week of the treatment the number of patients with constipation was reduced from 11 to 5, and 10 to 4 patients in the fentanyl and buprenorphine groups, respectively. There was a similar reduction in the incidence of nausea and vomiting. No sedation was seen in any patient after one week of treatment., Conclusion: Opioid switching at 50% of the calculated equianalgesic dose produced a significant reduction in pain levels and rescue medication. The incidence of side effects decreased and no new side effects were noted. Further studies are required to provide individualized treatment for patients according to their different types of cancer.

Aim: This study compared the efficacy and safety of buprenorphine transdermal delivery system with peridural infusion of morphine and ropivacaine to peridural infusion alone for the control of ischemic pain in patients suffering from peripheral vasculopathy., Methods: Eighty-six patients were randomized into two groups. In the first group, a buprenorphine patch 35 microg/hour TTDS (transtec transdermal device plus ropivacaine and morphine) was applied, and a peridural infusion of ropivacaine/morphine (200 mg + 2 mg) was established. In the second group, ropivacaine and morphine analgesia was obtained using a peridural infusion and a placebo patch. The primary efficacy parameter was the visual analog scale score for pain. Secondary parameters of efficacy were the short-form McGill Pain Questionnaire scores and a score for pain interference with sleep obtained from patient diaries evaluated every week for a period of 4 weeks., Results: Subjects in the TTDS group reported a reduction in pain, increased sleep, and a lower incidence of side effects compared with the control group., Conclusion: Transdermal buprenorphine use resulted in significant pain relief with excellent patient satisfaction, which may translate into improvement in mood and quality of life.

The aim of this randomized open-label prospective study was to evaluate the analgesic activity of buprenorphine in a transdermal formulation for cancer chronic pain control versus sustained-release morphine, in all cases combined with oral tramadol. A transdermal system with 35 microg/h buprenorphine was applied to the first group of patients (BT); the second group received 60 mg/day of sustained-release morphine (MT). In both groups oral tramadol was administered to a maximum of 200 mg daily, in case of need. The administration of transdermal buprenorphine versus morphine resulted in significant differences in the physical pain (P = 0.01), mental health (P = 0.03) and vitality (P = 0.001). These data indicated that the BT group showed an improvement of pain and a positive effect on the quality life.

The Aim: of this study was to evaluate the effectiveness and the safety of the association of buprenorphine transdermal delivery system (TDS) (Transtec TDS) and peridural infusion of morphine and naropine, for the control of ischemic pain in patients suffering from peripheral arteriopathy. The administration of an opioid, pure agonist, as morphine, with a partial agonist opioid, as the buprenorphine, was used. Buprenorphine has shown a higher liposolubility in supraspinal districts, while the morphine acts above all on the mu receptor subtype of the spinal cord. In this way it's possible a contemporary activation of spinal and supraspinal antinociceptive mechanisms. Furthermore, the incidence of side effects is reduced by buprenorphine, which antagonizes the central effect of morphine. In this study, 43 patients were recruited, suffering from chronic pain in Fontaine stage III-IV obstructive arteriopathy, scheduled for surgery. The patients have been divided into 2 equal groups for age, sex, pathology and intensity of pain. In the first group (TTDS), at first session, a buprenorphine patch 35 microg/h (Transtec TDS) has been applied, and after 24h, a peridural catheter with elastomeric system was positioned; 100 mL (2 mg/mL) of naropine and 2 mg of morphine, 4 mL/h in 24 h, were administered. In the second group (naropine morphine, NM), buprenorphine patch was not applied and analgesia was obtained only by using peridural catheter with elastomeric system at the same doses administered in the first group. At the daily control patients with visual analogical scale (VAS)=or>40 mm received an additional dose of morphine from 2 mg to 6+/-2 mg. VAS (0-100 mm) and the evaluation of the number of the hours of sleep were used to evaluate the analgesic effectiveness of the treatment. Side effects, opioid tolerance and abuse were always recorded. All parameters were evaluated daily for a period of 20+/-5 days. The results indicate that in group TTDS there was an improvement of pain symptomatology, also confirmed by the increased hours of sleep and the lower incidence of side effects. Instead in group NM, pain control was less effective, 18 patients needed a rescue dose of morphine, and the incidence of side effects increased.