• Vincenzo Pota, Manlio Barbarisi, Pasquale Sansone, Marco Moraci, Maria Caterina Pace, Maria Beatrice Passavanti, and Caterina Aurilio.
• Department of Anaesthesiological, Surgical & Emergency Sciences, Second University of Naples, Piazza Miraglia 2, 80138 Napoli, Italy.
• Pain Manag. 2012 Jan 1;2(1):23-31.

UnlabelledSUMMARY AimThe aim of this study was to evaluate the efficacy and safety of combined transdermal buprenorphine and pregabalin in chronic low back pain.Patients & MethodsA total of 45 patients with chronic low back pain were recruited into the study. For an initial 3-week period, all patients received transdermal buprenorphine 35 µg/h. After 3 weeks of only transdermal buprenorphine 35 µg/h, patients were randomized (single-blind) to receive transdermal buprenorphine 35 µg/h plus pregabalin 300 mg/day (group A) or transdermal buprenorphine 35 µg/h plus placebo (group B), and were observed for a further 3-week period. Efficacy parameters were weekly mean Visual Analog Scale (VAS) scores, the Pain Rating Index (PRI) of the Short-Form McGill Pain Questionnaire (SF-MPQ), the Present Pain Index (PPI) of the SF-MPQ and sleep interference. We also evaluated the use of rescue medication (paracetamol [acetaminophen]) and the presence of adverse events.ResultsA total of 44 patients were evaluated for efficacy and safety parameters. Pain relief, as assessed by VAS, PPI and PRI, improved significantly (p < 0.05) in all patients after the first week of treatment with only transdermal buprenorphine. Following randomization, only patients in group A showed further reductions in the mean VAS, PPI and PRI scores. Moreover, patients in group A had a lower consumption of rescue medication than those in group B. There was a low incidence of mild adverse events in both group A and group B, with no serious adverse events in either group.ConclusionPregabalin 300 mg/day as an add-on to transdermal buprenorphine 35 µg/h led to significant pain reduction and a significant reduction of interference with sleep quality in patients with chronic low back pain.

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