Pain relief with lidocaine 5% patch in localized peripheral neuropathic pain in relation to pain phenotype: a randomised, double-blind, and placebo-controlled, phenotype panel study : PAIN

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Research Paper

Pain relief with lidocaine 5% patch in localized peripheral neuropathic pain in relation to pain phenotype

a randomised, double-blind, and placebo-controlled, phenotype panel study

Demant, Dyveke T.a; Lund, Karenb; Finnerup, Nanna B.b; Vollert, Janc; Maier, Christophc; Segerdahl, Märtha S.d,e; Jensen, Troels S.b; Sindrup, Søren H.a,*

Author Information

aDepartment of Neurology, Odense University Hospital, Odense, Denmark

bDanish Pain Research Centre, Aarhus University Hospital, Aarhus, Denmark

cDepartment of Pain Medicine, Bergmannsheil Hospital, Ruhr-University Bochum, Bochum, Germany

dH. Lundbeck A/S, Copenhagen, Denmark

eDepartment of Physiology and Pharmacology, Karolinska Institute, Stockholm, Sweden

Corresponding author. Address: Department of Neurology, Odense University Hospital, DK-5000 Odense, Denmark. Tel.: +45 6541 2471; fax: +45 6541 3389. E-mail address: [email protected] (S. H. Sindrup).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Received January 28, 2015

Received in revised form May 20, 2015

Accepted June 08, 2015

PAIN 156(11):p 2234-2244, November 2015. | DOI: 10.1097/j.pain.0000000000000266

In neuropathic pain with irritable nociceptor (IN) phenotype, upregulation of sodium channels on nociceptors is supposed to be an important pain mechanism that may be targeted by topical sodium channel blockade. This randomised, double-blind, phenotype panel, crossover study with 4-week treatment periods of lidocaine 5% patch and placebo was performed to search for phenotype differences in effect. The primary efficacy measure was the total pain intensity on an 11-point numeric rating scale, and the primary objective was to compare the effect of lidocaine in patients with and without IN phenotype as defined by hypersensitivity and preserved small-fibre function determined by quantitative sensory testing. Forty-six patients with neuropathic pain due to nerve injury or postherpetic neuralgia were randomised. The modified intention-to-treat population comprised 15 patients with irritable nociceptor and 25 patients with nonirritable nociceptor. In the total sample, lidocaine reduced pain by 0.3 numeric rating scale points (95% confidence interval [CI]: 0.1-0.5) and pain-related sleep disturbance by 0.6 points (95% CI: 0.4-0.8) more than placebo (P = 0.007 and P < 0.001) and relieved pain by 0.4 verbal score (−1-5) points more (P = 0.036). For these measures, there was no significant interaction between treatment and phenotype, but there was a significant interaction for pain paroxysms (0.8, 95% CI: 0.4-1.2, P < 0.001) and deep aching pain (0.6, 95% CI: 0.1-1.0, P = 0.013). In conclusion, lidocaine 5% patch had an effect on peripheral neuropathic pain, and it may be most efficacious in patients with IN phenotype. The lack of significant phenotype differences may be caused by too low statistical power.

© 2015 International Association for the Study of Pain

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