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Clinical Trial
. 2009 Apr;17(4):451-60.
doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13.

Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB)

Andrea L Cheville  1 , Jeff A Sloan, Donald W Northfelt, Anand P Jillella, Gilbert Y Wong, James D Bearden Iii, Heshan Liu, Paul L Schaefer, Benjamin T Marchello, Bradley J Christensen, Charles L Loprinzi
Affiliations
Clinical Trial

Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB)

Andrea L Cheville et al. Support Care Cancer. 2009 Apr.

Abstract

Objective: Current therapies often have limited efficacy and untenable side effects when used to treat persistent incisional pain following cancer-related surgery. Lidocaine patches reduce neuropathic pain from herpes zoster but their benefits for persistent cancer-related postsurgical incisional pain remain unclear.

Study design: Multicenter, double-blind, randomized, two-period crossover trial.

Materials and methods: Twenty-eight cancer patients with postsurgical incisional pain were randomly assigned to receive either lidocaine patches followed by placebo patches or the reverse. Each study period lasted 4 weeks. Patches were applied daily upon waking and left in place for a maximum of 18 h. The primary outcome measure, an 11-point pain intensity rating scale, was administered weekly. Secondary outcomes were administered weekly (Brief Pain Inventory-Short Form(BPI-SF), Subject Global Impression of Change) and at the end of each study period (Short Form-Magill Pain Questionnaire, Linear Analogue Self Assessment Scale, Neuropathy Pain Scale, Pain Catastrophizing Scale, Profile of Mood States Short Form).

Results: Twenty-one patients completed the first period and 18 completed their crossover second phase. No significant intergroup differences were detected in pain intensity ratings. Few secondary end points were significantly different when subjects used the lidocaine versus placebo patches. BPI-SF interference scores were lower in patients using the lidocaine patch during the first study period, including several scores that achieved statistical significance, general activity (p = 0.02), work (p = 0.04), and relations with others (p = 0.02).

Conclusion: Lidocaine patch use did not significantly reduce pain intensity ratings or the majority of related secondary end points in cancer patients with persistent incisional pain.

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Figures

Fig. 1
Fig. 1
Study participant flow
Fig. 2
Fig. 2
Mean pain intensity rating changes from baseline for: a average, b worst, c least, and d current weekly pain scores
Fig. 3
Fig. 3
Mean Brief Pain Inventory overall pain interference changes from baseline
See this image and copyright information in PMC

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