Background: Evidence-based pharmacological treatment options for patients with persistent inguinal postherniorrhaphy pain are lacking.
Methods: Twenty-one male patients, with severe, unilateral, persistent inguinal postherniorrhaphy pain, participated in a randomized, double-blind, placebo-controlled crossover trial, receiving lidocaine patch (5%) and placebo patch treatments in periods of 14 days separated by a 14-day wash-out period. Pain intensities (at rest, during movement, and pressure evoked [Numerical Rating Scale]) were assessed before treatment and on the last 3 days of each treatment period. Patients were a priori divided into two subgroups based on quantitative sensory testing (+/− thermal “hyposensitivity”). Skin biopsies for intraepidermal nerve fiber density assessment were taken at baseline, and quantitative sensory testing was performed before and after each treatment period. The primary outcome was change in pain intensity assessed as the difference in summed pain intensity differences between lidocaine and placebo patch treatments.
Results: There was no difference in summed pain intensity differences between lidocaine and placebo patch treatments in all patients (mean difference 6.2% [95% CI = −6.6 to 18.9%]; P = 0.33) or in the two subgroups (+/− thermal “hyposensitivity”). The quantitative sensory testing (n = 21) demonstrated an increased pressure pain thresholds after lidocaine compared with placebo patch treatment. Baseline intraepidermal nerve fiber density (n = 21) was lower on the pain side compared with the nonpain side (−3.8 fibers per millimeter [95% CI = −6.1 to −1.4]; P = 0.003). One patient developed mild erythema in the groin during both treatments.
Conclusions: Lidocaine patch treatment did not reduce combined resting and dynamic pain ratings compared with placebo in patients with severe, persistent inguinal postherniorrhaphy pain.