Cheville, A.L., Sloan, J.A., Northfelt, D.W., Jillella, A.P., Wong, G.Y., Bearden III, J.D., . . . Loprinzi, C.L. (2009). Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: A phase III double-blind crossover study (N01CB). Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 17(4), 451–460.

To investigate the efficacy of one or more lidocaine patches in reducing incisional pain

In the initial four-week treatment phase, patients received either lidocaine patches or placebo to apply to postsurgical incisional sites. After four weeks, the lidocaine group received placebo and vice versa. Pain was rated at baseline and at four and eight weeks.

• The sample was composed of 28 patients. 
• Mean patient age was 61.9 years.
• Nineteen patients (68%) were female. Nine patients (32%) were male.
• Eligible patients
  • Had experienced pain for one month or longer, and the pain rating was equal to or greater than 4.
  • Had pain with neuropathic features (e.g., burning, paresthesias, allodynia), pain involving an area that could be covered by three patches or fewer, pain related to a surgical site associated with cancer treatment.
  • Were at least 18 years old and had no recent history of drug or alcohol abuse.
  • Were expected to live for a period longer than six months.
  • Had no evident cognitive or psychiatric morbidity.
  • Were neither pregnant nor nursing.
• Patients were ineligible if their condition involved nonsurgical pain etiologies (e.g., malignancy, dermal pathology,  chemotherapy-induced neuropathy) at the painful site.

• Multisite
• Ten clinical centers
• United States

Double-blind, randomized, two-period crossover trial

• Rating of pain intensity
• Brief Pain Inventory (Short Form) (BPI-SF)
• Neuropathic Pain Scale (NPS)
• Patients' Global Impression of Change Scale
• Short-Form McGill Pain Questionnaire (SF-MPQ)
• Pain Catastrophizing Scale
• Profile of Mood States Short Form
• North Central Cancer Treatment Group Patient Quality-of-Life Linear Analog Self-Assessment Scale

• Average weekly pain intensity ratings were not significantly lower while patients used the lidocaine patch versus the placebo.
• BPI-SF interference scores were lower in patients receiving the lidocaine patch in the first period: general activity (p = 0.02), work (p = 0.04), relations with others (p = 0.02).

Pain interference scores were significantly lower in the group that received lidocaine patch first. Significant differences in postsurgical pain intensity, with the lidocaine patch applied to incisional areas, were lacking overall.

• The number of patches used varied.
• The study lacked power.
• Patients self-reported pain by means of telephone and email. Patients applied the patches themselves; whether they applied them correctly is unclear.
• In regard to weekly measures: Change may have occurred at times when measurements were not taken.

Further research is needed to determine whether lidocaine patches augment the analgesic regimen for incisional pain.