The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Underwent surgical procedure for cancer diagnosis or treatment

- Experiencing persistent pain for at least 1 month

- Pain must have neuropathic features (e.g., burning, shooting, stabbing,
tingling, or pain from light touch)

- Anatomically related to the surgical site and compatible with nerve injury

- Pain rating of at least 4 out of 10 on the pain scale

- No pain of multiple etiologies at the proposed treatment site (e.g., pain of
neuropathic and muscular or skeletal origin)

- Painful area must be no larger than can be covered by 3 lidocaine patches* NOTE:
*Each patch size is 5.5 x 4 inches

- No skin disease, breakdown, infection, or extreme thinning at the site of pain

- No skin or soft tissue malignancy in the painful area

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- At least 6 months

Hematopoietic

- Not specified

Hepatic

- AST ≤ 2 times upper limit of normal

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to understand and complete questionnaires

- No recent history of or concurrent drug or alcohol abuse

- No mental or psychiatric condition that would preclude giving informed consent

- No history of allergic reaction or intolerance to lidocaine or other amide local
anesthetics (e.g., bupivacaine)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior neurotoxic chemotherapy* with pain in the same area as postsurgical
neuropathic pain, except for pain that was present before neurotoxic chemotherapy
administration

- No concurrent neurotoxic chemotherapy* NOTE: *Including taxanes (e.g., paclitaxel or
docetaxel), platinum-based compounds (e.g., cisplatin or carboplatin), or vinca
alkaloids (e.g., vincristine or vinblastine)

Endocrine therapy

- More than 7 days since prior topical corticosteroids to the painful area

- No new corticosteroids may be initiated during study participation

Radiotherapy

- No concurrent radiotherapy to the painful area

Surgery

- See Disease Characteristics

Other

- More than 7 days since other prior topical medications to the painful area (including
capsaicin)

- No change in current analgesic regimen within the past 10 days

- No new analgesic or adjuvant drugs (e.g., antidepressants, anticonvulsants, or
anxiolytics) may be initiated during study participation

- Concurrent stable doses of nonopioid, opioid, and adjuvant analgesic drugs are
allowed (including antidepressants or anticonvulsants)

- No concurrent class I antiarrhythmic drugs (e.g., tocainide and mexiletine)

- Concurrent skin lubricants and sunscreen are allowed provided they are not heavily
applied