A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Neuropathic Pain, Postmastectomy Pain
Female
Neuropathic Pain, Postmastectomy Pain
Trial Information
A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery
Inclusion Criteria:
- Adult women >18 years who develop neuropathic pain in the breast scar area and/or
ipsilateral arm following breast cancer surgery
- Has a healed incision(s)
- Has no recurrent disease in the painful area
- Is able to read, write and understand English
Exclusion Criteria:
- Presence of another type of pain that is more severe than the neuropathic pain
- Use of an opioid analgesic of greater than 60 mg codeine/day
- Is actively trying to become pregnant
- Has a medical contraindication to the use of lidocaine
- Has an allergy to lidocaine
- Is taking a coanalgesic for neuropathic pain.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
pain intensity
Outcome Time Frame:
12 weeks
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
Breast Pain
NCT ID:
NCT00686127
Start Date:
September 2003
Completion Date:
December 2013
Related Keywords:
- Neuropathic Pain
- Postmastectomy Pain
- breast cancer
- neuropathic pain
- topical lidocaine
- postmastectomy pain
- breast symptoms
- breast pain
- Breast Neoplasms
- Neuralgia
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
