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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
Open (Enrolling)
Female
Neuropathic Pain, Postmastectomy Pain

Thank you

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 CenterSan Francisco, California  94115