Phase 4
Completed N=21
Symptom Management After Breast Cancer Surgery
Postoperative Pain · Postmastectomy Pain
Source: ClinicalTrials.gov NCT00686127 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks — 4.0 units on a scale
Summary
This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks |
4.0 | — |
| SECONDARY Pain Interference With Function |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00686127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.