Clinical trial · Interventional
Symptom Management After Breast Cancer Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuropathic Pain | — | UNRESOLVED | — |
| Postmastectomy Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidoderm patch | Drug | — | UNRESOLVED |
| Placebo patch | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lidocaine Patch
- description
- Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
- interventionNames
- Drug: Lidoderm patch
- type
- PLACEBO_COMPARATOR
- label
- Placebo Patch
- description
- Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.
- interventionNames
- Drug: Placebo patch
Primary outcomes (1)
- measure
- Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available