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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Lidocaine Patch
Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
干预措施: Lidoderm patch (Drug)
Placebo Patch
Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
时间窗: Baseline, 12 weeks
Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).
次要结局
- Pain Interference With Function(12 weeks)