Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Incidence of Post-Mastectomy Pain Syndrome
研究概览
简要总结
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain.
Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.
- •Patients with no prior diagnosis of PMPS.
排除标准
- •Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.
- •Recent chest radiation (<6 months), severe scarring, or active infection.
- •Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.
- •Psychiatric or cognitive impairments.
- •Pregnancy, or active lactation.
- •Autologous tissue based breast reconstruction.
- •Participation in another study within 6 months or inability to comply with follow-up.
结局指标
主要结局
Incidence of Post-Mastectomy Pain Syndrome
时间窗: Pre-operative visit (baseline) to 12 months.
Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.
次要结局
- Breast Cancer Pain Questionnaire(Pre-operative visit (baseline) to 12 months.)
- Adverse event rates(Pre-operative visit (baseline) to 12 months.)
研究者
Kari Colen
Medical Doctor
Advanced Reconstructive Surgery Alliance