Super-voltage Pulsed Radiofrequency of Stellate Ganglion Versus Super-voltage Pulsed Radiofrequency of T2 T3 Sympathetic Ganglia in Managing Postmastectomy Pain Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in VAS score in groups
研究概览
简要总结
The aim of this study is to compare the effectiveness of super-voltage pulsed radiofrequency of stellate ganglion and super-voltage pulsed radiofrequency of T2-T3 sympathetic ganglia in the treatment of postmastectomy pain syndrome.
详细描述
Rationale for our study:
Supervoltage Pulsed Radiofrequency (SV-PRF) is an advanced neuromodulation technique that delivers higher-voltage short pulses (typically 60-90 V) while keeping tissue temperature below neurodestructive levels (<42°C), allowing deeper electric-field penetration, enhanced C-fiber modulation, and sustained changes in sympathetic outflow without causing structural nerve injury, theoretically providing longer-lasting analgesia and improved safety compared to standard PRF. Among interventional options for sympathetically mediated PMPS, stellate ganglion (SGB) and T2-T3 sympathetic interventions have emerged as promising therapies, yet they differ in mechanism, outcomes, and clinical implications. The current literature lacks direct head-to-head comparisons of these two techniques regarding efficacy, long-term relief, and safety, as most studies evaluate each intervention individually. This knowledge gap, combined with the limited efficacy of conventional pharmacologic treatments, highlights the need for a comparative study to determine which approach offers superior pain relief, durability, safety, and cost-effectiveness. By examining short- and long-term outcomes, as well as resource utilization, this study aims to provide evidence-based guidance to optimize clinical decision-making, help clinicians select the most appropriate intervention for PMPS patients, and establish practical, sustainable treatment strategies. .(33, 34)
Aim of the study:
The aim of this study is to compare the effectiveness of supervoltage pulsed radifrequency of stellate ganglion and supervoltage pulsed radifrequency of T2-T3 sympathetic ganglia in the treatment of postmastectomy pain syndrome.
Primary Objectives:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-60 years.
- •Patient of class II according to the American society of Anesthesiologists (ASA) physical status classification system.
- •History of unilateral mastectomy for breast cancer.
- •Persistent pain >3 months postoperatively.
- •VAS score ≥4 despite pharmacological management.
- •Patients with neuropathic pain who has a score ≥4 by (DN4) questionnaire.
- •Patients on more than 1 antineuropathic drug.
排除标准
- •Coagulopathy or anticoagulant therapy.
- •Local infection at injection site.
- •History of psychiatric illness or cognitive dysfunction.
- •Previous intervention in the same region (e.g., prior stellate ganglion block or thoracic radiofrequency ablation).
- •Allergy to local anesthetics or contrast agents.
结局指标
主要结局
Change in VAS score in groups
时间窗: 6 months
Change in visual analogue scale score in groups at different time intervals (baseline, 1 week, 1 month, 3 months, 6 months)
次要结局
- Change in Brief Pain Inventory in groups.(6 months)
- Patient satisfaction(6 months)
- dose reduction in antineuropathic drugs(6 months)
- procedural complications.(6 months)
研究者
Ahmed Mohamed Soliman
Assistant professor of anesthesia and pain management
National Cancer Institute, Egypt