Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The degree of pain relief
研究概览
简要总结
The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).
详细描述
Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.
Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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.
- •Type of surgery: Modified Radical Mastectomy MRM.
- •Physical status ASA II, III.
- •Duration of more than 6 months and less than 2 years.
- •Moderate and severe pain (visual analog scale [VAS] ≥ 40 mm).
- •Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.
排除标准
- •Patient refusal.
- •Patient with local and systemic sepsis.
- •Local anatomical distortion.
- •History of contralateral chest disease or pneumonectomy.
- •Known sensitivity or contraindication to the drug used in the study.
- •History of psychological disorders.
- •Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.
- •Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
- •Pregnancy.
- •Physical status ASA IV and Male patients.
结局指标
主要结局
The degree of pain relief
时间窗: 3 months after intervention
Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention. Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.
次要结局
- Patient satisfaction(3 months after intervention)
- Patient's Quality of life(3 months)
- neuropathic pain(3 months)
- Oxycodone consumption(3 months after intervention)
- Pregabalin consumption(3 months after intervention)
研究者
Mary Sabry
Assistant lecturer of Anesthesia, ICU and Pain Management
National Cancer Institute, Egypt