Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in visual Analogue Scale (VAS )
研究概览
简要总结
this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.
详细描述
Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post-mastectomy pain syndrome.
Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (18-65) Years.
- •American Society of Anesthesiologists (ASA) physical status (II- III).
- •Patients with post mastectomy shoulder pain.
- •Body mass index (BMI): (20-40) kg/m
- •Patients on maximum daily dose tramadol ( 450mg ) and still in pain
排除标准
- •Patient refusal.
- •Known sensitivity or contraindication to drugs used in the study.
- •Pregnancy.
- •Recent myocardial infarction.
- •Hemodynamically unstable.
- •Local and systemic sepsis.
- •Psychiatric illness.
研究组 & 干预措施
Brachial plexus pulsed radiofrequency group
Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.
干预措施: Brachial plexus pulsed radiofrequency (Other)
Sholder individual nerves pulsed radiofrequency group
Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
干预措施: Sholder individual nerves pulsed radiofrequency (Other)
Control group
Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs .
干预措施: Control (Other)
结局指标
主要结局
Changes in visual Analogue Scale (VAS )
时间窗: 24 weeks post postoperatively
Changes in visual Analogue Scale (VAS )for assessment of pain relief. A 100 mm horizontal line version will be used with 2 ends (left-end means no pain and right-end means the worst pain). This version is preferred in research studies for chronic pain status.
次要结局
- Analgesic consumption(24 weeks post postoperatively)
- Patient satisfaction(24 weeks post postoperatively)
- Incidence of complications(24 weeks post postoperatively)
- Functional improvement(24 weeks post postoperatively)
- The impact of treatment on the quality of life of the patient(24 weeks post postoperatively)
研究者
Yasmina Sayed
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management Department, National Cancer Institute, Cairo University, Egypt.
Cairo University