Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in VAS
研究概览
简要总结
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
详细描述
Breast cancer is the most common cause of cancer death for women . Postmastectomy pain syndrome (PMPS) is a frequent complication of breast surgery, and is considered a chronic neuropathic pain in the side of surgery which persists more than 3 months.
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.
The stellate ganglion (SG), also known as the cervico-thoracic ganglion, is part of the sympathetic nervous system.
After assessment of eligibility criteria a predetermined randomization list and will be generated using random blocks.
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice has to be 0.5 cm apart from each other . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
- Group A ,The procedure will be started by placing the needle tip аntеrоlаteral to the lоngusсоlli muscle, dееp to the prеvеrtebrаlfаsсia in оrdеr tо аvоid spread along the carotid sheath, but superficial to the fascia investing the longus colli muscle (to prevent injecting into the muscle). Identifying the correct fascial plane achieved with portable ultrasound guidance thus facilitating the caudal spread of the injectate to reach the stellate ganglion at the C7-T1 level. This allowed for a more effective and stable sympathetic block with the use of a small injected volume. As an injection, we firstly used 1%-2.0 ml of lidocaine. The procedure will be continued by the injection of ethanol 50%, in quantity 1.5 ml for a lasting effect.
- Group B, thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patient 20-65yrs underwent surgery for breast cancer
- •Pain duration of more than 6 months
- •Pain is moderate to severe pain (visual analog scale [VAS] ≥ 4 cm),
- •Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective
- •Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4
排除标准
- •Refusal of the patient
- •Recent myocardial infarction
- •Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio)
- •Pre-existing counter lateral nerve palsy
- •Severe emphysema
- •Cardiac conduction block
- •Local and systemic sepsis
- •Local anatomical distortion (which may render the block technically difficult or hazardous.
- •Psychiatric illness.
结局指标
主要结局
Changes in VAS
时间窗: 12 WEEKS
assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks . A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 100 mm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
次要结局
- patient satisfaction by patient satisfaction score and the analgesic concomitant medications consumption will be assessed before and 1,4,8 and 12 weeks after block(12 weeks)