Cooled Radiofrequency in Comparison to Either Conventional Radiofrequency Thermocoagulation or Neurolytic Block of Ganglion Impar in the Management of Perineal Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
研究概览
简要总结
Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
- •The intensity of perineal pain on VAS score ≥
- •Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
- •Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score > 50% at least for 2 hours.
排除标准
- •Infection of the skin at or near site of needle puncture.
- •Coagulopathy or prolonged bleeding time.
- •Drug hypersensitivity or allergy to the studied drugs.
- •Central or peripheral neuropathy .
- •Significant organ dysfunction as respiratory , liver or renal failure.
- •Any psychiatric illness that would interfere with the perception and the assessment of pain.
- •Vertebral anomalies.
结局指标
主要结局
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
时间窗: 2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.
Patients rate pain on a scale from 0-10, 0 being no pain and 10 being the worst pain imaginable.
次要结局
- Total Tramadol consumption(at 2 weeks, 1 month, 2 months and 3 months' post procedural.)
研究者
Aya Abo eldahab Ali elden
Aya Abo Eldahab
Assiut University