Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.
详细描述
Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from upper abdominal cancer pain.
- •Visceral pain with visual analogue pain score ≥
- •Normal coagulation profile.
- •Positive diagnostic test.
- •Written informed consent from the patients .
排除标准
- •Patients with organ failure.
- •Coagulation disorders.
- •Local infection at the puncture site or sepsis.
- •Allergy to the contrast dye or alcohol.
- •Severe displacement of intra-abdominal structures.
- •Pregnant women.
- •Documented metastatic lesions.
- •Psychiatric illness affecting cooperation.
- •De-compensated cardiac disorders.
- •Liver and renal dysfunction.
研究组 & 干预措施
Group 1( radiofrequency group )
Bilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion
干预措施: Radiofrequency generator device (Device)
Group 1( radiofrequency group )
Bilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion
干预措施: Lidocaine (Drug)
Group 2 ( alcohol group )
Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
干预措施: C arm fluoroscopic device (Device)
Group 2 ( alcohol group )
Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
干预措施: Ethyl alcohol (Drug)
结局指标
主要结局
Pain relief
时间窗: 3 months
Visual analogue pain scale
次要结局
- Decrease the need for analgesic drugs(3 months)
研究者
Fatma Al Zahraa Hamed Abdel Hameed
Lecturer of anasthesia and pain relief
South Egypt Cancer Institute