Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reduction of pain
研究概览
简要总结
Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.
Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.
Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.
- 24 hours after the procedure - assessment of pain intensity and quality of life
- 7 days after the procedure - assessment of pain intensity
- 30 days after the procedure - assessment of pain intensity and quality of life
- 3 months after the procedure - assessment of pain intensity
- 6 months after the procedure - assessment of pain intensity and quality of
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Status post amputation of a lower or upper limb
- •Pain related to amputation as determined by referring physician and investigator
- •Informed consent of patient to enter the study
- •Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure
排除标准
- •Pregnancy
- •Active infection in the area of the planned intervention
- •Blood coagulation disorders
- •Immunosuppression
- •Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
- •Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
- •Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
- •No reduction of pain after the diagnostic block of the relevant main peripheral nerves
研究组 & 干预措施
cryoablation
peripheral nerve cryoablation
干预措施: cryoablation (Procedure)
结局指标
主要结局
Reduction of pain
时间窗: T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.
Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale). Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from '0' (minimum, "no pain") to '10' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.
次要结局
- The quality of life (SF-36)(A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.)
- The quality of life (AIS)(A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.)
研究者
Dariusz Tomaszewski
Adjunct professor
Military Institute od Medicine National Research Institute