JPRN-jRCTs071200053已完成未知
Efficacy and safety of additional concomitant use of Mirogabalin in patients with neuropathic pain after thoracic surgery: multi-institutional, randomized, open, parallel assignment and interventional study
agayasu Takeshi0 个研究点目标入组 128 人开始时间: 2020年11月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
As a result of examining the efficacy and safety of additional concomitant use of Mirogabalin in patients with neuropathic pain after thoracic surgery, no further improvement in VAS was seen with the addition of Mirogabalin to conventional treatment. However, the addition of Mirogabalin was effective for improving ADL (PDAS) and QOL (EQ-5D-5L), and it was well tolerated in most patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients aged 20 years or older at informed consent
- •2)Patients who had pneumonectomy
- •3)Patients the day or two days after removing the thoracostomy tube placed by pneumonectomy, at enrollment
- •4)Patients with more 40mm of VAS for pain at rest around the surgical wound at enrollment
- •5)Patients with hypoesthesia of the cutaneous sensation innervated by surgical wound intercostal nerve at enrollment*
- •6)Patients who were confirmed to have no residual effects of epidural anesthesia at enrollment*
- •7)Patients who obtained their voluntary written consent after received a sufficient explanation and understood this study
- •*Confirm 5) and 6) according to the separately defined Procedure for Diagnosis of Peripheral Nerve Disorders after Surgery.
排除标准
- •1)Patients who had prior extrapleural pneumonectomy or decortication
- •2)Patients who have severe liver function failure at enrollment
- •3)Patients have with hypersensitivity to drugs allergies
- •4)Patients have pregnant, possibly pregnant, breast-feeding
- •5)Patients who took neuropathic pain medication from 1 month before surgery to enrollment
- •6)Patients with history of thoracotomy or thoracoscopic surgery, and before pneumonectomy in this study, patients with neuropathy due to the surgical history
- •7) Patients with a creatinine clearance (Cockcroft-Gault formula) < 30 mL/min within 3 months of enrollment
- •8)Patients with a history of hypersensitivity of Mirogabalin Besilate
- •9)Patients who had preoperative chemotherapy within 2 months before surgery
- •10)Patients with severe pain outside of around the surgical wound at enrollment and for whom efficacy evaluation in this study is difficult
- •11)Patients who are inappropriate for this study judged by Principal investigator or Sub investigator because of some reasons
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