ADMIT-NeP Study
- Conditions
- europathic pain
- Registration Number
- JPRN-jRCTs071200053
- Lead Sponsor
- agayasu Takeshi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 128
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method