Neuropathic pain
Conditions
Interventions
Patients who meet the enrollment requirements are randomized by the enrollment system to one of the following treatment groups using the substitution block method (ratio 1:1). The VAS (less than 60 mm
Sponsors
Nagayasu Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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".
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in pain intensity (VAS) Visual analog scale of pain at rest around the surgical wound; Amount of change in VAS (100 mm scale with 0 mm for no pain and 100 mm for the worst pain you can imagine) 8 weeks after registration | — |
Secondary
| Measure | Time frame |
|---|---|
| (Effectiveness) 1)Percentage of patients with the following evaluation scales improved by 30% or more and 50% or more based on enrollment - VAS of pain around the surgical wound at rest (after 8 weeks) 2)Percentage of patients with a rating scale of 12 or more based on enrollment - S-LANSS (after 2 weeks, 4 weeks, 8 weeks) 3)Amount of change in the following evaluation scales based on enrollment - VAS of pain at rest (after 1 day, 2 weeks, 4 weeks) - VAS of pain when coughing (after 1 day, 2 weeks, 4 weeks, 8 weeks - PDAS (after 8 weeks) - EQ-5D-5L (after 8 weeks) - VAS of sleeping disorder (after 1 day, 2 weeks, 4 weeks, 8 weeks) 4)Changes in the patient's general conditions (PGIC) (after 8 weeks) 5)Prevalence of chronic pain : Prevalence of chronic pain at 8 weeks and 12 weeks after enrollment in each treatment group. | — |
Contacts
Public ContactRyoichiro Doi
Nagasaki University Hospital
Outcome results
None listed