Table 1. Investigation, observation, examination, and administration schedule.
| Procedure | Informed consent | Registration | Treatment period | End of study | Discontinuation | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Visit | – | 1 | 2 | 3 | 4 | 5 | 6 | 7 | – | |
| Week | – | 0 | 0 | 0 | 2 | 4 | 8 | 12 | – | |
| Day | – | 0 | 1 | 3 | 14 | 28 | 56 | 84 | – | |
| Visit window (days) | – | – | – | – | 8–21 | 22–35 | 50–63 | 78–91 | X−6–X+7 | |
| Informed consent | ○† | |||||||||
| Eligibility check | ○ | |||||||||
| Study treatment |
|
|||||||||
| Surgical information obtained | ○ | |||||||||
| Status of study drug administration | ○ | ● | ●‡ | ● | ● | ● | ||||
| Concomitant and prohibited medication check | ○ | ● | ●‡ | ● | ● | ● | ● | ● | ||
| VAS pain intensity (at rest and with cough) | ○ | ● | ●‡ | ● | ● | ● | ●# | |||
| VAS sleep disturbance | ○ | ● | ●‡ | ● | ● | ● | ●# | |||
| LANSS | ○ | ● | ● | ● | ●# | |||||
| PDAS | ○ | ● | ●# | |||||||
| EQ-5D-5L | ○ | ● | ●# | |||||||
| PGIC | ● | ●# | ||||||||
| Chronic pain | ● | ● | ●§ | |||||||
| Patient diary provided | ● | |||||||||
| Patient diary checked | ● | ●§ | ||||||||
| Discontinuation information | ● | |||||||||
| Adverse events |
|
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○ indicates items to be performed before the start of study treatment, and ● indicates items to be performed after the start of study treatment. †, informed consent will be obtained between the time of lung resection and the time of enrollment; ‡, Visit 3 should be performed as far as possible; #, to be performed only if discontinuation occurs before Visit 6; §, to be performed only if discontinuation occurs after Visit 6. Double-ended arrows indicates the duration of the study treatment and monitoring of adverse events. EQ-5D-5L, EuroQol 5-dimension 5-level measure; LANSS, Leeds Assessment of Neuropathic Symptoms and Signs; PDAS, Pain Disability Assessment Scale; PGIC, Patient Global Impression of Change; VAS, visual analog scale.