Time point** | Study period | ||||||
---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | ||||
D-1 | D0 | D0 | D1 | D7 | D28 | D28 | |
Enrollment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Inclusion and non-inclusion criteria | X | ||||||
Allocation | X | ||||||
Interventions | |||||||
Control group | X | X | |||||
Experimental group | X | X | |||||
Assessments | |||||||
Clinical data | X | ||||||
Pain intensity (NRS scale) | X | X | X | X | |||
Dose of analgesics | X | X | |||||
Postoperative complications (POMS) | X | X | |||||
Vital status | X | X |