Table 1. Schedule of clinical study procedures and assessments.
Procedure | Screening | Baseline | 6 hours | 12 hours | 24 hours | 36-48 hours | 48-72 hours | 1 week | Discharge |
Inclusion/exclusion | X | X | X | ||||||
Informed consent | X | ||||||||
Demographics | X | ||||||||
Medical history | X | ||||||||
Physical examination including ECG | X | X | X | ||||||
Hemoglobin and coagulation profilea | X | X | X | ||||||
Sampling for CRPb, IL-6, and D-dimer | X | X | X | Xc | X | ||||
Sampling for serum cortisol | X | X | X | X | |||||
Randomization | |||||||||
Intervention (epidural analgesia or SOCd) | X | X | X | X | X | ||||
Adverse events | X | X | X | X | |||||
VAS scoring | X | X | X | X | X | ||||
Likert scoring | X |