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. 2024 Feb 21;16(2):e54622. doi: 10.7759/cureus.54622

Table 1. Schedule of clinical study procedures and assessments.

a: Coagulation studies including PT, PPT, INR, and platelet count were estimated by point-of-care testing.

b: APRs IL-6, CRP, and D-dimer were measured.

c: Measured at 48 hours post-intervention.

d: Standard of care.

VAS: visual analog scale, ECG: electrocardiogram, PT: prothrombin time, PTT: partial thromboplastin time, INR: international normalized ratio, APR: acute phase reactants, IL-6: interleukin-6, CRP: C-reactive protein, SOC: standard of care

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