Schedule of activities
Protocol activity | Screen | Baseline Randomisation Day 1 | Surgery Day 0 | Day 1 | Day 2 | Day 3 | Day 4 | Week 2 | Week 4 | Week 6 | Week 12 |
---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
Informed consent | X | ||||||||||
Demography | X | ||||||||||
Medical and surgical history | X | ||||||||||
Physical examination | X | X | X | X | X | ||||||
Vital signs | X | X | X | X | X | X | X | X | X | X | |
Haematology | X | X | X | ||||||||
Blood chemistry | X | X | X | ||||||||
Urinalysis | X | X | X | ||||||||
Pregnancy test* | X | X | |||||||||
ECG | X | X | X | ||||||||
ESR and CRP | X | X | X | X | X | ||||||
Blood coagulation | X | X | X | X | X | ||||||
Peripheral blood cytokine concentration | X | X | X | X | X | X | X | ||||
VAS | X | X | X | X | X | X | X | ||||
EQ-5D | X | X | X | X | X | ||||||
Knee circumference and skin temperature | X | X | X | X | X | X | X | ||||
X-ray | X | ||||||||||
Echocardiogram | X | ||||||||||
Pulmonary function | X | ||||||||||
Ultrasound tests | X | ||||||||||
Blood transfusion tests | X | ||||||||||
WOMAC and KSS | X | X | X | X | X | ||||||
Inclusion/exclusion criteria | X | X | |||||||||
Registration/randomisation | X | X | |||||||||
Hospital admission | X | ||||||||||
Surgery—total knee arthroplasty | X | ||||||||||
Synovial fluid cytokine concentration | X | X | X | ||||||||
Infusion of parecoxib or placebo 40 mg two times a day | X | X | X | ||||||||
Record morphine consumption | X | ||||||||||
Celebrex/placebo 200 mg two times a day | X------------X | ||||||||||
Recording the cumulative tramadol consumption | X | X | X | X | X | X | |||||
Adverse event | X | X | X | X | X | X | X | X | X | X† |
The Schedule of Activities table provides an overview of the protocol visits and procedures. Refer to Study Procedures (Section 6) and Assessments (Section 7) for detailed information on each procedure and assessment required for compliance with the protocol.
CRP, C reactive protein; ESR, erythrocyte sedimentation rate; EQ-5D, Eurocol-5D; VAS, visual analogue scale.
*Pregnancy tests may be repeated as per request of Ethics Committee or if required by local regulations. † telephone follow-up.