Table 1

Schedule of activities

Protocol activityScreenBaseline
Randomisation
Day 1
Surgery
Day 0
Day 1Day 2Day 3Day 4Week 2Week 4Week 6Week 12
Visit12345678910
Informed consentX
DemographyX
Medical and surgical historyX
Physical examinationXXXXX
Vital signsXXXXXXXXXX
HaematologyXXX
Blood chemistryXXX
UrinalysisXXX
Pregnancy test*XX
ECGXXX
ESR and CRPXXXXX
Blood coagulationXXXXX
Peripheral blood cytokine concentrationXXXXXXX
VASXXXXXXX
EQ-5DXXXXX
Knee circumference and skin temperatureXXXXXXX
X-rayX
EchocardiogramX
Pulmonary functionX
Ultrasound testsX
Blood transfusion testsX
WOMAC and KSSXXXXX
Inclusion/exclusion criteriaXX
Registration/randomisationXX
Hospital admissionX
Surgery—total knee arthroplastyX
Synovial fluid cytokine concentrationXXX
Infusion of parecoxib or placebo 40 mg two times a dayXXX
Record morphine consumptionX
Celebrex/placebo 200 mg two times a dayX------------X
Recording the cumulative tramadol consumptionXXXXXX
Adverse eventXXXXXXXXXX†
  • 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.