Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

• Drug: valdecoxib
  
  valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
• Drug: valdecoxib/placebo
  
  valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
• Drug: placebo
  
  placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

• Active Comparator: Arm 1
  
  Intervention: Drug: valdecoxib
• Active Comparator: Arm 2
  
  Intervention: Drug: valdecoxib/placebo
• Placebo Comparator: Arm 3
  
  Intervention: Drug: placebo

Inclusion Criteria:

• Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
• Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ?45 mm on a VAS

Exclusion Criteria:

• Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
• Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
• Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
• Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids