Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

• Pain
• Hallux Valgus

• Drug: valdecoxib
  
  valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
• Drug: valdecoxib
  
  valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
• Drug: valdecoxib/placebo
  
  valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5

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

Inclusion Criteria:

• Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
• Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
• Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

• Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
• Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
• Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
• Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
• Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study