- 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
- 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