- 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
- 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