Inclusion Criteria:

• Healthy on the basis of medical history and vital signs and meeting the American Society of Anesthesiology (ASA) physical status I, II, or III
• completed screening procedures and have undergone one of the following elective outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, or Bankart repair
• received regional anesthesia administered by interscalene nerve block
• receive study medication as the first oral analgesic medication following the orthopedic surgical procedure
• expected to have moderate to severe pain requiring oral opioids for at least 3 days after surgery

Exclusion Criteria:

• Patients whose post-operative pain would require non-opioid analgesia as standard of care
• received an inadequate block for the surgical procedure
• presence of a painful condition that could interfere with subject's assessments or ability to differentiate post-operative shoulder pain from other painful conditions or a condition associated with more severe pain in a location other than the surgical site
• took any of the following in the month before randomization: long-acting or controlled-release opioids, immediate-release Class II opioids (e.g.,Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid), intra-articular or systemic steroids except inhalers and topical steroids, or use of NSAIDS within 24 hours of randomization including intraoperative or post-operative NSAIDS (e.g., toradol)
• treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, serotonin norepinephrine reuptake inhibitors within 2 weeks before randomization