Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

Inclusion Criteria:

- Male or female patients who are 18 years of age or older

- Patients who are scheduled for an elective cemented or uncemented total unilateral
knee replacement or total unilateral hip replacement, under general or spinal
anesthesia that does not include use of an intrathecal opioid

- Post-surgical patients who have been admitted to the PACU and are expected to remain
hospitalized and to have acute post-operative pain requiring parenteral opioids for
at least 48 hours after surgery

Exclusion Criteria:

- Patients who have undergone a replacement of the same knee or hip

- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
hydrocodone per tablet)

- Patients with an allergy or hypersensitivity to opioids