A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Study Overview
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Brief Summary
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The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Official Title
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A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Conditions
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Post-Operative Pain

Intervention / Treatment
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* Drug: Sufentanil NanoTab PCA System/15 mcg
* Drug: morphine IV PCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients who are 18 years or older Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. 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 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 Female patients who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil NanoTab PCA System/15 mcg<br> | Drug: Sufentanil NanoTab PCA System/15 mcg<br>* 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours<br>* Other names: Zalviso™;|
| Active Comparator: morphine IV PCA<br> | Drug: morphine IV PCA<br>* 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Satisfaction | Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult post-operative inpatients who, are expected to require parenteral, opioid analgesia for at least 48, or hip/knee replacement surgery, hours after open abdominal surgery