Phase 3
Completed N=419
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
Post Operative Pain
Source: ClinicalTrials.gov NCT01660763 ↗
Enrolled (actual)
419
Serious AEs
2.9%
Results posted
Feb 2014
Primary outcomePrimary: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). — 76.24; -11.35 Units on a scale — p=<0.001
Summary
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). |
76.24; -11.35 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01660763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.