Phase 3
Completed N=172
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
Post-Operative Pain
Source: ClinicalTrials.gov NCT01539642 ↗
Enrolled (actual)
172
Serious AEs
0.6%
Results posted
Feb 2014
Primary outcomePrimary: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). — 105.60; 55.58 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 open abdominal surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). |
105.60; 55.58 | 0.001 sig |
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT01539642). 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.