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
- Conditions
- Post-Operative Pain
- Interventions
- Drug: Placebo Sufentanil NanoTab PCA System
- Registration Number
- NCT01539642
- Lead Sponsor
- Talphera, Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sufentanil NanoTab PCA System/15 mcg Sufentanil NanoTab PCA System/15 mcg - Placebo Sufentanil NanoTab PCA System Placebo Sufentanil NanoTab PCA System -
- Primary Outcome Measures
Name Time Method Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). 48 hours SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.
Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours.
Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
G&G Research
🇺🇸Vero Beach, Florida, United States
Surgical Associates of Mobile
🇺🇸Mobile, Alabama, United States
Caring Clinical Research Corporation
🇺🇸Laguna Hills, California, United States
Jefferson Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Rush Pain Center
🇺🇸Chicago, Illinois, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Memorial Hermann -Memorial City Medical Center
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Phoenix OB GYN Associates
🇺🇸Moorestown, New Jersey, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States