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A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.
Details
| Lead sponsor | Durect |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2008-12 |
| Completion | 2009-10 |
Conditions
- Postoperative Pain
Interventions
- SABER-Bupivacaine
- SABER-Placebo
Primary outcomes
- Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose. — 0 to 72 hours post-dose
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed. - Supplemental Opioid Use — 0 to 72 hours post-dose
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
Countries
Australia, New Zealand