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Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
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 (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.
Details
| Lead sponsor | Durect |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 331 |
| Start date | 2009-12 |
| Completion | 2011-09 |
Conditions
- Postoperative Pain
- Abdominal Surgery
Interventions
- SABER-Bupivacaine
- Bupivacaine HCl
- SABER-Placebo
Primary outcomes
- Mean Pain Intensity on Movement — 0 to 72 hours post-dose
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude. - Supplemental Opioid Use — 0-72 hours post dose
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Countries
United States, Australia, New Zealand