An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Summary
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.
Timeline
- Start
- 2009-05
- Primary completion
- 2009-12
- Completion
- 2010-07
Outcome
Missed primary endpoint
registry analysis (superiority test); SABER-Bupivacaine vs SABER-placebo; p = 0.467; LS Mean Difference -0.21 (95% CI -0.79 to 0.36); t-test in ANOVA model NCT00993226 ↗
registry analysis (superiority test); SABER-Bupivacaine vs SABER-placebo; p = 0.331; LS Mean Difference -2.51 (95% CI -7.59 to 2.58); t-test in ANOVA model NCT00993226 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 5 ml | — |
| Subject | Bupivacaine | Other / unclassified | 7.5 ml | — |
| Subject | Bupivacaine | Other / unclassified | 40 ml | — |
Indications
No indication recorded.