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A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair
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. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia. The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.
Details
| Lead sponsor | Durect |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 124 |
| Start date | 2007-01 |
| Completion | 2007-10 |
Conditions
- Postoperative Pain
- Hernia
- Surgery
Interventions
- SABER-Bupivacaine
- SABER-Bupivacaine
- SABER-Placebo
Primary outcomes
- Pain Intensity on Movement — 1 to 72 hours post-dose
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). 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. - Proportion (Percent) of Patients Using Supplemental Opioids — 0 to 14 days post-dose
Countries
Australia, New Zealand