Conditions: Postoperative Pain Hernia Surgery
Keywords: Post-operative pain hernia surgery opioid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 2.5 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Bupivacaine/Once arm 3: 2.5 mL or 5.0 mL SABER-Placebo/Once

Interventions: intervention 1: SABER-Bupivacaine intervention 2: SABER-Bupivacaine intervention 3: SABER-Placebo
Intervention descriptions: intervention 1: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once intervention 2: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 3: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Protocol document: