Conditions: Postoperative Pain
Keywords: Postoperative pain shoulder surgery opioid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
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.

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.

Detailed description:

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

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

Protocol document: