A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery

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.

Inclusion Criteria:

• Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff.
• Males and females, 18 to 65 years of age, scheduled for shoulder surgery.
• Patients must be healthy or have only mild systemic disease.
• Patients must have ECG wave form within normal limits
• Patients must have blood pressure within normal range.
• Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
• Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.

Exclusion Criteria:

• Patients with previous arthroscopic surgery or open surgery on the study shoulder.
• Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
• Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
• Patients with a below normal calculated creatinine clearance.
• Patients who are pregnant or lactating.
• Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
• Patients, who in the Investigator's opinion, have developed opioid tolerance.
• Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
• Patients with current or regular use of drugs known to significantly prolong the corrected QT interval
• Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
• Patients with known hypersensitivity to opioids.
• Patients with conditions contraindicated for use of opioids.
• Patients with known or suspected abuse of opioids or other illicit drugs.
• Patients with known or suspected alcohol abuse.
• Participation in another clinical trial at the same time or within 30 days of this trial.
• Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.