A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine; SABER-Placebo
Intervention description: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once; Injectable Solution; 5.0 mL SABER-Placebo/Once
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Postoperative pain; shoulder surgery; opioid

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.
    

Eligibility criteria:

        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.