Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
Condition: Pain
Intervention: SKY0402; Bupivacaine HCl
Intervention description: 600mg SKY0402 instilled into breast pocket during surgery; 200mg Bupivacaine HCl instilled into breast pocket during surgery
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 136.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postsurgical pain; Analgesia; Breast augmentation

Summary:

      The purpose of this study is to provide a more effective postoperative method of pain control
      for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative
      pain management contributes to faster patient mobilization, shortened hospital stays, and
      reduced healthcare costs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women greater than or equal to 18 years of age at Screening Visit

          2. Postmenopausal, surgically sterile, or willing to use acceptable means of
             contraception for at least 30 days after surgery including any of the following:
             hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days
             before study administration), effective double-barrier methods (e.g., condoms with
             spermicide), intrauterine device, lifestyle with a personal choice of abstinence,
             nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who
             has had a vasectomy.

          3. Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation
             under general anesthesia (endotracheal or otherwise)

          4. American Society of Anesthesiologist (ASA) Physical Class 1-4

          5. Able and willing to comply with all study visits and procedures, and with diary
             entries through postoperative day 8

          6. Able to speak, read, and understand the language of the informed consent form (ICF),
             study questionnaires, and other instruments used for collecting subject-reported
             outcomes, in order to enable accurate and appropriate responses to pain scales and
             other required study assessments

          7. Willing and capable of providing written informed consent.

        Exclusion Criteria:

        A subject will not be eligible for the study if she meets any of the following criteria:

          1. Women undergoing reconstructive surgery following mastectomy

          2. Pregnancy, nursing, or planning to become pregnant during the study or within one
             month after study drug administration.

          3. Use of any of the following medications within the times specified before surgery:

               1. long-acting opioids within 3 days.

               2. Any opioid medication within 24 hours.

          4. Concurrent painful physical condition or concurrent surgery that may require analgesic
             treatment in the postoperative period for pain that is not strictly related to the
             surgical site being administered study drug (e.g., significant pain from other joints,
             chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the
             potential to confound the postoperative study assessments.

          5. Body weight less than 50 kilograms (110 pounds)

          6. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics,
             opioid medication, epinephrine, or sulfites.

          7. Contraindication to epinephrine, such as concurrent administration of ergot-type
             drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline or
             imipramine types, conditions where the production or exacerbation of tachycardia could
             provide fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease) or any
             other pathological conditions that might be aggravated by the effect of epinephrine.

          8. Administration of investigational product within 30 days of 5 elimination half-lives
             of such investigational product, whichever is longer, prior to study drug
             administration or planned administration of another investigational product or
             procedure during the subject's participation in this study.

          9. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

         10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance with
             the protocol.

         11. Significant medical conditions or laboratory results that, in the opinion of the
             Investigator, indicate an increased vulnerability to study drugs and procedures, and
             expose the subject to an unreasonable risk as a result of participating in this
             clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial
             or complete conduction block, impaired cardiac function, untreated hypertension,
             advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing
             abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis),
             advanced liver disease, severe renal impairment, advanced diabetes, co-morbid
             conditions associated with an immunocompromised status such as blood dyscrasias,
             HIV/AIDS, or recent chemotherapy.

             In addition, the subject will be ineligible to receive study drug if she meets the
             following criteria during surgery:

         12. Any clinically significant event or condition uncovered during the surgery (e.g.,
             excessive bleeding, acute sepsis) that might render the subject medically unstable or
             complicate the subject's postoperative course.