Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SKY0402 + bupivacaine HCl; Mid-dose SKY0402 + bupivacaine HCl
Intervention description: Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket; Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Breast augmentation; Pain; Analgesia

Summary:

      The primary objective of this study was to demonstrate the superiority of SKY0402 over
      conventional, commercially-available bupivacaine HCl with respect to the duration of the
      analgesic effect achieved by a single local administration of the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who met all of the following criteria were eligible for inclusion in the study:

          1. Women, 18-40 years of age at the Screening Visit.

          2. Postmenopausal, surgically sterile, or willing to use an 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 drug 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, sub-muscular, augmentation mammoplasty under
             general anesthesia.

          4. American Society of Anesthesiology (ASA) Physical Class 1-3.

          5. Able and willing to comply with all study visits and procedures.

          6. Able to speak, read, and understand the language of the 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:

          -  Subjects were not eligible for the study if they met any of the following criteria:

               1. Pregnancy, nursing, or planning to become pregnant during the study or within one
                  month after study drug administration.

               2. Body weight less than 50 kilograms.

               3. History of hypersensitivity or idiosyncratic reaction to amide-type local
                  anesthetics or to opioid medication.

               4. Administration of an investigational product within 30 days or 5 elimination
                  half-lives of such investigational product, whichever was longer, prior to study
                  drug administration, or planned administration of another investigational product
                  or procedure during the subject's participation in this study.

               5. History of, suspected, or known addiction to or abuse of illicit drug(s),
                  prescription medicine(s), or alcohol within the past 2 years.

               6. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
                  opinion of the Investigator, may interfere with study assessments or compliance.

               7. Significant medical conditions or laboratory results that, in the opinion of the
                  Investigator, indicated an increased vulnerability to study drugs and procedures,
                  and exposed the subject to an unreasonable risk as a result of participating in
                  this clinical trial (e.g., severe hepatic insufficiency, hypotension, heart
                  block, or severely impaired cardiac function).

                  In addition, the subject was ineligible to receive study drug if she met the
                  following criterion during surgery:

               8. 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.