Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair
Condition: Postoperative Pain
MeSH terms: Hernia; Hernia, Inguinal
Intervention: Bupivacaine HCl; SKY0402
Intervention description: Bupivacaine HCl given during hernia repair; SKY0402 given during hernia repair
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hernia; unilateral; postoperative; analgesia

Summary:

      The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of
      bupivacaine HCl.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males 18 years of age and older at the Screening Visit.

          2. Scheduled to undergo, elective, primary, unilateral, open-technique, tension-free
             (Lichtenstein-type technique with mesh) inguinal hernia repair under general
             anesthesia.

          3. American Society of Anesthesiology (ASA) Physical Class 1-3.

          4. Capable and willing to comply with all study visits and procedures and to provide
             written informed consent.

          5. Able to speak, read, and understand the language of the informed consent form, 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.

        Exclusion Criteria:

          1. Use of any of the following medications within the times specified before surgery:

               -  Long-acting opioid medication within 3 days.

               -  Any opioid medication within 24 hours.

          2. Concurrent painful physical condition that may require analgesic treatment in the
             postoperative period for pain that is not strictly related to the hernia repair
             procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis,
             neuropathic pain, concomitant vasectomy).

          3. Body weight less than 50 kilograms.

          4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.

          5. Other contraindication to bupivacaine.

          6. Contraindication(s) to epinephrine, such as concurrent administration of monoamine
             oxidase (MAO) inhibitors or antidepressants of amitriptyline or imipramine types,
             conditions where the production or exacerbation of tachycardia could prove fatal
             (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other
             pathological conditions that might be aggravated by the effects of epinephrine.

          7. Contraindication to any of the pain control agents anticipated to be used
             postoperatively (i.e., acetaminophen or oxycodone).

          8. Administration of an investigational product within 30 days or 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. 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.

         11. Current or historical evidence of any clinically significant condition that, in the
             opinion of the Investigator, may increase the risk of surgery, complicate the
             subject's postoperative course, or 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.

             If during surgery the following criterion is met:

         12. Any clinically significant event or condition uncovered during the hernia repair
             surgery (e.g., excessive bleeding) that might render the subject medically unstable or
             complicate the subject's postoperative course.