Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Intervention: SKY0402; Bupivacaine HCl
Intervention description: Single dose of SKY0402 administered locally into the surgical wound.; Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative pain; Analgesia

Summary:

      The primary objective of this study was to determine the appropriate dose of SKY0402 for the
      management of postoperative pain following inguinal hernia repair. This study evaluated the
      safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine
      HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair.
      Study drug was administered by surgical wound infiltration at the end of the hernia repair
      procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males ≥18 years of age at the Screening visit.

          2. Scheduled to undergo unilateral inguinal hernia repair under general anesthesia, using
             an open, tension free procedure (e.g., Lichtenstein technique with or without mesh).

          3. American Society of Anesthesiology (ASA) Physical Class 1 or 2.

          4. Able and willing to comply with all study visits and procedures.

          5. Capable of speaking and understanding the local language sufficiently to provide
             responses to pain assessment scales.

          6. Willing and capable of providing written informed consent.

        Exclusion Criteria:

          1. Clinically significant electrocardiogram abnormalities at Screening or on Day 1 (pre
             administration).

          2. Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.

          3. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the Investigator, might have increased the risk of surgery or
             complicated the subject's postoperative course.

          4. Opioid medication usage during the 7 day period preceding the administration of study
             drug.

          5. Current medical conditions that could have required treatment with analgesic
             medications in the postoperative period for pain that was not surgically related
             (e.g., rheumatoid arthritis).

          6. Body mass index >30 kg/m^2

          7. Body weight <60 kg.

          8. History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic
             agents.

          9. History of hypersensitivity, idiosyncratic reactions, and other contraindications to
             the pain control agents (opioid or non-opioid) anticipated to be used postoperatively.
             These contraindications may have included: angioedema and bronchospastic reactivity to
             non steroidal anti inflammatory drug, peptic ulcer (active within the last three
             months), hepatic or renal insufficiency.

         10. Coagulation disorders or ongoing anticoagulation treatment.

         11. Administration of an investigational drug within 30 days or five half lives (of
             elimination), whichever was longer, prior to study drug administration.

         12. Suspected or known history of substance abuse and/or alcoholism.

         13. Clinically significant complications during the hernia repair surgery (e.g., excessive
             bleeding), which might have rendered the subject medically unstable or might have
             complicated the subject's postoperative course.