Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Intervention: Bupivacaine HCl; SKY0402
Intervention description: 100 mg Bupivacaine HCl; Single administration 300 mg SKY0402 in a 40-mL injection volume
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: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemorrhoids

Summary:

      Effective postoperative pain control to promote improved healing, faster patient
      mobilization, shortened hospital stays, and reduced healthcare costs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female equal or greater than 18 years of age at Screening

          -  Female subjects: postmenopausal, surgically sterile, or willing to use acceptable
             means of contraception for at least 30 days after surgery, nonheterosexual lifestyle,
             or strictly monogamous relationship with a partner who has had a vasectomy.

          -  Scheduled to undergo 2-or3-column excisional hemorrhoidectomy

          -  American Society of Anesthesiology (ASA) Physical Class 1-4

          -  Able and willing to complete with all study visits and procedures

          -  Able to speak, read, and understand the language of all study forms and instruments
             used for collecting subject-reported outcomes to provide accurate study assessments

          -  Willing and capable of provide written informed consent.

        Exclusion Criteria:

          -  Pregnant, nursing or planning to become pregnant during the study period

          -  Use of any long-acting opioid medication within 3 days of surgery or any opioid
             medication with 24 hours of surgery.

          -  Concurrent painful physical condition or concurrent surgery that may require analgesic
             treatment in the postoperative period for pain not strictly related to the procedure
             or that may interfere with study assessments.

          -  Single-column hemorrhoidectomy

          -  Body weight less than 50 kg (110 pounds)

          -  History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics,
             opioid medication, or any ingredient of the medications administered in this study
             (e.g., sulfites in Marcaine with epinephrine)

          -  contraindication to epinephrine

          -  contraindication to any of the pain-control agents planned for postoperative use

          -  Administration of an investigational drug within 30 days or 5 elimination half-lives
             of such investigational drug prior to study drug administration

          -  History of, known addiction, or abuse of illicit drugs, prescription medicines or
             alcohol within the past 2 years.

          -  Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere
             with study assessments or compliance.

          -  Significant medical conditions or laboratory results that 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.

          -  Any clinically significant event or condition uncovered during surgery

          -  A cumulative incision length less than 3 cm