Study of Pain Control in Hemorrhoidectomy
Condition: Hemorrhoid
MeSH terms: Hemorrhoids
Intervention: SKY0402; Placebo
Intervention description: During the operation, 30cc of SKY0402 are injected into the wound.; During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemorrhoid; Hemorrhoidectomy; Postoperative pain; Analgesia

Summary:

      Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and
      their pain and pain medicine use will be monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years of age at the Screening visit

          -  American Society of Anesthesiologists (ASA) class 1-3

          -  Scheduled to have a two or three column excisional hemorrhoidectomy under general
             anesthesia using the Milligan-Morgan technique

          -  For female subjects, surgically sterile or at least two years menopausal, or using an
             acceptable method of birth control; must have a documented negative blood or urine
             pregnancy test within 24 hours before surgery

          -  Clinical lab values less than or equal to twice the upper limit of normal or, if
             abnormal, deemed not clinically significant per the Investigator.

          -  Ability to understand the requirements of the study, provide written informed consent,
             abide by the study restrictions, and agree to return for the required assessments

          -  Able to speak, read, and understand the language of all subject-facing documents,
             including the ICF and study questionnaires

          -  Able and willing to comply with all study visits and procedures

        Exclusion Criteria:

          -  Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component

          -  Body weight less than 50 kilograms (110 pounds)

          -  History of hypersensitivity or idiosyncratic reactions or amide-type local
             anesthetics, opioids, or propofol

          -  Current painful physical condition or concurrent surgery other than hemorrhoids that
             may require analgesic treatment (such as non-steroidal anti-inflammatory drug [NSAID],
             opioid, selective serotonin reuptake inhibitor [SSRI], tricyclic antidepressant,
             gabapentin, pregabalin) in the postoperative period for pain that is not strictly
             related to the hemorrhoidectomy procedure and may confound the postoperative
             assessments

          -  Concurrent fissurectomy

          -  Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic
             antidepressant, gabapentin, or pregabalin within three days of surgery

          -  Use of acetaminophen within 24 hours of surgery

          -  Chronic users of analgesic medications, including taking opioid medications for more
             than 14 days in the last 3 months, or non-opioid pain medications more than 5 times
             per week

          -  History of, suspected, or known addiction to or abuse of drugs or alcohol within the
             past two years

          -  Current use of glucocorticosteroids or use of glucocorticoids within one month of
             enrollment into this study

          -  HIV infection or hepatitis

          -  Currently pregnant, nursing, or planning to become pregnant during the course of the
             study or within one month of study drug administration

          -  Any psychiatric, psychological, medical, or laboratory condition that the investigator
             feels makes the subject an inappropriate candidate for this clinical trial

          -  Subjects who have received another investigational drug within the longer of the last
             30 days or 10 elimination half-lives

          -  Previous participation in a SKY0402 study

          -  Failure to pass drug and alcohol screen