EXPAREL for Minimally Invasive Supracervical Hysterectomies
Condition: Pain
Intervention: Saline Solution for Injection; Exparel
Intervention description: Injection of 20mL of 0.9%Normal Saline; Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: laparoscopy; supracervical hysterectomy; Multimodal pain management; bupivacaine liposome; Exparel

Summary:

      The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy
      postsurgical pain, which may result in less need for supplemental opioid pain medications,
      fewer opioid related adverse events, and a better recovery experience for patients, which may
      offer an economic benefit to health care systems.

      Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or
      traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to
      24 hours and reduces overall requests for break through (additional) analgesia with opioid
      consumption compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 35--75 years of age at the Screening Visit.

          2. Female subjects only.

          3. Scheduled to undergo minimally invasive (robotic-assisted or laparoscopic)
             supracervical hysterectomy, under general anesthesia.

          4. Clinical laboratory values less than twice the upper limit of normal or, if abnormal,
             deemed not clinically significant per the Investigator.

          5. Ability to provide informed consent, adhere to the study visit schedule and complete
             all study assessments and language specific questionnaires.

        Exclusion Criteria:

          1. Currently pregnant, nursing, or planning to become pregnant.

          2. Use of any of the following medications within the times specified before surgery: a.
             opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of
             surgery. b. Use of acetaminophen within 24 hours of surgery.

          3. Concurrent painful physical condition or concurrent surgery that may require analgesic
             treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin,
             pregabalin) in the postoperative period for pain that is not strictly related to the
             minimally invasive supracervical hysterectomy procedure and may confound the
             postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain.

          4. Chronic user 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.

          5. Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids
             within one month of enrollment into this study.

          6. History of hepatitis (other than hepatitis A).

          7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          8. Failure of presurgical drug and alcohol screen.

          9. History of hypersensitivity or idiosyncratic reactions to amide-type local
             anesthetics, opioids, or propofol.

         10. Administration of an investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during the subject's participation in this study.

        12. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion
        of the Investigator, may interfere with study assessments or compliance. 13. Significant
        medical conditions or laboratory results that, in the opinion of the Investigator indicate
        an increased vulnerability to study drug and procedures, and expose subjects to an
        unreasonable risk as a result of participating in this clinical trial. 14. 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. 15. An incision length greater than 3 cm.