Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine Collagen Sponge; Placebo
Intervention description: placebo
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastrointestinal surgery; Post operative pain

Summary:

      The purpose of this study is to determine whether the CollaRx Bupivacaine Implant
      (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication
      needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a man or woman who is ≥ 18 and ≤ 75 years of age.

          -  Has a body mass index (BMI) > 19 and < 40 kg/m2.

          -  Has a planned elective surgery that requires a vertical or transverse abdominal
             incision (including but not limited to abdominal aortic aneurysm repair,
             cholecystectomy and simple bowel resection) to be performed according to standard
             surgical technique under general anesthesia.

          -  Has a risk classification of I, II or III according to the American Society of
             Anesthesiologists (ASA)

          -  If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before
             surgery) and nonlactating.

          -  If female, is either not of childbearing potential or practicing a defined medically
             acceptable method of birth control and agrees to continue with the regimen throughout
             the study.

          -  Is free of other physical or mental conditions that, in the opinion of the
             Investigator, may confound quantification of postoperative pain resulting from the
             surgery.

          -  Has the ability and willingness to comply with the study procedures and the use of the
             pain scales; is deemed capable of operating a PCA device; and is able to communicate
             meaningfully with the study staff.

          -  Must voluntarily sign and date an informed consent form (ICF) that is approved by an
             IRB prior to the conduct of any study specific procedures.

          -  Must be able to fluently speak and understand English and be able to provide
             meaningful written informed consent for the study.

        Exclusion Criteria:

          -  Has known hypersensitivity to amide local anesthetics, opioids or bovine products, or
             to inactive ingredients of the test article.

          -  Has 1 of the following surgical procedures planned: total abdominal hysterectomy,
             omentectomy or surgical procedure for staging cancer.

          -  Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI
             surgery.

        Requires any additional surgical procedures either related or unrelated to the GI surgery
        during the same hospitalization.

          -  Is required to receive neuraxial (spinal or epidural) opioid analgesics during the
             study.

          -  Has cardiac arrhythmia or atrioventricular (AV) conduction disorders.

          -  Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate
             cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and
             grapefruit juice).

          -  Has used long acting analgesics within 24 hours of surgery. Short acting analgesics
             such as acetaminophen may be used on the day of surgery but are subject to
             preoperative restrictions for oral intake.

          -  Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a
             dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on
             a stable dose regimen for ≥ 30 days prior to Screening.

          -  Has undergone another major surgery within 3 months of the GI surgery.

          -  Has known or suspected history of alcohol or drug abuse or misuse within 3 years of
             Screening or evidence of tolerance or physical dependency on opioid analgesics or
             sedative hypnotic medications.