Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine Collagen Sponge (CollaRx®); placebo
Intervention description: The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.; The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
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: 54.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Post Operative Pain; Hysterectomy

Summary:

      The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and
      effective in reducing the amount of narcotic pain medication needed to control pain during
      the first 24 hours after abdominal hysterectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) > 19 and < 40 kg/m2

          -  Had planned an elective total abdominal hysterectomy for reasons other than
             malignancies to be performed according to standard surgical technique using a standard
             incision and under general anesthesia with the following caveats:

               1. Laparoscopic procedures or supraumbilical or Maylard incisions will not be
                  allowed

               2. A nonlaparoscopic incision for benign non-hysterectomy gynecological procedures
                  (such as myomectomy or adnexal surgery) is acceptable if the surgical indication
                  is not to treat pelvic pain

               3. No concomitant vaginal procedures are allowed. An abdominal urethropexy and an
                  incidental appendectomy will be allowed

          -  Have a risk classification of I, II or III according to the American Society of
             Anesthesiologists (ASA)

          -  Have a negative pregnancy test

          -  Be free of other physical or mental conditions which may confound assessment of
             postoperative pain

          -  Have the ability to read, understand and comply with the study procedures and the use
             of the pain scales; is capable of operating a patient-controlled analgesia (PCA)
             device; and is able to communicate meaningfully with the study staff

          -  Voluntarily sign and date an informed consent form (ICF), prior to the conduct of any
             study-specific procedures

          -  Able to fluently speak and understand English and be able to provide meaningful
             written informed consent for the study

        Exclusion Criteria:

          -  Known hypersensitivity to any active or inactive ingredient of the test articles

          -  Presence of clinically significant cardiac arrhythmias or atrioventricular (AV)
             conduction disorders

          -  Concomitant use of other amide local anesthetics

          -  Concomitant use of antiarrhythmics

          -  Concomitant use of propanolol

          -  Concomitant use of strong/moderate CYP3A4 inhibitors or inducers

          -  Has used aspirin or aspirin-containing products within 7 days of surgery.

          -  Previous major surgery in the last 3 months

          -  Requires any additional surgical procedures during the same hospitalization (except as
             noted)

          -  Received neuraxial (spinal or epidural) opioid analgesics either prior to or during
             surgery

          -  Received local anesthetic infiltration of the surgical wound prior to, during or
             immediately after closure

          -  Is scheduled to receive local anesthetics via an indwelling catheter after surgery

          -  Underwent additional procedures during surgery, which may increase the visceral pain

          -  Has known or suspected history of alcohol or drug abuse or misuse or evidence for
             tolerance or physical dependency on opioids analgesics or sedative-hypnotic
             medications

          -  Uses opioids or tramadol daily for > 7 days prior to test article administration

          -  Has impaired liver function

          -  Has any clinically significant unstable condition that could compromise the patient's
             welfare

          -  Is at risk for infection or slow wound healing

          -  Has a chronic painful condition that might confound the assessment of pain associated
             with the sugery

          -  Has taken pain medication that could confound the analgesic responses the day of
             surgery

          -  Has been treated within 2 weeks of surgery with agents that could affect the analgesic
             response

          -  Has been treated with monoamine oxidase inhibitors (MAOIs) or MAOIs have been stopped
             fewer than 10 days prior to surgery

          -  Has been treated with corticosteroids or whose treatment with these has been stopped <
             7 days prior surgery (inhaled corticosteroids are acceptable)

          -  Has participated in a clinical trial in the previous 30 days

          -  Has been hemodynamically unstable at any point in the previous 4 weeks or becomes
             hemodynamically unstable during surgery

          -  Required blood transfusion in the previous month, except as related to uterine
             bleeding caused by uterine fibroids.

          -  Has hemoglobin levels < 10 g/dL or < 8 g/dL for patients with an anemia secondary to
             heavy uterine bleeding caused by uterine fibroids.

          -  Has platelet count < 100,000/mm

          -  Unreliable or incapable of complying with the protocol