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 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster
Post-op Pain Relief System.
Inclusion Criteria:
- Must be a woman who is ≥ 18 and ≤ 75 years of age.
- Has a body mass index (BMI) > 19 and < 40 kg/m2.
- Has planned an elective total abdominal hysterectomy for reasons other than
malignancies (such as uterine adenocarcinoma, cervical cancer or leiomyosarcoma) to
be performed according to standard surgical technique using a standard incision and
under general anesthesia with the following caveats:
- Laparoscopic procedures or supraumbilical or Maylard incisions will not be
allowed.
- A nonlaparoscopic incision for benign nonhysterectomy gynecological procedures
(such as myomectomy or adnexal surgery) is acceptable if the surgical indication
is not to treat pelvic pain.
- No concomitant vaginal procedures such as anterior and posterior colporrhaphy
(A&P repairs) are allowed. An abdominal urethropexy and an incidental
appendectomy will be allowed.
- Has a risk classification of I, II or III according to the American Society of
Anesthesiologists (ASA).
- Is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and
nonlactating.
- Is free of other physical or mental conditions that, in the opinion of the
Investigator, may confound quantification of postoperative pain resulting from the
abdominal hysterectomy.
- Has the ability to read, understand and comply with the study procedures and the use
of the pain scales; is deemed capable of operating a patient controlled analgesia
(PCA) device; and is able to communicate meaningfully with the study staff.
- Must voluntarily sign and date an informed consent form (ICF), approved by an
Institutional Review Board (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, bovine products or to
inactive ingredients of the test article or reference product.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses other amide local anesthetics.
- 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 major surgery within 3 months of the scheduled hysterectomy.
- Requires the use of Seprafilm® or other absorbable adhesion barriers for the
scheduled hysterectomy.
- Requires any additional surgical procedures either related or unrelated to the
abdominal hysterectomy during the same hospitalization (except for the specific
allowed procedures noted in the Inclusion Criteria).
- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the
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.
- Has used opioids or tramadol on an extended daily basis (> 7 days) prior to surgery.
Patients who, in the Investigator's opinion, are developing opioid tolerance are to
be excluded.
