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 herniorrhaphy.
Inclusion Criteria:
- Has body mass index (BMI) > 19 and < 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open mesh, tension free technique)
to be performed according to standard surgical technique under general anesthesia.
- Has a risk classification of I, II or III according to the ASA.
- Is free of other physical or mental conditions that, in the opinion of the
Investigator, may confound the quantification of postoperative pain after
herniorrhaphy.
- Has the ability and willingness to comply with the study procedures and the use of
the pain scales.
- Is willing to use only permitted medications and anesthetics throughout the study.
- Is willing to use opioid rescue analgesia for moderate to severe incisional pain
only.
- Must voluntarily sign and date an informed consent form (ICF) that is approved by an
Institutional Review Board (IRB) before 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 a known hypersensitivity to amide local anesthetics, opioids, bovine products or
inactive ingredients of the test article.
- Is scheduled for bilateral inguinal herniorrhaphy.
- Has undergone a prior herniorrhaphy on the side that is currently scheduled for
repair.
- Has cardiac arrhythmias 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
- 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 before Screening.
- Has undergone major surgery within 3 months of the scheduled herniorrhaphy.
- 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) before surgery.
Patients who, in the Investigator's opinion, are developing opioid tolerance are to
be excluded.
- Has impaired liver function, aspartate aminotransferase (AST)/alanine
aminotransferase (ALT)/bilirubin ≥ 3. 0 times the upper limit of normal (ULN),
active hepatic disease, evidence of clinically significant liver disease or another
condition (eg, alcoholism, cirrhosis or hepatitis) that may suggest the potential for
an increased susceptibility to hepatic toxicity with exposure to test article.
- Has any clinically significant unstable cardiac, neurological, immunological, renal
or hematological disease or any other condition that, in the opinion of the
Investigator, could compromise the patient's welfare, ability to communicate with the
study staff or otherwise contraindicate study participation.
- Is judged by the Investigator to be at risk for infection or slow wound healing.
- Has a chronic painful condition that might confound the assessment of pain associated
with the herniorrhaphy.
- Routinely uses pain medication that, in the opinion of the Investigator, could
confound the pain assessments during the study.
- Has been treated with agents that could affect the analgesic response (such as
central alpha agents, neuroleptic agents and other antipsychotic agents) within 2
weeks of surgery.
- Has been treated with monoamine oxidase inhibitors (MAOIs) within 10 days of surgery.
- Has been treated with systemic corticosteroids within 7 days of surgery (inhaled and
topical corticosteroids are allowed).
- Has participated in a clinical trial within 30 days of surgery.
