Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
Condition: Postoperative Pain; Inguinal Hernia
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Intervention: Bupivacaine Collagen Sponge; placebo collagen sponge
Intervention description: collagen; Bupivacaine hydrocholoride; collagen
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: 53.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herniorrhaphy; Inguinal Hernia Repair; Postoperative pain

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 herniorrhaphy.
    

Eligibility criteria:

        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.