Dose Finding Posterolateral Thoracotomy Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Low Dose SKY0402; High Dose SKY0402; Placebo; Fentanyl via PCA; Bupivacaine via epidural
Intervention description: Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal); Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal); Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal); Fentanyl via PCA; Bupivacaine via epidural
Intervention MeSH terms: Fentanyl; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; postoperative; thoracotomy

Summary:

      To review safety and effectiveness of two doses compared to current standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age at the Screening Visit.

          -  Scheduled to undergo a thoracotomy of at least 3 inches of intercostal incisional
             length or requiring insertion of an inter-rib spreader/retractor for a primary
             thoracic non-infectious indication under general anesthesia.

          -  Able and willing to receive an epidural catheter for the treatment of postoperative
             pain.

          -  American Society of Anesthesiology (ASA) Physical Class 1-4.

          -  Able and willing to comply with all study visits and procedures.

          -  Able to speak, read, and understand the language of the ICF, study questionnaires, and
             other instruments used for collecting subject-reported outcomes, in order to enable
             accurate and appropriate responses to pain scales and other required study
             assessments.

          -  Willing and capable of providing written informed consent.

        Exclusion Criteria:

          -  Known metastatic disease of any type.

          -  Known pulmonary infectious disease.

          -  Pregnancy, nursing, or planning to become pregnant during the study or within one
             month after study drug administration.

          -  Use of any of the following medications within the times specified before surgery:

               1. Long-acting opioids within 3 days.

               2. Any opioid medication within 24 hours.

          -  Concurrent painful physical condition or concurrent surgery that may require analgesic
             treatment in the postoperative period for pain that is not strictly related to the
             surgical site being administered study drug (e.g., significant pain from other joints,
             chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the
             potential to confound the postoperative study assessments.

          -  Body weight less than 50 kilograms (110 pounds).

          -  History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics,
             opioid medication, epinephrine, or sulfites.

          -  Contraindication to epinephrine, such as concurrent administration of ergot-type
             drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline or
             imipramine types, conditions where the production or exacerbation of tachycardia could
             prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any
             other pathological conditions that might be aggravated by the effects of epinephrine.

          -  Administration of an investigational product within 30 days or 5 elimination
             half-lives of such investigational product, whichever is longer, prior to study drug
             administration, or planned administration of another investigational product or
             procedure during the subject's participation in this study.

          -  History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          -  Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the Investigator, may interfere with study assessments or compliance with
             the protocol.

          -  Significant medical conditions or laboratory results that, in the opinion of the
             Investigator, indicate an increased vulnerability to study drugs and procedures, and
             expose the subject to an unreasonable risk as a result of participating in this
             clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial
             or complete conduction block, impaired cardiac function, untreated hypertension,
             advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing
             abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis),
             advanced liver disease, sever renal impairment, advanced diabetes, co-morbid
             conditions associated with an immunocompromised status, such as blood dyscrasias,
             HIV/AIDS, or recent chemotherapy.