Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.
Brief Summary: The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.


Options:
A: Inclusion Criteria:

* Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both
* Able and willing to comply with all study visits and procedures.
* Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315.
* Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.
B: Inclusion Criteria:

1. Males 18 years of age and older at the Screening Visit.
2. Scheduled to undergo, elective, primary, unilateral, open-technique, tension-free (Lichtenstein-type technique with mesh) inguinal hernia repair under general anesthesia.
3. American Society of Anesthesiology (ASA) Physical Class 1-3.
4. Capable and willing to comply with all study visits and procedures and to provide written informed consent.
5. Able to speak, read, and understand the language of the informed consent form, 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.

Exclusion Criteria:

1. Use of any of the following medications within the times specified before surgery:

   * Long-acting opioid medication within 3 days.
   * Any opioid medication within 24 hours.
2. Concurrent painful physical condition that may require analgesic treatment in the postoperative period for pain that is not strictly related to the hernia repair procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, neuropathic pain, concomitant vasectomy).
3. Body weight less than 50 kilograms.
4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
5. Other contraindication to bupivacaine.
6. Contraindication(s) to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline 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.
7. Contraindication to any of the pain control agents anticipated to be used postoperatively (i.e., acetaminophen or oxycodone).
8. 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.
9. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
11. Current or historical evidence of any clinically significant condition that, in the opinion of the Investigator, may increase the risk of surgery, complicate the subject's postoperative course, or 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.

    If during surgery the following criterion is met:
12. Any clinically significant event or condition uncovered during the hernia repair surgery (e.g., excessive bleeding) that might render the subject medically unstable or complicate the subject's postoperative course.
C: Inclusion Criteria:

* Age ≥ 18 years at the Screening visit
* Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe
* Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours before surgery
* Clinical laboratory values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator
* Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments

Exclusion Criteria:

* Currently pregnant, nursing, or planning to become pregnant during the study or within one month after study drug administration
* Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
* Use of any non-steroidal anti-inflammatory drug (NSAID) including selective COX-2 inhibitor within three days of surgery
* Use of acetaminophen within 24 hours of surgery
* Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) within three days of surgery
* Current use of systemic glucocorticosteroids or use of systemic glucocorticoids within one month of enrollment into this study
* Peripheral neuropathy including diabetic neuropathy, chemotherapy-induced neuropathy, HIV neuropathy
* History of hepatitis
* History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
* Failure to pass urine drug screen
* Current evidence of alcohol abuse (greater than 4 units of alcohol per day: 1 unit = ½ pint of beer, 1 glass of wine or 1 oz. of spirits)
* Evidence of peripheral ischemic disease
* Type I or Type II diabetes
* Current acute or chronic medical or major psychiatric disease that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
* Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
* Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
* Previous participation in a SKY0402 study
* Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures
* Current painful physical conditions or concurrent surgery other than bunionectomy that may require analgesic treatment (such as NSAID or opioid) in the postoperative period for pain that is not strictly related to the bunionectomy procedure and may confound the postoperative assessments
D: Inclusion Criteria:

* Male or female, 18 years of age or older.
* Patients scheduled to undergo ileostomy reversal.
* Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing.
* Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Patients who have participated in an EXPAREL study within the last 30 days.
* Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

* Patients who have any concurrent surgical procedure.
* Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who receive Entereg(R).

Answer: B