A Single-dose, Open-Label Pilot Study to Assess the Technique for Administering LNP in Herniorrhaphy Surgery

Inclusion Criteria:

1. Male subjects between 18-55 years of age who are scheduled to undergo herniorrhaphy surgery;
2. Subjects are within ±15% of ideal body weight/height (based on frame size) as given by the Metropolitan Life Insurance Tables;
3. Subjects are ASA Category I or II and in normal physical health (other than the need for the surgical procedure) as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;
4. Subjects must agree to refrain from ingesting any analgesic medication for 2 days or 5 half-lives of the drug prior to the study period;; refrain from using caffeine and alcohol on surgery day and during the study period; and use only the analgesic medication provided by the study team during the study period;
5. The subject is capable of reading, comprehending, and signing the informed consent form.

Exclusion Criteria:

1. Patients who have surgical complications such as excessive blood loss;
2. Subjects that are expected to use PCA to control the post-operative pain;
3. Subjects with a history of melena or any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;
4. Subjects with a history of any type of cancer;
5. Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions);
6. Subjects with any history of alcohol or substance abuse;
7. Subjects that currently have or have a history of uncontrolled hypertension;
8. Subjects with a known hypersensitivity to any local anesthetic drug;
9. Subjects with a hematocrit level below the normal range on the screening laboratory examination;
10. Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
11. Subjects with any condition or history felt by the Investigator to place the subject at increased risk;
12. Consumption of food or drinks containing alcohol, grapefruit, caffeine, or xanthine (e.g., coffee, tea, caffeinated soft drinks, chocolate, etc.) on surgery day. Such restricted items include coffee, tea, Coke® Pepsi®, Mountain Dew®, chocolate, etc;
13. Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
14. Subjects who have used an investigational drug within 30 days prior to entering the study;
15. Subjects who have donated blood within 3 months prior to the start of the study (including blood donation related to the surgical procedure);