Clinical trial: A Trial of HR18034 in Inguinal Hernia Repair (NCT04551924)

Eligibility criteria:
Inclusion Criteria:

        Able and willing to provide a written informed consent 2、Male or female between 18 and 70
        years of age 3、Scheduled to undergo a primary, inguinal hernia repair with mesh, and be
        able to use the anesthesia regimen 4、Meet the body mass 5、Conform to the ASA Physical
        Status Classification

        Exclusion Criteria:

          1. Clinically significant abnormal clinical laboratory test value

          2. Subjects with poor blood pressure control after medication

          3. Subjects with atrioventricular block or cardiac insufficiency

          4. Subjects with a history of myocardial infarction or unstable angina pectoris

          5. Subjects with a history of ischemic stroke or transient ischemic attack

          6. Combination of other pain conditions that may affect postoperative pain assessment

          7. Allergic to a drug ingredient or component

          8. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but
             not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer

          9. History of alcohol abuse or prescription and/or illicit drug abuse within 1 years

         10. Subjects with special diets (including tobacco, grapefruit and caffeine)

         11. Positive results on the urine drug screen or alcohol breath test indicative of illicit
             drug or alcohol abuse.

         12. History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or
             hepatitis B.

         13. Use of any of the following medications within 14 days or as specified prior to the
             study surgical procedure:

         14. Have had an inguinal hernia repair in the last 3 months before the study surgical
             procedure or presents with bilateral or recurrent inguinal hernia, other hernia
             presentations, or hernias with a large scrotal component that would be difficult to
             reduce surgically

         15. Participated in clinical trials of other drugs (received experimental drugs)

         16. History or clinical manifestations of significant renal, hepatic, gastrointestinal,
             cardiovascular, metabolic, neurologic, psychiatric, or other condition.

         17. Pregnant or nursing women

         18. No birth control during the specified period of time

         19. The inestigators determined that other conditions were inappropriate for participation
             in this clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 49-year-old man comes to the office because of the bulging in his groin.  Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases.  His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair.

Patient description (patient's own words): I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair.

Does the patient match the trial criteria? 1