Hernia
Conditions
Interventions
Test group 1:H889A:1.6 mL
Test group 2:H889A:3.2 mL
Test group 3:H889A:4.8 mL
Test group 4:H889A:6.5 mL
Control group 1:H889AV:6.5mL
Control group 2:Bupivacaine hydrochloride injection: 75 mg+ Celecoxib capsules: 200 mg
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects can understand the procedures and methods of the clinical trial (including pain intensity assessment methods), and voluntarily participate in the clinical trial with the informed consent signed by the subjects themselves or their legal guardians after full informed consent; 2. When the informed consent is signed, the age of the subject is greater than or equal to 18 years old and the gender is not limited; 3. Weight =50kg for men and =45kg for women, with a body mass index (BMI) between 19.0 and 30.0kg/m 2 (including a critical value); 4. Subjects were graded I-III according to the American College of Anesthesiologists (ASA) criteria; 5. Patients scheduled for hernia surgery (including but not limited to inguinal hernia and incisional hernia); 6. Female or male subjects of childbearing age shall agree to use effective contraceptive methods for themselves and male subjects' partners within 30 days after signing informed consent to the medication.
Exclusion criteria
Exclusion criteria: 1. People who are allergic to or have a history of specific reactions to amide local anesthetics (such as lidocaine, bupivacaine, tetracaine and ropivacaine), opiates or any component of the drugs used in this study, or who are allergic to two or more drugs, foods or pollens; 2. Have a history of ipsilateral inguinal hernia repair or plan concurrent surgery (such as bilateral inguinal hernia repair); 3. Medical conditions unrelated to inguinal hernia repair (e.g., rheumatoid arthritis, chronic neuropathic pain, concomitant vasectomy) or pain associated with surgery may confuse the postoperative pain evaluator; 4. Those who have a history of or are currently suffering from any of the following clinical serious diseases: (1) Respiratory diseases: such as acute or bronchial asthma, pulmonary heart disease, other chronic lung diseases, or a history of respiratory depression; (2) Neuropsychiatric diseases: such as craniocerebral injury, elevated intracranial pressure, history of depression, anxiety, epilepsy (including a history of febrile convulsions in childhood), and other brain diseases or mental state diseases that affect the ability to self-evaluate; (3) Circulatory diseases such as unstable angina and/or myocardial infarction within the last 6 months, patients with heart failure (Class IIY-IV according to the New York Heart Association [NYHA] classification) or poorly controlled hypertension (systolic blood pressure =160mmHg or diastolic blood pressure =90mmHg); (4) Blood system diseases: hemorrhagic diseases caused by coagulation factor defects or other coagulation index disorders; (5) digestive system diseases: such as known gastrointestinal bleeding, gastrointestinal obstruction or perforation, and other gastrointestinal irritation may cause dangerous diseases; (6) The presence of other diseases or disease histories that may significantly affect the safety evaluation or metabolism of the tested drug in vivo. 5. Those whose laboratory examination results during the screening period meet the following requirements: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2 times the upper limit of normal value; (2) Serum creatinine (Cr) = 1.5 times the upper limit of normal value; (3) Prothrombin time (PT) > upper limit of normal +3s or activated partial prothrombin kinase time (APTT) > upper limit of normal +10s; 6. The QTcF interval was significantly prolonged (for example, the QTcF interval was > 450ms for the first examination during the screening period, and the value of three consecutive examinations was > 450ms, or the mean value of three examinations was > 450ms); The presence of other risk factors for TdP (e.g., heart failure, hypokalemia, bradycardia, hereditary long QT syndrome); Also use drugs that cause prolonged QT/QTc interval; 7. Positive results from pre-screening or screening virological tests (quantification of hepatitis B surface antigen, antibody to hepatitis C, antibody to human immunodeficiency virus antigen, antibody test to treponema pallidum); 8. People who have used analgesic drugs in the 24 hours prior to administration or have not had more than 5 half-lives since the last use of analgesic drugs (e.g. local anesthetics, NSaids, diclofenac or pregabalin, etc.) 9. Patients who cannot quit smoking or drinking alcohol (except for therapeutic drugs containing alcohol) from 48 hours before the operation to 72 hours after the end of medication; 10. Use of opioids or opioids in th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Key examination of surgical incision site;Pharmacokinetics;validity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory examination;routine 12-leads electrocardiogram;Vital signs;Physical examination; | — |
Countries
China
Contacts
Public Contactpingfei fang
The Second Xiangya Hospital of Central South University
Outcome results
None listed