Postoperative analgesia
Conditions
Interventions
Arm A:HYB-PB21 for injection 150mg, 30ml
Arm B:HYB-PB21 for injection, 300mg 30ml
Positive control group:Bupivacaine hydrochloride injection 75mg 30ml
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subject will be able to understand the procedures and methods of this clinical trial (including pain intensity assessment methods), voluntarily participate with full informed consent and be signed by the subject or legal guardian; 2. 18 to 75 years on the day of signing the informed consent form,no gender limit; 3. Male body weight >= 50kg, female body weight >= 45kg, and body mass index (BMI) between 19.0~30.0kg/m2 (including critical value); 4. Subjects are rated Level I-III by the American Society of Anesthesiologists (ASA); 5. It is planned to adopt stapler upper hemorrhoid circumference (PPH) under general anesthesia to perform hemorrhoidectomy for patients with internal or mixed hemorrhoids, mainly internal or mixed hemorrhoids, with cumulative incision length >=3cm. 6. The female or male subject of childbearing age shall agree to use effective contraceptive methods for herself and the male subject's partner within 30 days after signing informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy or history of allergic reaction to amide local anesthetics (such as lidocaine, bupivacaine, tetracaine and ropivacaine), opioids or any component of the drugs used in this study, or allergic constitution (such as allergy to two or more drugs, food or pollen); 2. Patients with hemorrhoidectomy alone or without hemorrhoidectomy; 3. Physical conditions unrelated to hemorrhoidectomy (e.g., rheumatoid arthritis, chronic neuropathic pain, associated vasectomy) or pain associated with surgery may confuse the postoperative pain evaluator; 4. Have a history or present history of any of the following serious clinical 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, increased intracranial pressure, history of depression, anxiety, epilepsy (including history of high fever convulsion in childhood), other brain diseases or mental state diseases that affect the ability of self-evaluation; (3) Circulatory diseases: unstable angina and/or myocardial infarction in the last 6 months, patients with heart failure (grade III-IV according to New York Heart Association [NYHA] classification) or patients with poor hypertension control (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 90mmHg); (4) Diseases of the blood system: bleeding diseases caused by coagulation factor defects or other coagulation indicators disorders; (5) Diseases of the digestive system: such as known gastrointestinal bleeding, gastrointestinal obstruction or perforation, and other diseases that may be caused by gastrointestinal irritation; (6) There are other diseases or a history of diseases that may significantly affect the safety evaluation or metabolism of the test drug. 5. If the results of laboratory examination during screening meet the following requirements: White blood cell (WBC) count exceeds the normal range; Hemoglobin (HGB) is beyond the normal range; Platelet count (PLT) exceeds the normal range; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2 times of the upper limit of normal value; Blood creatinine (Cr) >= 1.5 times of the upper limit of normal value; 6 creatinine clearance 7.8mmol/L; The upper limit of normal value of prothrombin time (PT)> +3s or the upper limit of normal value of partially activated thrombin time (APTT) > +10s; 6. Significantly extended QTcF interval (e.g., the screening period was first checked for QTcF interval > 450ms, and the test value was > 450ms for three consecutive times, or the mean > 450ms for three times);Presence of other risk factors for TdP (such as heart failure, hypokalemia, bradycardia, and inherited long QT syndrome); At the same time, drugs causing QT/QTc prolongation were applied. 7. Virology tests (hepatitis B E antigen, hepatitis C virus antibody, treponema pallidus antibody or human immunodeficiency virus antibody) before or during screening are positive; 8. Any analgesics (such as non-steroidal anti-inflammatory drugs, oxycodone, ketorolac, ketoprofen, diclofenac or pregabalin) that may be used or planned to be used within 12 hours before or during the operation; 9. Fails to give up smoking or alcohol (except for treatment drugs containing alcohol) between 48 hours before the operation and 72 hours after th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting pain score; | — |
Countries
China
Contacts
Public ContactZhengjun Wang
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed