A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China

Inclusion Criteria:

• 18≤age≤65 years of age, gender is not limited;
• ASA grade I or II;
• 18 ≤ body mass index (BMI) ≤ 30 [BMI = weight (kg) / height 2 (m2)];
• Patients who intend to undergo laparotomy or laparoscopic total or subtotalhysterectomy (with or without salpingectomy and oophorectomy) under elective generalanesthesia;
• Expected hospital stay ≥48 hours after surgery；
• Expected to require more than 24 hours of PCIA (patient controlled intravenousanalgesia) treatment after surgery;
• Ability to understand research procedures and pain scales, operate PCIA devices, andcommunicate effectively with investigators;
• Agree to participate in the trial and voluntarily sign the informed consent form.

Exclusion Criteria:

• Except for the chronic pain caused by the target lesion of this operation, those whohave a history of chronic pain for more than 3 months or who are undergoing regularanalgesia for more than 3 months;
• Those who have used barbiturates within 20 days before surgery, those who used otheranalgesics, muscle relaxants or sedatives within 24 hours before operation (excludingthose required for this operation), or those who used long-acting non-steroidalanti-inflammatory drugs (NSAIDs) within 12 hours, or those who used short-actingnon-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours before operation.
• A person with high bleeding risk, and also including who with congenital bleedingdisorders (such as hemophilia), thrombocytopenia (PLT < 80 × 10 ∧ 9 / L), abnormalplatelet function (such as idiopathic thrombocytopenic purpura, disseminatedintravascular coagulation, congenital platelet dysfunction, etc.) or any clinicallysignificant active bleeding, coagulopathy;
• A person who received full-dose anticoagulant therapy, activated protein C orthrombolytic drugs within 6 hours before surgery (except for heparin subcutaneousinjection for preventive treatment);
• People with heart failure (NYHA grade III or IV), unstable angina pectoris, acutemyocardial infarction, and severe arrhythmia within 6 months before surgery
• Hypertensive patients who have not been satisfactorily controlled by blood pressure (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥105mmHg), orACEI/diuretics for ≥30 days, or hypotension (systolic blood pressure <90mmHg);
• People with pulmonary fibrosis bronchial asthma, pulmonary heart disease or otherserious respiratory diseases that are not the purpose of this treatment;
• Person with gastrointestinal ulcer and a history of gastrointestinal bleeding within 6months before operation and required medical treatment(prophylactic medication orundiagnosed persons are not excluded);
• Those with previous cerebral arteriovenous malformations, cerebral aneurysms, braintumors, or preoperative traumatic brain injury, intracranial surgery, history ofstroke;
• Patients with poor glycemic control of diabetes (random blood glucose > 11.1mmol / L);
• Patients with autoimmune diseases, connective tissue diseases, etc. who need long-termuse of adrenocortical hormone therapy;
• Abnormal liver and kidney function: ALT/AST> 2 times the upper limit of normal value,or creatinine> upper limit of normal value, or dialysis treatment within 28 daysbefore surgery;
• Known to be allergic to multiple drugs in the past, or allergic to the components ofthis drug, NSAIDs, opioids;
• Patients who are afflicted with narcotic drugs, drugs, or resistant to opioids;
• History of alcohol abuse within one year prior to screening
• Those who have participated in other clinical trials within 3 months before surgery;
• Investigators believe that it is not suitable for participating in this research.