Pain
Conditions
Interventions
Experimental group:40mg of HR1405-01 was injected intravenously
Positive control group:Flurbiprofen axetil 50mg was administered intravenously
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily participate in this study, and sign the informed consent; 2. For subjects undergoing elective hysterectomy under general anesthesia or other abdominal surgery (such as myomectomy, colectomy, etc.), the expected operation time is about 1-3 hours; 3. Subjects with American Society of Anesthesiologists (ASA) grade ?-II; 4, 18 years old <= age <= 75 years old, regardless of gender; 5, 18 kg/m^2<= BMI<= 30 kg/m^2; 6. Be able to understand the research process and the use of pain scales, and communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: 1. Known allergy or contraindication to NSAIDs; 2. At the time of screening, there were contraindications to morphine judged by the investigators to be not suitable for participation in the trial, including bronchial asthma, decompensation of pulmonary heart disease, hypothyroidism, cortical insufficiency, dysuria, and inflammatory bowel infarction; 3. Patients with active gastrointestinal ulcer/bleeding or recurrent ulcer/bleeding in the past; 4. Patients with other serious diseases of the liver, kidney, cardiovascular, cerebrovascular, respiratory system, or metabolic system at the time of screening, such as respiratory depression, severe liver insufficiency, shock, or malignant tumor with distant metastasis, judged by the investigator to be not suitable for participating in the trial; 5. Long-term (continuous or intermittent) use of hormonal drugs and opioid analgesics; Other drugs used within 5 half-lives before randomization (7 days before randomization if the half-lives are not clear) that affect the analgesic effect according to the investigator's judgment (according to the actual drug instructions), Including but not limited to NSAIDs, monoamine oxidase inhibitors, glucocorticoids (except atomized inhalation and topical application of skin and mucosa), opioid analgesics, sedative drugs, antiepileptic drugs, antidepressant drugs, anticonvulsants, anxiolytic drugs, local anesthetics, other drugs with analgesic effect (subject to the actual instructions), Chinese patent medicine, plaster, etc. 6. Use of fluoroquinolones (e.g., enoxacin, lomefloxacin, norfloxacin, plulifloxacin, ofloxacin, levofloxacin, ciprofloxacin, moxifloxacin, sitafloxacin, etc.) within 5 drug half-life before randomization (7 days before randomization if the half-life is not clear) or plan to use during the trial; 7. Prior to randomization, the investigator assessed that the patient had a history of surgery that interfered with the safety and efficacy evaluation of the study, and/or planned to undergo other surgical procedures at the same time; 8. History of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; 9. Patients with high bleeding risk, including congenital bleeding disorders (e.g., hemophilia), abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or clinically significant subjects with any high bleeding risk; 10, combined with cerebral ischemic disease, increased intracranial pressure, craniocerebral injury, seizures and other central nervous system diseases, or combined with schizophrenia, mania, mental confusion, severe depression and other mental system diseases (mild to moderate insomnia, anxiety, depression and other physical pain conditions judged by the researchers may confuse the evaluation of postoperative pain; 12. If blood pressure was poorly controlled, after drug treatment, the sitting systolic blood pressure during screening period was >= 160 mmHg, and/or the sitting diastolic blood pressure during screening period was >= 100mmHg; 13. Abnormal laboratory test results in the screening period and judged to be clinically significant: platelet count = 11.1mmol/L; Abnormal liver and renal function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >= 1.5×ULN, total bilirubin (TBIL) >= 1.5×ULN, creat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve of the pain intensity-time during 0-24h at rest; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under curve of the pain intensity-time during 0-24h during movement;Area under curve of the pain intensity-time during 24-48h and 0-48h at rest and during movement;The amount of rescue morphine used was 0-24h, 0-48h, and 24-48h after the end of the first dose;Pain intensity score (NRS) at each time point during rest and exercise;The proportion of subjects with pain intensity score (NRS) =3 at rest and exercise at each time point;The number of rescue analgesia within 24 h and 48 h after the end of the first dose;Time to first use of rescue analgesia;Subjects' overall satisfaction with analgesia was scored; | — |
Countries
China
Contacts
Public ContactSaiying Wang / Wen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed