Postoperative pain
Conditions
Interventions
Low dose group:Iv infusion of HR1405-01 40mg (6 hours/time)
High dose group:Iv infusion of HR1405-01 80mg (6 hours/time)
Placebo control group:Iv infusion of normal saline (6 hours/time)
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 informed consent; (2) 18 years old = age =75 years old, regardless of gender; (3) 18 kg/m^2=bmi=30 kg/m^2; (4) Elective orthopedic surgery under general anesthesia: unilateral joint replacement (such as unilateral hip replacement, unilateral knee replacement), unilateral ligament reconstruction (such as unilateral knee ligament reconstruction, unilateral rotator cuff repair), etc., the expected operation time was about 1-3 hours, and the expected postoperative pain was moderate to severe (NRS=4). (5) Subjects with american society of anesthesiologists (ASA) grade ?-III; (6) Expected PCIA =48 hours after surgery; (7) Able to understand the research process and use pain scales, operate the PCIA equipment, and communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: (1) known allergies to or contraindications to NSAIDs such as loxoprofen or other drugs that may be used during the trial; (2) long-term (continuous or intermittent) use of hormonal drugs, opioid analgesics, or other drugs used within the 5 half-lives before randomization (7 days before randomization if the half-lives are not clear) and judged by the investigator to affect the analgesic effect (according to the actual drug instructions); Including but not limited to NSAIDs, monoamine oxidase inhibitors, glucocorticoids (except aerosol inhalation and topical application of skin and mucosa), opioid analgesics, sedative drugs, antiepileptic drugs, antidepressant drugs, anticonvulsant drugs, anxiolytic drugs, Chinese patent medicine/plaster with analgesic effect, etc. (refer to the list of banned drugs for specific types); (3) the last use of potent anticoagulants such as aspirin, warfarin and clopidogrel was less than 5 days from the start of surgery; (4) Prior to randomization, patients 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; (5) history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; (6) subjects with malignant tumors with extensive metastasis; (7) subjects at 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 any clinically significant active bleeding (other than active bleeding due to the intended surgical focus), Or patients with active bleeding disease such as gastrointestinal ulcer or perforation within 6 months before randomization who were not suitable for participation in the trial according to the evaluation of the investigator; (8) patients with severe liver, kidney, cardiovascular and cerebrovascular diseases (such as coronary heart disease), or metabolic diseases judged by the investigators to be not suitable for the study; (9) subjects with central nervous system diseases such as cerebral ischemia, craniocerebral injury, or seizures, or with mental system diseases such as schizophrenia, mania, mental confusion, or major depression, which would affect the efficacy evaluation of the investigational drug according to the investigator's judgment; (10) combined with other pain or other physical pain conditions that may confound the evaluation of postoperative pain; (11) Poorly controlled subjects: sitting systolic blood pressure =160 mmHg and/or sitting diastolic blood pressure =100mmHg during screening; (12) abnormal laboratory test results in the screening period and clinical objection. 1) platelet count 470ms (QTcF was calculated using Fridericia's formula). (13) Syphilis antibody and human immunodeficiency virus (HIV) antibody were positive during the screening period. (14) patients who donated blood or lo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine consumption within 24h; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;The total amount of morphine consumed at 0-48h and 24-48h;PCIA morphine consumption at 0-24h, 0-48h, and 24-48h;Rescue morphine consumption during 0-24h, 0-48h, and 24-48h;The total number of PCIA compressions and the effective number of PCIA compressions within 24h and 48h were recorded;Area under the pain intensity-time curve for different time periods;Time to first pressing the analgesia pump for analgesia;Time to first use of rescue analgesic;Proportion of subjects requiring rescue analgesia within 24h and 48h;Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactSaiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed