Postoperative pain,Enolic acid non-steroidal anti-inflammatory drugs
Conditions
Interventions
experimental group:Intravenous injection of QP001 injection 30 mg
control group:Intravenous sodium chloride injection
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 research, and sign the informed consent; (2) Patients who elect to undergo the following operations under general anesthesia: unilateral joint replacement (such as unilateral hip replacement, unilateral knee replacement, unilateral shoulder replacement, etc.), unilateral ligament reconstruction (such as single Lateral knee ligament reconstruction, unilateral rotator cuff repair, etc.), etc., the expected operation time is about 1-3 hours; (3) Subjects classified as I-III by the American Society of Anesthesiologists (ASA); (4) 18 years old = age = 75 years old, gender is not limited; (5) 18 kg/m2=BMI=30 kg/m2; (6) PCIA treatment is expected to be required for =48 hours after surgery; (7) Be able to understand the research process and the use of pain scales, operate PCIA equipment, and communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: (1) Known allergies or contraindications to meloxicam, excipients, aspirin and other NSAIDs, and other drugs that may be used during the trial; (2) Receiving the following medications before randomization: drugs that were used within 5 half-lives before randomization (7 days before randomization if the half-life was unclear) and were judged to affect the analgesic effect by the researcher (according to the actual drug instructions), Including but not limited to NSAIDs, monoamine oxidase inhibitors, glucocorticoids (except aerosol inhalation), sedatives, antiepileptic drugs, antidepressants, anticonvulsants, antianxiety drugs, etc. (refer to Table 9 for specific types of prohibited drugs); (3) Prior to randomization, there was a history of surgery that interfered with the safety and efficacy evaluation of the study, and/or other surgical procedures were planned at the same time; (4) Patients with a history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; (5) Subjects with malignant tumors with extensive metastasis; (6) (6) Subjects with high bleeding risk, including congenital bleeding disorders (such as hemophilia), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function) or patients with clinical Any significant active bleeding (except active bleeding due to the expected surgical lesion), or active bleeding disease complicated with peptic ulcer, perforation, etc. within 6 months before randomization, may be aggravated by taking NSAIDs, Those who are not suitable to participate in the trial after evaluation by the investigator; (7) Subjects with cerebral ischemic disease, seizures and other central nervous system diseases, which were judged to affect the efficacy evaluation of experimental drugs; (8) Combined with other pain, other physical pain conditions that may confound postoperative pain evaluation as judged by the investigator (9) Subjects with poor blood pressure control: sitting systolic blood pressure =160 mmHg during screening period and/or sitting diastolic blood pressure =100mmHg during screening period and/or sitting systolic blood pressure 450ms, female > 470ms (QTc is calculated by Fridericia formula, QTcF = QT/(RR^0.33)); (11) During the screening period, syphilis antibody and human immunodeficiency virus (HIV) antibody tests were positive; (12) Those who donated blood or lost more than 400 mL of blood within 3 months before administration, or received blood transfusion or used blood products; (13) Female subjects who are pregnant or breastfeeding; fertile subjects who have a reprod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactWen Ouyang
Outcome results
None listed