Postoperative pain
Conditions
Interventions
30mg Group:Meloxicam injection 30mg
60mg Group:Meloxicam injection 60mg
Placebo control group:Sodium chloride injection
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) fully understand and voluntarily participate in this study, and sign the informed consent; 2) elective abdominal surgery under general anesthesia; 3) subjects with ASA grade I or II; 4) aged from 18 to 70 years old (including the critical value), regardless of gender; 5) body mass index in the range of 18-30 kg/m2 (including the cutoff value); 6) understand the research process and the use of pain scales, and communicate effectively with researchers. 7) Postoperative conditions: a. Within 4 h after surgery (from the end of the last stitch), the NRS pain score of the subjects in the resting state was =4; b. Subject can answer questions and follow instructions and participate in necessary pain assessments as specified by the protocol; c. During and after the procedure, the subject did not develop any clinically significant symptoms or signs, as judged by the investigator, that would significantly increase the risk of the subject using the study drug; d. There was no occurrence of any event during the preoperative drug use, intraoperative surgical operation and intraoperative anesthesia that the investigators thought might increase the risk of the subjects participating in this study, affect the judgment of the study results, or possibly affect the subjects participating in this study.
Exclusion criteria
Exclusion criteria: 1) undergoing open or laparoscopic surgery within 1 year before randomization; 2) patients with active bleeding diseases such as gastrointestinal ulcer or perforation within 6 months before randomization, which may be worsened by NSAIDs and should not be considered suitable for the trial according to the investigator's assessment; 3) history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; 4) patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases should not participate in the trial according to the investigator's judgment; 5) combined with migraine, seizures and other mental diseases, which may affect the efficacy evaluation of the trial drug according to the investigator's judgment; 6) combined with chronic pain or other physical pain conditions that may confound the evaluation of postoperative pain; 7) subjects with advanced malignancy; 8) subjects who did not receive regular antihypertensive treatment or whose blood pressure was poorly controlled (SBP =160 mmHg or =90mmHg in sitting position at screening and/or DBP =100 mmHg or =60 mmHg at screening); 9) QTc during screening: male > 450 ms, female > 470 ms(QTc was calculated with Fridericia's formula); 10) poor glycemic control during screening: random blood glucose =11.1mmol/L; 11) abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)=1.5×ULN and/or total bilirubin (TBIL)=1.5×ULN; 12) abnormal renal function during screening: serum creatinine (Cr)=1.5 times upper limit of normal (ULN); 13) screening coagulation abnormalities: prothrombin time (PT) prolongation exceeding 3 seconds and/or activated partial thromboplastin time (APTT) prolongation exceeding 10 seconds; 14) abnormal platelet count during screening: platelet count < 50×109/L; 15) syphilis antibody and human immunodeficiency virus (HIV) antibody were positive during the screening period; 16) known allergies to or contraindications to meloxicam and NSAIDs such as vehicle, aspirin, and other drugs that may be used during the trial; 17) cancer subjects treated with chemoradiotherapy or other biologic therapies (within 60 days before the screening period or within 30 days after expected dose), long-acting NSAIDs such as meloxicam tablets (within 7 days or five half-lives before randomization; The longer), other NSAIDs (within 3 days before randomization or 5 half-lives, whichever is the longer); 18) using other drugs that affect analgesic effect before randomization, and the time interval between the last use of drugs and randomization is less than 5 half-lives (subject to the actual drug instructions), Including but not limited to monoamine oxidase inhibitors, glucocorticoids (intravenous), microsomal enzyme inducers, sedative drugs, analgesic drugs outside the test drug, antiepileptic drugs, antidepressant drugs, anticonvulsant drugs, anti-anxiety drugs, etc. (refer to the list of banned drugs for specific types); 19) subjects whose alcohol, drug, or drug withdrawal during the study may affect the efficacy and safety evaluation of the trial drug; 20) pregnant or lactating female subjects; 21) who planned to have children 30 days before randomization and were unwilling or unable to use effective contraception within 30 days after the end of the trial; 22) participating in a clinical study of another drug or device within 30 days before randomization (providing informed consent and recei
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Score Pain Intensity Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed