Postoperative pain,Enolic acid non-steroidal anti-inflammatory drugs
Conditions
Interventions
Experimental group:Intravenous administration of QP001 injection
Control group:Intravenous administration of sodium chloride injection
Sponsors
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Fully understand and voluntarily participate in this research, and sign the informed consent; (2) Patients who elect to have a total hysterectomy under general anesthesia (surgical incision length is not limited), or other abdominal surgery (such as myomectomy, colectomy, etc.) with expected single incision length greater than or equal to 3 cm under general anesthesia, the expected operation time is about 1-3 hours; (3) Subjects classified as I-II by the American Society of Anesthesiologists (ASA); (4) 18 years old = age = 65 years old, gender is not limited; (5) 18 kg/m2=BMI=30 kg/m2; (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 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 10 for specific types of prohibited drugs); Cancer subjects who had received chemoradiotherapy, hyperthermic perfusion, or other biologic therapy within 60 days before randomization or were scheduled to receive treatment during this study; (3) Patients who had undergone open or laparoscopic surgery and/or with a history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; (4) 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; (5) Subjects with cerebral ischemic disease, seizures and other central nervous system diseases, which were judged to affect the efficacy evaluation of experimental drugs; (6) Combined with other pain, other physical pain conditions that may confound postoperative pain evaluation as judged by the investigator (7) 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)); (9) During the screening period, syphilis antibody and human immunodeficiency virus (HIV) antibody tests were positive; (10 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; (11) Female subjects who are pregnant or breastfeeding; fertile subjects who have a reproductive plan during the trial a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity time curve at rest after awakening from anesthesia: AUC0-24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the pain intensity time curve at different time intervals after awakening from anesthesia in a resting state: AUC18-24, AUC24-48, AUC0-48, AUC42-48;Total morphine consumption;Remedial morphine dosage;Time of first use of remedial analgesics;Proportion of subjects who need remedial analgesia;Remedial analgesia frequency;Overall satisfaction score of subjects with analgesia; | — |
Countries
China
Contacts
Public ContactWeifeng Yu
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed