Postoperative pain
Conditions
Interventions
TRD303 low dose group:TRD303 solution (0.3+/-0.1mL/cm) was applied to the wound
TRD303 high-dose group:TRD303 solution (0.6+/-0.1mL/cm) was applied to the wound
Positive control group:Ropivacaine injection 100mg was administered by local infiltration
Placebo group:Local infiltration of 0.9% sodium chloride injection was administered
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent, and voluntarily abide by the process of this study; 2. 18 years old 50kg for male participants and >45kg for female participants; 4. American Society of Anesthesiologists (ASA) grade I-II; 5. Elective abdominal surgery under general anesthesia, including laparoscopic (at least one surgical incision =5cm) or open surgery; 6. Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to or contraindicated to ropivacaine or other amide local anesthetics, the inactive ingredients of the trial drug, or other drugs that may be used during the trial, and who are judged by the investigator to be unsuitable for the trial; 2. Use the following drugs for less than 5 half-lives before randomization (according to the actual drug instructions, the half-life is unknown, and the elution is according to 48 hours); Including but not limited to: class III antiarrhythmic drugs, glucocorticoids (intravenous), anticonvulsants, sedative and hypnotic drugs, anxiolytic drugs, antidepressant drugs, CYP1A2 enzyme inhibitor, sedative drugs (except those used according to the protocol), analgesic drugs (except those used according to the protocol), the specific types refer to the list of prohibited drugs; 3. successful use of Chinese herbal medicine with definite analgesic effect assessed by investigators from 7 days before signing ICF to randomization; 4. patients who underwent abdominal surgery within 1 year before randomization; 5. patients who planned to undergo surgery at other sites during the study period; 6. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator; 7. Patients with congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency; 8. Previous and/or family history of malignant hyperthermia; 9. Participants with poorly controlled blood pressure during screening (systolic blood pressure >=160 mmHg or =100 mmHg or 100 beats/min during screening (excluding abnormal heart rate during anesthesia), and the abnormal heart rate was judged by the investigator to be clinically significant; QTcF>450ms in men and >470ms in women [QTcF=QT/(RR^0.33)]; Or a history of severe arrhythmias such as atrioventricular conduction block of grade II or higher, or cardiac insufficiency; 11. Patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases were judged by the investigator to be ineligible for the trial; 12. Patients with advanced malignant tumors who were judged by the investigators to be not suitable for participating in the trial; 13. Patients with a history of mental diseases (such as schizophrenia, depression, etc.), dementia, migraine, or epilepsy, who were judged by the investigator to be unfit for the trial; 14. Patients with skin infection, ulceration or scar constitution around the incision, judged by the investigator to be not suitable for the trial; 15. Participants with a history of psychoactive and narcotic drug abuse, drug use, and heavy drinking (i.e., drinking an average of more than 2 units of alcohol per day (1 unit =360mL of beer or 45mL of 40% liquor or 150 ml of wine) in the year before randomization; Laboratory abnormalities: 16. Poor glycemic control during screening: random blood glucose >=11.1mmol/L or glycosylated hemoglobin >8%; 17. Abnormal liver function during screening :ALT and/or AST >=1.5 times upper limit of normal, or total bilirubin >=1.5 times upper limit of normal; 18. Abnormal renal function during screening: serum creatinine (Cr)=1.5 times upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Proportion of participants taking rescue analgesics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' overall satisfaction with analgesia was scored;Cumulative use of rescue analgesics;Cumulative number of rescue analgesics used;Drug plasma concentration; | — |
Countries
China
Contacts
Public ContactSaiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed