Postoperative pai
Conditions
Interventions
YZJT-1705 injection 225mg group:225mg of YZJT-1705 was injected by local infiltration
YZJT-1705 injection 450mg group:450mg of YZJT-1705 was injected by local infiltration
YZJT-1705 injection 562.5mg group:562.5mg of YZJT-1705 was injected by local infiltration
YZJT-1705 injection 675mg group:675mg of YZJT-1705 was injected by local infiltration
Positive control:Local injection of hydrochloric acid, pp paid 50 to 100 mg
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age of 18-70 years old, including cut-off values, regardless of gender; 2) subjects scheduled for elective abdominal surgery under general anesthesia (including gastric, ileocecal, ascending colon, transverse colon, descending colon, sigmoid colon surgery and Dixon surgery, etc.), and the length of the surface surgical incision was 5cm-12cm (including the values of both ends, and excluding the incision length such as drainage tube); 3) American Society of Anesthesiologists (ASA)(Appendix 1) grade I-III; 4) Body weight: male =50kg, female =45kg, and 18.0kg/m2<BMI<30.0kg/m2; 5) subjects (including their partners) voluntarily took appropriate contraceptive measures from the time of signing the informed consent until 3 months after drug administration and had no plans of sperm donation (male subjects) or egg donation/egg freezing (female subjects); 6) the participants understand the purpose of this test and test steps, understand pain intensity evaluation methods, volunteered for the experiment, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1) those who are allergic to or have a history of spontaneous reactions to amide local anesthetics (e.g., lidocaine, bupivacaine, ropivacaine, etc.), opioids, or any component of the drugs used in this trial, or those who have an allergic constitution (e.g., allergic to two or more drugs, foods, or pollens); 2) previous intracranial malignant tumors; Or patients with craniocerebral injury and increased intracranial pressure within 6 months before screening; 3) patients who planned to undergo palliative tumor resection or exploratory surgery alone; Or screening period widely metastasis patients with late malignant tumor; 4) before/now suffer from migraine headaches, anxiety, seizures, cognitive dysfunction and diabetic peripheral neuropathic pain or after herpes zoster pain spirit, nervous system disease; And/or physical illness with acute or other acute onset of chronic pain within 3 months before randomization that the investigator believes may affect postoperative pain assessment; 5) have difficult airway disease, or obstructive sleep apnea syndrome, severe bronchial asthma, or other serious respiratory system diseases; 6) patients with previous diagnosis of porphyria, glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia; 7) have the following history of cardiovascular disease or: A) serious diseases of the cardiovascular system, NYHA heart function classification (appendix 3) class II or higher, always happened within 12 months after the myocardial infarction, angina, or coronary artery bypass grafting (CABG), atrioventricular block II degree or more serious heart rhythm disorders, Or the ECG was abnormal before entering the operating room and the investigator thought it was not suitable to participate in the study; b) patients with poorly controlled blood pressure (systolic blood pressure =160mmHg, and/or diastolic blood pressure =100mmHg in sitting or lying position at rest or in non-stress/tension state after signing informed consent until entering the operating room); C) after signing of the informed consent to the former (to) before anesthesia induction into the operating room check heart rate/pulse 1.5× upper limit of positive normal value (U L N), total bilirubin (T B I L)>1.5× U L N, prothrombin time (P T)> U L N before admission to the operating room + 3 s, activated clotting time (APTT) live enzymes to prolong 10 s, creatinine (Cr), acuity 1.5 x ULN, or other significantly increased risk of subjects according to the researcher's judgement of laboratory abnormalities; Electrocardiogram (ecg) before 10) into the operating room: male QTcF > 450 ms, women QTcF > 470 ms (QTc with Fridericia and type calculation: QTcF = QT/(RR ^ 0.33)); 11) blood glucose =11.1mmol/L before entering the operating room; 12) random before using the following drugs and within 5 half-lives are still (scheme used in narcotic drugs and preoperative to cooperate with the use of analgesic, sedative drugs except), "These include acetaminophen, NSAIDs (including combination preparations containing NSA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessments OF Safety;Researchers satisfaction score;Pharmacokinetics;Pharmacodynamics; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Remedial analgesic drugs in proportion of the subjects, average frequency and cumulative dose;;Time to first use of rescue medication;Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed