Postoperative pain
Conditions
Interventions
Placebo group:Saline was injected locally
Bupivacaine group:75mg bupivacaine was injected locally
LN016 group:LN016 was injected locally
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written informed consent, understand the procedure and content of the study, be able to communicate well with the researchers, and be willing to abide by the relevant regulations of the study; 2. The age of signing the informed consent form was 18-75 years old (including the cut-off value), both male and female; 3. Unilateral open inguinal hernia repair under general anesthesia was planned; 4. American Society of Anesthesiologists (ASA) grade ?-?; 5. Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (including the cut-off value), with a body weight of no less than 50 kg for male patients and no less than 45 kg for female patients; 6. Screening eligible patients (male or female) of childbearing potential had to consent to use a medically approved contraceptive during the study and for 3 months after the dose, and women of childbearing age had to have a negative human chorionic gonadotropin (HCG) test within 7 days before study entry and had to be nonlactating.
Exclusion criteria
Exclusion criteria: 1. Patients with one or more of the following cardiovascular present or/and past medical history: a) history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; b) abnormal QTcF (QTcF >=450 msec in men or >=470 msec in women; QTcF was calculated with the use of Fridericia's formula, QTcF=QT/[RR0.33], RR=60/HR, or obtained directly from the electrocardiogram) at screening that was judged by the investigator to be clinically significant; c) abnormal vital signs at screening that were judged by the investigators to be clinically significant, including pulse 100 beats /min; Uncontrolled hypertension: untreated systolic blood pressure (SBP) >=170 mmHg and/or diastolic blood pressure (DBP) >=105 mmHg; Or SBP>160 mmHg and/or DBP>100 mmHg after treatment with antihypertensive drugs; 2. Patients with one or more of the following hematological diseases or/and past medical history: a) patients with a high bleeding risk, including: patients with congenital bleeding disorders (e.g., hemophilia), patients with abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or patients with any clinically significant active bleeding; b) abnormal coagulation function and/or blood routine tests at screening that were judged by the investigators to be clinically significant, including prothrombin time (PT) > 3 seconds and/or activated partial thromboplastin time (APTT) > 10 seconds; White blood cell count =7.0 mmol/L and/or random blood glucose >=11.1 mmol/L and/or glycosylated hemoglobin >=6.5% at screening, and clinically significant according to the investigator's judgment; 6. Abnormal liver and kidney function at screening and clinically significant according to the investigator's judgment: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBIL) >=1.5×ULN; Total protein (TP) =1.5×ULN; 7. Persons with other medical histories that could significantly affect the trial: a) malignant tumors with extensive metastasis; b) patients with a history of ipsilateral inguinal hernia repair within 1 year before randomization; c) if another concurrent surgical procedure (e.g., bilateral inguinal hernia repair) is planned during the trial; d) combined with other pain or pain caused by other diseases that may confound postoperative pain assessment as j
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Pharmacokinetic parameters;NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first rescue analgesia;Proportion of rescue analgesia;Cumulative use of rescue analgesics;Participants' overall satisfaction with analgesia; | — |
Countries
China
Contacts
Public ContactKaiming Duan
The Third Xiangya Hospital of Central South University
Outcome results
None listed