None listed
Conditions
Interventions
Experimental group:LY096006 injection, postoperative local infiltration around the incision, injection volume of 30mL, administered once
Control group:Control drug injection, postoperative local infiltration around the incision, injection volume of 30mL, administration once
Placebo group:Placebo injection, postoperative local infiltration around the incision, injection volume of 30mL, administered once
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who fully understand the purpose and requirements of the trial, voluntarily participate and sign the informed consent form approved by the ethics committee; 2. At the time of screening, aged 18-70 years (including the boundary value), and the gender is not limited; 3. It is planned to use stapled suprahemorrhoidal circumcision (PPH) under general anesthesia, and perform hemorrhoidectomy for internal hemorrhoids or mixed hemorrhoids dominated by internal hemorrhoids; 4. American Society of Anesthesiologists (ASA) grades I-III; 5. When screening, male weight >= 50.0kg, female weight >= 45.0kg, and 18.0kg/m^2 <= body mass index (BMI) <= 28.0kg/m^2 (only applicable to Part A); 6. At the time of screening, women of childbearing age (eg, women who have not undergone surgical sterilization or who have been postmenopausal for less than 1 year) have a negative blood pregnancy test result. Male and female subjects of reproductive age agreed to use effective contraception throughout the study period and for at least 30 days after dosing.
Exclusion criteria
Exclusion criteria: 1. Those who plan to undergo other operations within 30 days before the operation to 30 days after the end of the trial; 2. Those with a history of anesthesia accident, or the need to use epidural analgesia, nerve block analgesia, local analgesia by continuous infusion of percutaneous catheter, or other pain conditions that may affect the assessment of pain after hemorrhoidectomy, or have a history of severe or refractory postoperative nausea or vomiting; 3. Patients with only a single hemorrhoidectomy; 4. Use any of the following medications within the prescribed time before surgery: (1) Within 24 hours before surgery, use any opioids and NSAIDs (except = 14 days before surgery and non-analgesic purposes); (4) Use of strong CYP1A2 inhibitors or substrates, strong CYP3A4 inhibitors or substrates, or other caine-type local anesthetics within 5 half-lives; 5. Patients with the following medical history within 6 months before the screening visit: acute coronary syndrome, coronary revascularization, congestive heart failure (New York Heart Association [NYHA] grade >= II), cerebrovascular accident (including transient ischemic attack), severe peripheral atherosclerotic disease, cardiovascular surgery, severe arrhythmia requiring medical treatment; 6. There is a history of QT prolongation, or QTc>450ms (male) or>460ms (female) assessed during the screening period, or atrioventricular block; 7. Hypertensive patients with poorly controlled blood pressure after drug treatment (systolic blood pressure >= 160mmHg, diastolic blood pressure >= 90mmHg after medication during the screening period); 8. Those with history of severe head trauma or surgery, history of intracranial hypertension or state of intracranial hypertension, cerebral arteriovenous malformation, cerebral aneurysm, history of central nervous system tumor or history of epilepsy (including a history of febrile convulsion in childhood); 9. Abnormal results of the following laboratory tests: hemoglobin (Hb) = 7.8mmol/L; or alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN); or total bilirubin (TBIL), blood urea/urea nitrogen (BUN), serum creatinine (Cre)>1.5xULN; or prothrombin time (PT) prolongation >= 3s, activated partial thromboplastin time (APTT) prolongation>10s; 10. Those who are known to have a history of allergies to any components of the investigational drug or similar drugs, or those with allergic constitution; 11. Lactating patients; 12. Smoking, alcoholic or drug abusers (Part A only): (1) Smoking is defined as: those who smoked >= 5 cigarettes per day on average within 3 months before screening; (2) Alcoholism is defined as: drinking more than 14 units of alcohol per week within 3 months before screening (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine); (3) Drug abuse is defined as a person wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under time curve of pain intensity at different time periods after the end of drug administration in resting state;Plasma concentrations of ropivacaine and free (non-protein-bound) ropivacaine were measured; | — |
Countries
China
Contacts
Public ContactChen Xiangdong
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed