Postoperative pain
Conditions
Interventions
Experimental group:HR18034 380mg local infiltration
Positive control group:Ropivacaine 75mg local infiltration
Placebo control group:0.9% sodium chloride injection local infiltration
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before the trial, understand the nature, significance, possible benefits, possible inconveniences and potential risks of the trial in detail. Be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent; 2. Patients with grade III-IV internal hemorrhoids or external hemorrhoids or mixed hemorrhoids are to undergo external dissection and internal ligation under subarachnoid anesthesia, and the expected total length of the incision is greater than or equal to 3cm; 3. Age >= 18 years old, gender is not limited; 4. 18 kg/m^2 <= BMI <= 28 kg/m^2; 5. American Society of Anesthesiologists (ASA) grades I to II; 6. female subjects of childbearing potential had a negative blood pregnancy test within 7 days before randomization and were not lactating. Women of childbearing potential had to consent to use highly effective contraception during the trial and for 6 months after the trial. Blood pregnancy tests before administration and during the study had to be negative and not in lactation. Male subjects whose partner was a woman of reproductive age had to agree to use highly effective contraception during and for 3 months after the trial. Sperm donation was not allowed during the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of myocardial infarction or unstable angina pectoris within 6 months before randomization, or a history of severe arrhythmia such as atrioventricular block of degree II and above, or a history of NYHA cardiac function class II and above ; 2. Subjects with a history of ischemic stroke or transient ischemic attack (TIA); 3. Subjects with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; 4. Combined with other physical pain that may affect postoperative pain assessment; 5. History of severe or refractory postoperative nausea or vomiting; persistent or recurrent nausea and/or vomiting caused by other causes, including but not limited to gastric pyloric obstruction, hypercalcemia or active peptic ulcer; 6. Combined with spinal cord lesions or spinal lesions; 7. Subjects with a history of hemorrhoidectomy; 8. Combined with fecal incontinence, perianal abscess, anal fissure, anorectal prolapse, portal hypertension with rectal varices, and inflammatory bowel disease; 9. Abnormal laboratory test results within 7 days before randomization: a) Fasting blood glucose (FPG) = 8.3mmol/L; b) Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBiL)=1.5×ULN; c) Abnormal renal function: Serum creatinine (Cr)=1.5×ULN, or dialysis subjects; d) Abnormal coagulation function: PT>normal value Upper limit + 3s and/or APTT > upper limit of normal value 10s; e) Platelet (PLT)100 beats/min during the screening period; 11. Subjects diagnosed with refractory hypertension before randomization; 12. During the screening period, any one of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), human immunodeficiency virus (HIV) antibody, and syphilis antibody is positive; 13. Known allergies or contraindications to ropivacaine or other amide local anesthetics and other drugs that may be used during the trial; 14. Use any one of the following drugs before randomization: a) Within 24h before randomization, use any opioids, NSAIDs (except aspirin <300mg/day), other local anesthetics; b) Within 3 days before randomization, intravenous or Oral metronidazole; c) Intravenous or oral corticosteroids within 14 days before randomization; d) Central alpha-adrenergic agonists (such as clonidine), anticonvulsants (such as carbamazepine, Pregabalin, gabapentin), antidepressants (such as tricyclics, selective 5-HT reuptake inhibitors); e) within 5 half-lives before randomization, use of drugs that affect liver metabolism: strong CYP1A2 inhibitors: such as Ciprofloxacin, enoxacin, fluvoxamine; CYP1A2 substrates: such as theophylline, imipramine; strong CYP3A4 inhibitors: such as voriconazole, ketoconazole, ritonavir; CYP3A4 substrates: Ruda Lunavir, indinavir, saquinavir; strong CYP3A4 inducers: such as rifampicin; 15. History of drug abuse, drug use, and/or alcoholism within 1 year prior to randomization, defined as drinking more than 2 units of alcohol on average per day (1 unit = 360mL of beer or 45mL of liquor with 40% alcohol content or 150mL of wine); or consuming alcoholic foods or beverages within 24 hours before receiving the study drug; 16. Special diets (including tobacco, grapefruit, caffeine-containing, xanthine-rich foods/beverages) and/or excessive daily consumption of tea and c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Relief Score;Analgesia Satisfaction Evaluation;Sleepiness scores;Electrocardiogram (ECG);Heart rate, pulse;blood pressure;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed