Patients undergoing unilateral total knee replacement surgery
Conditions
Interventions
Sentry Group:HYR-PB21 for injection 400mg, 60ml, single dose
Test group - Low dose:HYR-PB21 for injection 300mg, 60ml, single dose
Test group - High dose:HYR-PB21 for injection 400mg, 60ml, single dose
Control group:Bupivacaine hydrochloride injection, 150mg, 60ml, single dose
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subject can understand the procedures and methods of the clinical trial (including the pain intensity assessment method), and voluntarily participate in the trial after full informed consent and signed by the subject; (2) When signing the informed consent, age = 18 years old =75 years old, gender is not limited; (3) Male weight =50kg, female weight =45kg, and body mass index (BMI) between 19.0 and 30.0kg/m2 (including the cut-off value); (4) Subjects were classified as class I-III according to the American College of Anesthesiologists (ASA) grading standards; (5) Patients planning unilateral total knee replacement surgery under general anesthesia; (6) Female or male subjects of reproductive age must agree to use effective contraception by themselves or their partners for 30 days from the date of signing the informed consent.
Exclusion criteria
Exclusion criteria: (1) People who are allergic to or have a history of special reactions to any component of amide local anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.), opioids or the drugs used in this trial (such as acetaminophen), or people who are allergic to two or more drugs, foods, or pollen; (2) Other significant physical pain assessed by the investigator that may affect the evaluation of postoperative pain (such as significant pain in other joints, including non-affected knee joint, chronic neuropathic pain, contemporaneous or prior contralateral knee replacement, contemporaneous foot surgery, etc.); Other medical conditions that may affect the evaluation of safety and efficacy after administration; (3) Patients diagnosed with knee lesions caused by systemic diseases who plan to undergo unilateral total knee arthroplasty (TKA); (4) Patients with a history of respiratory system, nervous system, circulatory system, blood system, digestive system and systemic diseases who were judged by researchers (physicians) not suitable for inclusion in this study; (5) Laboratory test results during the screening period meet the following requirements: ? Platelet count (PLT) =50×109/L; (2) Glutalanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 1.5 times the upper limit of normal value; ? Serum creatinine (Cr) = 2 times the upper limit of normal value; ? Prothrombin time (PT) > upper normal value +3s or partially activated thrombin time (APTT) > upper normal value +10s. (6) The QTcF interval was significantly prolonged (for example, the QTcF interval was > 450ms for the first check during the screening period, and the value of three consecutive checks was > 450ms, or the average value of three checks was > 450ms); The presence of other risk factors for TdP (e.g., heart failure, hypokalemia, bradycardia, hereditary long QT syndrome) that the investigators determined affected the study; Or use of drugs that cause prolonged QT/QTc interval within 1 month prior to screening (QTcF interval calculation using the Fridericia formula); (7) Those who have a positive virological test (hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody) during the screening period; (8) Due to the needs of the treatment plan, the patient plans to use other analgesic drugs except those permitted under this plan within 72 hours after administration; (9) The use of analgesic drugs before the operation (except that the stoppage time has reached 7 drug half-lives (with a well-defined half-life) or more than 7 days (without a well-defined drug half-life); ; (10) Have used or are using aspirin, anticonvulsants, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, antipsychotics, serotonin, norepinephrine reuptake inhibitors, muscle relaxants, anticholinergics, and long-term use of hormone medications (except for local inhalation) prior to surgery (have reached 7 drug half-lives) A specified half-life) or more than 7 days (unless the drug half-life is not specified); Use no more than 100mg of aspirin daily prior to screening, unless discontinued for 3 days); (11) Those who cannot quit smoking or drinking alcohol (except for therapeutic drugs containing alcohol) from 48 hours before surgery to 72 hours after the end of administration; (12) Regular drinkers in the 3 months (90 days) prior to dosing, that is, those who drink more than 14 units of alcohol per week (1 unit =360mL beer or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC NRS-R, 0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Within 0-72h after the end of administration, the total amount of remedial drugs used (calculated according to intravenous morphine equivalent);Proportion of subjects who did not use remedial drugs within 0-72 hours after the end of administration;The time of first use of remedial drugs after the subject wakes up; | — |
Countries
China
Contacts
Public ContactHui Xu
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed