Postoperative analgesia
Conditions
Interventions
Test group (Low dose):HYR-PB21,100mg, 20mL for injection
Test group (High dose):HYR-PB21, 200mg, 20mL for injection
Control group:Bupivacaine hydrochloride injection, 100mg, 20mL
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Subjects are able to understand the procedures and methods of this clinical trial (including the method of pain intensity assessment), and after sufficient informed consent, voluntarily participate and sign the informed consent form by the subject himself/herself or his/her legal guardian; (2) At the time of signing the informed consent, 18 = age = 65 years old, and gender is not limited; (3) Body weight = 50 kg for men and = 45 kg for women, and body mass index (BMI) between 19.0 and 30.0 kg/m2 (including threshold values); (4) Subjects were class I-III according to the American Society of Anesthesiologists (ASA) classification criteria; (5) Patients scheduled for unilateral foot or ankle fracture incision and reduction internal fixation surgery under general anesthesia and for whom popliteal fossa approach sciatic nerve block for postoperative analgesia is indicated; (6) Female or male subjects of childbearing age must agree to use effective contraception by themselves or their partners from the time of signing the informed consent until 30 days after the administration of the drug.
Exclusion criteria
Exclusion criteria: (1) Multiple injuries, combined with other injuries that may affect the safety and effectiveness of the study evaluated by the investigators; (2) People who are allergic to or have a history of special reactions to amide local anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.), opioids, or any component of the drugs used in this trial, or who are allergic to two or more drugs, foods, or pollen; (3) Patients who have a history of any of the following clinical serious diseases or are currently suffering from serious diseases that are determined by the investigator (physician) to affect this study: ? Neuropsychiatric diseases: such as craniocerebral injury, elevated intracranial pressure, depression, anxiety, epilepsy history (including a history of febrile convulsions in childhood), other brain diseases or mental state diseases that affect self-evaluation ability; Peripheral neuropathy; (2) Respiratory diseases: combined with lung inflammation, or suffering from obstructive or restrictive lung disease; Circulatory diseases: such as pulmonary heart disease, unstable angina and/or myocardial infarction within the last 6 months, patients with heart failure (according to the New York Heart Association [NYHA] classification III - IV patients) or poorly controlled hypertension (systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg) after medication; A history of coronary artery bypass within 12 months; The presence of peripheral vascular disease; (4) Blood system diseases: bleeding diseases caused by coagulation factor defects or other coagulation index disorders; (5) Digestive system diseases: such as known bleeding of the digestive system, gastrointestinal obstruction or perforation, and other diseases that may cause danger to the gastrointestinal tract; Endocrine and metabolic system: poorly controlled diabetes (random blood glucose =11.1mmol/L); (7) Patients with a history of chronic pain (pain lasting more than three months outside the indications for this surgery, such as trauma, shingles, trigeminal neuralgia, etc.); The presence of other diseases or disease histories that may significantly affect the safety evaluation or metabolism of the investigational drug. (4) Laboratory test results during the screening period meet the following requirements: ? Platelet count (PLT) =50×109/L; ? Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 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. (5) 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 were determined by the investigator to affect this trial; Use drugs that cause prolonged QT/QTc intervals (QTcF intervals are calculated using the Fridericia formula); (6) Those who are positive in virological examination (hepatitis B E antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody) during the screening period; (7) Due to the needs of the treatment plan, the patient plans to use other analgesic drugs except those
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS (AUC 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 ContactWeifeng Yu
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed