postoperative analgesia
Conditions
Interventions
Test group-Low dose:HYR-PB21 100mg, 20ml, was administered as a single dose and administered at multiple points
Test group-High dose:HYR-PB21 200mg, 20ml, was administered as a single dose and administered at multiple points
Control group:Bupivacaine hydrochloride injection 50mg, 20ml, single administration, multi-point injection
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects were able to understand the procedures and methods of this clinical trial (including the method of pain intensity assessment, etc.), and voluntarily participated in the clinical trial with full informed consent signed by the subjects themselves or their legal guardians. 2) When signing the informed consent, 18= age =75 years old, regardless of gender; 3) body weight =50kg for male subjects and =45kg for female subjects with body mass index (BMI) between 19.0 and 32.0kg/m^2 (including cut-off values); 4) subjects were classified as American Society of Anesthesiologists (ASA) grade ?-?; 5) Subjects planned to undergo unilateral hallux valgus osteotomy under general anesthesia with a medial incision, and the total length of the incision was expected to be =3.5cm. 6) Female or male subjects of childbearing age must agree to use effective contraceptive measures by themselves and their partners within 30 days after signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) those who are allergic to or have a history of spontaneous reactions to amide local anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.), opioids (such as morphine, oxycodone, etc.), or any component of the drugs used in this trial, or those who are allergic (such as allergic to two or more drugs, foods, or pollens); 2) subjects using other drugs that were judged by the investigators to affect the evaluation of analgesic efficacy (except for those whose last use was before 5 half-lives before randomization [based on the actual drug instructions, or 7 days before randomization if the half-life was unclear]); 3) subjects who had used Chinese patent medicine with analgesic effect within 7 days before randomization, which affected the postoperative pain evaluation according to the investigator's judgment; 4) patients underwent contralateral hallux valgus osteotomy within 3 months before surgery; 5) planned concurrent surgical procedures (e.g., bilateral hallux valgus osteotomy); 6) acute or chronic physical pain unrelated to unilateral hallux valgus osteotomy (e.g., rheumatoid arthritis, chronic neuropathic pain), or preexisting pain associated with surgery, anticipated need for postoperative pain management, which may confuse postoperative pain assessors; 7) Patients with a history or current serious medical condition of any of the following that would affect the trial as judged by the investigator (physician) : ? Respiratory diseases: such as severe pulmonary infection, acute exacerbation of bronchial asthma or a history of respiratory depression; ? Neuropsychiatric diseases: such as craniocerebral injury, increased intracranial pressure, depression, anxiety, epilepsy history (including a history of febrile convulsions in childhood), other brain diseases or mental state diseases that affect self-judgment; ? patients with sensory loss of limbs or obvious peripheral neuropathy; (4) a history of clinically significant cardiac abnormalities, such as unstable angina and/or myocardial infarction within the past 6 months, heart failure (New York Heart Association [NYHA] class ?-? patients) or clinically significant cardiac function or electrocardiogram abnormalities; ? history of coronary artery bypass grafting (CABG) within 12 months before screening; ? Peripheral vascular disease: such as arteriovenous thrombosis, arteriosclerosis obliterans, deep vein thrombosis, varicose vein disease and other peripheral vascular diseases; ? Known or suspected history of coagulopathy or loss of anticoagulant function, or known bleeding abnormalities; ? Malignant tumors (except metastatic basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 2 years before screening; ? known glucose-6-phosphate dehydrogenase deficiency; ? Patients with other foot diseases, deformities, trauma, other diseases or disease history that may significantly affect the safety evaluation or metabolism of the trial drug, and who were judged by the investigators to be not suitable for the trial. 8) If the screening laboratory test results meet the following criteria: ? Hemoglobin (Hb) =80g/L; ? Platelet count (PLT) =50×109/L; ? Abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 3 times the upper limit of normal value and/or total bilirubin = 2 times the upper limit of normal value; ? Renal dysfunction: serum creatinine (Cr) = 1.5 times the upper limit of normal value;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of pain rating score at rest (AUC0-72h); | — |
Secondary
| Measure | Time frame |
|---|---|
| The total amount of rescue drug used within 0-72 hours after the end of the dose (calculated as intravenous morphine equivalent);The proportion of subjects who did not use rescue drugs within 0-72 hours after the end of the dose;The time of first use of rescue drug after the subjects regained consciousness; | — |
Countries
China
Contacts
Public ContactMingzhu Zhang/Guyan Wang
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed