Postoperative analgesia
Conditions
Interventions
Experimental Group:HYR-PB21 for injection, 200mg, was prepared in 20mL of 1% isotonic suspension with sterilized water for injection. A single dose was administered with multiple points of injection
Active Control group:Bupivacaine hydrochloride injection, 50mg, with 0.9% sodium chloride injection configured into 20mL 0.25% solution, single administration, multi-point injection.
placebo group:0.9% sodium chloride injection, 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 methods of pain intensity assessment, etc.), and voluntarily participated in the trial with full informed consent signed by the subjects themselves or their legal guardians; 2. When signing the informed consent, 18= 3.5cm. 5. Female or male subjects of childbearing age must agree to use effective contraceptive measures by themselves and their male subjects' partners within 30 days after signing the informed consent form
Exclusion criteria
Exclusion criteria: 1. Those who are allergic 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 who used other drugs that were judged by the investigators to affect the evaluation of analgesic efficacy (except those whose last use time was before 5 half-lives before randomization [according to the actual drug instructions, and 7 days before randomization if the half-lives were 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; Underwent contralateral hallux valgus osteotomy within 3 months before randomization; 4. 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, may confuse postoperative pain assessors; 7. Patients with any of the following clinically serious medical conditions or current serious medical conditions deemed by the investigator (physician) to affect the trial: (1) Respiratory diseases: such as severe pulmonary infection, acute exacerbation of bronchial asthma or a history of respiratory depression; (2) Neuropsychiatric diseases: such as craniocerebral injury, increased intracranial pressure, depression, anxiety, epilepsy (including a history of febrile convulsions in childhood), other brain diseases or mental state diseases that affect self-judgment ability; (3) patients with sensory loss of extremities or obvious peripheral neuropathy; (4) patients with 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 class III-IV patients) or clinically significant cardiac function or electrocardiographic abnormalities; (5) patients underwent coronary artery bypass grafting (CABG) within 12 months before screening; (6) Peripheral vascular diseases: such as arteriovenous thrombosis, arteriosclerosis obliterans, deep vein thrombosis, varicose vein disease and other peripheral vascular diseases; (7) known or suspected history of coagulopathy or loss of anticoagulant function, or known bleeding abnormalities; (8) patients with malignant tumors (except nonmetastatic 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; (9) 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. Laboratory results during the screening period meet the following criteria: (1) hemoglobin (Hb) = 3 times the upper limit of normal value and/or total bilirubin >= 2 times the upper limit of normal value; (4) Renal dysfunction: serum creatinine (Cr) >= 1.5 times of the upper limit of normal; (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain-time curve at rest (0-72 hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| The total amount of the rescue drug (calculated as the equivalent of intravenous morphine) was used within 0-XXh after the end of administration, of which xx = 24h, 48h and 72h;2. The proportion of subjects who did not use rescue drugs within 0-XXh after the end of dosing, where xx = 24h, 48h, and 72h;3. Time of first use of rescue medication after the subjects woke up;4. The total amount of rescue drugs used within 24h to 48h and 48h to 72h after the end of administration (calculated as intravenous morphine equivalent);(5) The area under the curve of pain intensity score during exercise (AUC0-xx), xx = 12h, 24h, 36h, 48h, 60h and 72h;;The area under the curve of pain intensity score at rest was AUC0-xx (xx = 12h, 24h, 36h, 48h and 60h). AUC24h-48h and AUC48h-72h;7. NRS score at each observation time point;8. The proportion of subjects with NRS score =1 at each observation time point;9. SPIS 0-xx, where xx = 12h, 24h, 36h, 48h, 60h and 72h; SPIS 24h-48h; SPIS 48h-72h;;10. On the 4th day after the end of drug administration, subjects' satisfaction with postoperative analgesia was evaluated; | — |
Countries
China
Contacts
Public ContactMingzhu Zhang/Guyan Wang
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed