osteoarthritis
Conditions
Interventions
Morphine hydrochloride injection group: load dose 4mg, PCA single pump dose 1mg.:Morphine hydrochloride injection
Oliceridine 1.5mg (0.35mg) dose group: load dose 1.5mg, PCA single pump dose 0.35mg:Oliceridine load dose 1.5mg, PCA single pump dose 0.35mg
Oliceridine 1.5mg (0.40mg) dose group: load dose 1.5mg, PCA single pump dose 0.40mg:Oliceridine load dose 1.5mg, PCA single pump dose 0.40mg
Oliceridine 1.5mg (0.50mg) dose group: load dose 1.5mg, PCA single pump dose 0.50mg:Oliceridine load dose 1.5mg, PCA single pump dose 0.50mg
Oliceridine 2.0mg (0.35mg) dose group: load dose 2.0mg, PCA single pump dose 0.35mg:Oliceridine load dose 2.0mg, PCA single pump dose 0.35mg
Sponsors
Liuzhou Worker's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent and comply with the test procedure; 2. Age =18 years old, male or female; 3. Body mass index (BMI) 18-28kg/m2 (including boundary values); 4. Subjects who plan to undergo unilateral total knee replacement or unilateral knee ligament reconstruction under general anesthesia; 5. American College of Anesthesiologists (ASA) Grade I-II; 6. Female subjects (not surgically sterilized, defined as having undergone hysterectomy or bilateral oophorectomy) had negative pregnancy test results during the screening period. Male and female subjects and their spouses/partners agree to have no pregnancy plans (including sperm and egg donation plans) and to voluntarily use effective contraception throughout the study period and for at least 1 month after medication; 7. NRS score =4 points in resting state within 4 hours after the operation (the last stitch was completed).
Exclusion criteria
Exclusion criteria: 1. A known history of allergy to any component of the investigational drug, or allergy or contraindication to the anesthetic/analgesic drugs used in the study; 2. Have the following diseases or history: a) A history of stroke, cognitive impairment, or a history of epilepsy (excluding previous convulsions caused by febrile convulsions in children); b) difficult airway (such as obstructive sleep apnea syndrome); Severe chronic obstructive pulmonary disease, bronchial asthma, pulmonary interstitial fibrosis and other respiratory diseases; c) Patients with myocardial infarction, angina pectoris, or severe arrhythmias such as grade II and above atrioventricular block within 6 months prior to screening, and a history of cardiac function grade II or above according to the New York Heart Association (NYHA); d) A history of vestibular dysfunction or motion sickness; e) Diabetes history and HBA1c =9% during the screening period; f) Patients with gastroesophageal reflux disease who the investigator determines may be at increased risk of vomiting; g) paralytic gastrointestinal obstruction; h) The presence of other acute or chronic pain conditions before surgery or other physical pain conditions complicating the evaluation of postoperative pain. 3. Drugs affecting postoperative analgesia were used before randomization: a) Continuous use of opioid analgesics for any reason for more than 10 days in the 3 months before randomization, or use of drugs that affect the analgesic effect before randomization, and the last use time since the randomization time is less than 5 half-lives (subject to the drug instructions, if the half-life is unknown, press Eluting as 48h), including but not limited to: Opioids, tramadol, ketamine, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, flurbiprofen, Celecoxib, meloxicam, diclofenac, ibuprofen, parecoxib sodium, etc.), a2 adrenergic receptor agonists (dexmedetomidine hydrochloride, clonidine, etc.), Glucocorticoid drugs (dexamethasone hydrochloride, hydrocortisone, methylprednisolone, etc., except for topical or local use of glucocorticoids), antiepileptic drugs (carbamazepine, sodium valproate, etc.), sedative drugs (diazepam, Esazolam, midazolam, Alprazolam, barbitone, phenobarbital and chloral hydrate, etc.); b) Chinese herbal medicines or proprietary Chinese medicines with main effects of analgesia, sedation and antiemesis (except for external use) were taken within 48 hours before randomization. 4. During the screening period, the systolic blood pressure was less than 90mmHg or more than 160mmHg, and the diastolic blood pressure was less than 60mmHg or more than 100mmHg; 5. Peripheral blood oxygen saturation (SpO2) 450ms for males and 460ms for females during the screening period (QTc was calculated by Fridericia formula); 7. During the screening period, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were >1.5 times the upper limit of normal, total bilirubin >1.5 times the upper limit of normal, and blood creatinine (Cr) >1.5 times the upper limit of normal; 8. Patients with abnormal coagulation function during the screening period (PT extension exceeding the upper limit of normal by 3 seconds and/or APTT extension exceeding the upper limit of normal by 10 seconds); The abnormalities were clinically significant. 9. Have a history of drug abuse or drug use before screening; 10. Lactating women; 11. Have taken any medication (exc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID48; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number and cumulative use of relief and analgesic drugs;Percentage of subjects not using relief analgesics;Time of first use of relief analgesics;Percentage of effective PCA compressions;Time of first evacuation;Number of respiratory depressions (fingertip oxygen saturation less than 90) and severity;Nausea and vomiting events;Subject satisfaction score ; | — |
Countries
China
Contacts
Public ContactYanzhuo Zhang
Liuzhou Worker's Hospital
Outcome results
None listed