Postoperative pain in orthopedics
Conditions
Interventions
HL-1186 High-Dose Tablet Group:Oral
HL-1186 low-dose tablet group:Oral
Acetaminophen Oxycodone Group:Oral
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75, no gender restriction; 2. BMI between 18 kg/m² and 30 kg/m²; 3. Elective orthopedic surgery under general anesthesia (such as unilateral hip replacement or unilateral knee ligament reconstruction), with expected moderate to severe postoperative pain; 4. American Society of Anesthesiologists (ASA) classification I-II; 5. Able to understand the study procedures and use of scales, and communicate effectively with researchers; 6. Participants fully understand the purpose, nature, methods of the study, and potential adverse events, voluntarily participate, and sign informed consent; 7. Within 4 hours after surgery (counting from the completion of the last suture), participants who meet the following conditions as judged by the researchers can be randomized: (1) Fully awake (MOAA/S score of 5 for three consecutive times); (2) Resting NRS score >= 4; (3) Researchers assess that the participant can safely swallow the study medication.
Exclusion criteria
Exclusion criteria: 1. Previous surgery on the same site that the investigator has assessed as potentially affecting pain perception at the surgical site; 2. Sensory abnormalities or other pains that may affect postoperative pain assessment or scale assessment as assessed by the investigator; 3. Neuropsychiatric disorders that, as assessed by investigators, may affect postoperative pain or scale assessment, such as depression, anxiety, memory and cognitive impairments, severe sleep disorders, previous suicidal behavior, or suicidal tendencies; 4. Any history of gastrointestinal diseases assessed by investigators that may affect oral drug absorption; 5. QTcF during screening period: >=450 ms for males, >=470 ms for females (using Fridericia method corrected for QT interval formula), unstable angina, myocardial infarction, severe arrhythmias (such as third-degree atrioventricular block), NYHA cardiac function grading >= III, or recurrent asthma attacks, etc., which are deemed unsuitable for inclusion as assessed by the investigator; 6. Poor hypertension control, i.e., systolic pressure >160 mmHg and/or diastolic pressure >100 mmHg (except perioperative period); 7. Sleep apnea syndrome, or a difficult airway assessed by investigators; 8. Those at high risk of bleeding and, after investigator assessment, are deemed unsuitable for this trial, including: congenital bleeding disorders (such as hemophilia), platelet dysfunction (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction), active bleeding, etc.; 9. Known allergy to any component of the investigational intervention drug, allergy to anesthetics/analgesics/antiemetic drugs used perioperative (from anesthesia induction to completion of the entire surgical process), or a history of allergy to >= three substances; 10. Participants with motion sickness or a history of perioperative vomiting, and the investigator suspects postoperative nausea and vomiting; 11. The time since randomization of the contraindicated drug specified in the last use protocol is shorter than the 5-half-life of the drug (half-life unclear, elution is assumed to be 7 days), and investigators have assessed that this may affect the evaluation of the trial drug; 12. Preoperative abnormal laboratory test indicators: platelet count 2.5 × upper normal limit, total bilirubin (TBil) > 1.5 × upper normal range, estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2; 13. Positive for human immunodeficiency virus antibodies, Treponema pallidum antibody positive with TRUST unheated hemolysium test for toluidine pallidum red, hepatitis B virus surface antigen positive with HBV-DNA positivity, or hepatitis C virus antibody positive; 14. History of alcohol abuse within 2 years prior to screening (i.e., drinking more than 14 units of alcohol per week, 1 unit = 360 mL of 5% beer or 45 mL of 40% baijiu, or 150 mL of 12% alcohol) or drug abuse; 15. Women during pregnancy or breastfeeding (within one year after delivery); 16. Fertile trial participants who have plans for procreation/cryopreservation or sperm/egg donation within 6 months from signing the informed consent form to the last dose, or refusing to use effective contraception (complete abstinence, barrier method, contraceptives, intrauterine devices, or sterilization); 17. Those who have participated in ot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID; | — |
Countries
China
Contacts
Public ContactmengchangYang
Sichuan Provincial People's Hospital
Outcome results
None listed