Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery

Inclusion criteria

• 18 years old ≤ age ≤ 75 years old, gender is not limited.
• 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
• Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
• Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
• After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.

Exclusion criteria

• Previous surgery on the same site that may affect pain perception at the surgical site.
• Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
• Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
• Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
• Poorly controlled hypertension.
• Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
• Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
• Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.
• Women who are pregnant or breastfeeding (within 1 year after delivery).
• Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
• Any other condition considered unsuitable for participation by the investigator.