HSK16149 for Perioperative Analgesia in Orthopedic Surgery

Exclusion Criteria

• •1. Any of the following medical histories or conditions prior to screening:
• •* Long history of chronic pain;
• •* history of severe cardiovascular or respiratory disease;
• •* history of neurological or psychiatric disorders;
• •* history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system;
• •* major surgery within 3 months;
• •* patients with high bleeding risk;
• •* history of renal disease treated with dialysis within 28 days before surgery;
• •* have active infection within the past 2 weeks;
• •2. Use of any of the following medications or treatments:
• •* opioid analgesics for more than 10 consecutive days within 3 months prior to screening;
• •* other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label);
• •3. Abnormal laboratory tests during screening:
• •4. Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;
• •5. A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
• •6. Participated in another clinical trial and received IMP within 30 days prior to screening;
• •7. Pregnant or lactating women;
• •8. Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;