Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia

Exclusion Criteria

• •1. Known or suspected allergy/hypersensitivity to any component of the investigational product, other opioids, or contraindicated drugs specified in the protocol .
• •2. Neurological/psychiatric disorders including:
• •1. Clinically significant neurological diseases (e.g., epilepsy, cognitive impairment) .
• •2. History of brain injury, increased intracranial pressure, or psychiatric disorders (e.g., schizophrenia, bipolar disorder, depression, anxiety) that may interfere with safety or study assessments as judged by the investigator .
• •3. Cardiovascular diseases/history:
• •1. Severe cardiovascular conditions (NYHA Class II or higher), myocardial infarction, angina, or severe arrhythmia within the past year .
• •2. Abnormal 12-lead ECG findings during screening (e.g., sinus bradycardia ≤55 bpm, ≥Grade II AV block) deemed unsuitable by the investigator .
• •3. Resting systolic blood pressure ≥160 mmHg or \<90 mmHg, diastolic ≥100 mmHg pre-surgery .
• •4. Intraoperative circulatory instability (e.g., hypotension, bradycardia) assessed as high-risk for trial continuation .
• •4. Respiratory disorders/history:
• •1. Bronchial asthma, high-risk respiratory depression conditions (e.g., severe COPD ≥GOLD 3, sleep apnea syndrome) .
• •2. Preoperative SpO2 \<93% (room air) or intraoperative respiratory depression/ventilatory dysfunction deemed unsafe .
• •5. Paralytic ileus, biliary/pancreatic diseases within 12 months before screening .
• •6. Major surgery within 3 months prior to screening.
• •7. Acute/chronic non-surgical pain interfering with postoperative pain assessment .
• •8. Preoperative anemia: Hemoglobin \<70 g/L or hematocrit \<25% .
• •9. High bleeding risk:
• •1. Congenital bleeding disorders (e.g., hemophilia) .
• •2. Platelet count \<0.75×LLN, PT \>ULN+3s, or APTT \>ULN+10s .
• •10. Organ dysfunction:
• •1. Albumin \<35 g/L (untreated) .
• •2. Liver/kidney function abnormalities: TBIL/ALT/AST/ALP ≥1.5×ULN ; Creatinine ≥1.5×ULN or clinically significant renal impairment; Recent dialysis (within 28 days) .
• •11. Random blood glucose ≥11.1 mmol/L during screening (preoperative) .
• •12. Participation in other clinical trials with active treatment within 3 months before surgery .
• •13. Other conditions deemed unsuitable by the investigator for safety or protocol compliance.