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

Exclusion Criteria25

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