evaluation of safety and efficacy of nalbuphine versus morphine for postoperative analgesia

Conditions: Postoperative Analgesia

Summary: evaluation of safety and efficacy of nalbuphine versus morphine patient controlled intravenous analgesia (pcia) for the treatment of postoperative analgesia


Eligibility criteria:
inclusion criteria: 1. age 18-65 years (inclusive), regardless of gender. 2. weight 45-100 kg (inclusive) and bmi 18.0-30.0 kg/m² (inclusive). 3. preoperative asa physical status class i-iii. 4. scheduled for elective general anesthesia in abdominal surgery (single incision ≥5 cm) or orthopedic surgery (limb/joint procedures); completed anesthesia recovery within 4 hours postoperatively, with nrs score ≥4, and willingness to accept protocol-defined analgesia. 5. ability to comprehend study objectives, operate pcia devices, and communicate effectively with investigators. 6. female subjects must be non-pregnant, non-lactating, and agree to use contraception (including partners) for 3 months post-study. 7. voluntary participation with signed informed consent. 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 \ 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.