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

Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Analgesia

Treatments: Drug: Nalbuphine Hydrochloride Injection; Drug: Morphine Hydrochloride Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06949852

YZJ-NBF-YZ-2303

Details and patient eligibility

About

Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 <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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups

Nalbuphine group

Experimental group

Treatment:

Drug: Nalbuphine Hydrochloride Injection

Morphine group

Active Comparator group

Treatment:

Drug: Morphine Hydrochloride Injection