Status:
RECRUITING
Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
Lead Sponsor:
Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
Conditions:
Postoperative Analgesia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia
Eligibility Criteria
Inclusion
- Age 18-65 years (inclusive), regardless of gender.
- Weight 45-100 kg (inclusive) and BMI 18.0-30.0 kg/m² (inclusive).
- Preoperative ASA Physical Status Class I-III.
- 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.
- Ability to comprehend study objectives, operate PCIA devices, and communicate effectively with investigators.
- Female subjects must be non-pregnant, non-lactating, and agree to use contraception (including partners) for 3 months post-study.
- Voluntary participation with signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06949852
Start Date
August 7 2024
End Date
March 1 2026
Last Update
April 29 2025
Active Locations (24)
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1
Peking University First Hospital
Beijing, China
2
Cangzhou People's Hospital
Cangzhou, China
3
The First People's Hospital of Changde City
Changde, China
4
The Third Xiangya Hospital of Central South Univerdity
Changsha, China