NCT06949852 Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
| NCT ID | NCT06949852 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd |
| Condition | Postoperative Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 288 participants in total. It began in 2024-08-07 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Frequently Asked Questions
Who can join the NCT06949852 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Postoperative Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06949852 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 288 participants.
Is NCT06949852 currently recruiting?
Yes, NCT06949852 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd to inquire about joining.
Where is the NCT06949852 trial being conducted?
This trial is being conducted at Beijing, China, Cangzhou, China, Changde, China, Changsha, China and 11 additional locations.
Who is sponsoring the NCT06949852 clinical trial?
NCT06949852 is sponsored by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd. The trial plans to enroll 288 participants.