Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
NCT ID: NCT06949852
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
288 participants
INTERVENTIONAL
2024-08-07
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nalbuphine group
Nalbuphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Morphine group
Morphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Interventions
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Nalbuphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Morphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, , China
Cangzhou People's Hospital
Cangzhou, , China
The First People's Hospital of Changde City
Changde, , China
The Third Xiangya Hospital of Central South Univerdity
Changsha, , China
Heping Hospital affiliated to Changzhi Medical College
Changzhi, , China
Chengdu Fifth People's Hospital
Chengdu, , China
Sichuan Provincial People's Hospital
Chengdu, , China
Chongqing University Affiliated Fuling Central Hospital
Chongqing, , China
Deyang People's Hospital
Deyang, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The First Affiliated Hospital of Jinan University
Guangzhou, , China
The First Affiliated Hospital Of University Of South China
Hengyang, , China
The Second Affiliated Hospital of Jiaxing University
Jiaxing, , China
The First People's Hospital of Lianyungang
Lianyungang, , China
Liuzhou Worker's Hospital
Liuzhou, , China
Mianyang Central Hospital
Mianyang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
The Second Nanning People's Hospital
Nanning, , China
Ningbo Medical Center LIHUILI Hospital
Ningbo, , China
Ningbo NO.2 Hospital
Ningbo, , China
Shanxi Bethune Hospital
Taiyuan, , China
The First Affiliated Hospital of Wannan Medical College
Wuhu, , China
Affiliated Hospital of Jiangnan University
Wuxi, , China
Xi'an Honghui Hospital
Xi'an, , China
Countries
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Facility Contacts
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Other Identifiers
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YZJ-NBF-YZ-2303
Identifier Type: -
Identifier Source: org_study_id
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