Actively Recruiting
Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
Led by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd · Updated on 2025-04-29
288
Participants Needed
24
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia
CONDITIONS
Official Title
Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years (inclusive), any gender
- Weight between 45 and 100 kg and BMI between 18.0 and 30.0 kg/m²
- Preoperative ASA Physical Status Class I to III
- Scheduled for elective abdominal surgery with single incision ≥5 cm or orthopedic limb/joint surgery
- Completed anesthesia recovery within 4 hours after surgery with pain score ≥4 and willing to accept study analgesia
- Able to understand study goals, operate PCIA devices, and communicate with study staff
- Female participants must not be pregnant or breastfeeding and agree to use contraception for 3 months after the study
- Voluntary participation with signed informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to study drugs, opioids, or contraindicated medications
- Significant neurological or psychiatric disorders including epilepsy, cognitive impairment, brain injury, increased intracranial pressure, schizophrenia, bipolar disorder, depression, or anxiety affecting safety or assessments
- Severe cardiovascular diseases (NYHA Class II or higher), recent myocardial infarction or angina, severe arrhythmia within past year, or abnormal ECG findings deemed unsuitable
- Resting systolic blood pressure ≥160 mmHg or <90 mmHg, diastolic ≥100 mmHg before surgery
- Intraoperative circulatory instability considered high risk
- Respiratory disorders such as bronchial asthma, severe COPD (GOLD 3 or higher), sleep apnea, or unsafe respiratory depression
- Paralytic ileus or biliary/pancreatic diseases within 12 months prior to screening
- Major surgery within 3 months before screening
- Acute or chronic non-surgical pain interfering with postoperative pain assessment
- Preoperative anemia with hemoglobin <70 g/L or hematocrit <25%
- High bleeding risk including congenital bleeding disorders, low platelet count, or abnormal clotting times
- Untreated low albumin (<35 g/L) or significant liver/kidney dysfunction or recent dialysis
- Random blood glucose ≥11.1 mmol/L at screening
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Peking University First Hospital
Beijing, China
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2
Cangzhou People's Hospital
Cangzhou, China
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3
The First People's Hospital of Changde City
Changde, China
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4
The Third Xiangya Hospital of Central South Univerdity
Changsha, China
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5
Heping Hospital affiliated to Changzhi Medical College
Changzhi, China
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6
Chengdu Fifth People's Hospital
Chengdu, China
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7
Sichuan Provincial People's Hospital
Chengdu, China
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8
Chongqing University Affiliated Fuling Central Hospital
Chongqing, China
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9
Deyang People's Hospital
Deyang, China
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10
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
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11
The First Affiliated Hospital of Jinan University
Guangzhou, China
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12
The First Affiliated Hospital Of University Of South China
Hengyang, China
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13
The Second Affiliated Hospital of Jiaxing University
Jiaxing, China
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14
The First People's Hospital of Lianyungang
Lianyungang, China
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15
Liuzhou Worker's Hospital
Liuzhou, China
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16
Mianyang Central Hospital
Mianyang, China
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17
Nanjing Drum Tower Hospital
Nanjing, China
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18
The Second Nanning People's Hospital
Nanning, China
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19
Ningbo Medical Center LIHUILI Hospital
Ningbo, China
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20
Ningbo NO.2 Hospital
Ningbo, China
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21
Shanxi Bethune Hospital
Taiyuan, China
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22
The First Affiliated Hospital of Wannan Medical College
Wuhu, China
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23
Affiliated Hospital of Jiangnan University
Wuxi, China
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24
Xi'an Honghui Hospital
Xi'an, China
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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