Comparing Nalbuphine and Morphine for Pain Relief After Surgery

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Nalbuphine Versus Morphine for the Treatment of Postoperative Analgesia

This study tests whether Nalbuphine can provide better pain relief than Morphine for adults recovering from elective abdominal or orthopedic surgeries.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Yangtze River Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 24 sites (Beijing and 23 other locations)
• Trial ID: NCT06949852 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Nalbuphine compared to Morphine for postoperative pain management using patient-controlled intravenous analgesia (PCIA). It involves adult participants aged 18-65 who are undergoing elective abdominal or orthopedic surgeries. The study aims to determine which analgesic provides better pain relief while ensuring patient safety. Participants will be monitored for pain levels and any adverse effects following their surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 scheduled for elective abdominal or orthopedic surgery with a need for postoperative analgesia.

Not a fit: Patients with known allergies to opioids or those with significant neurological or psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management options for postoperative patients, potentially reducing reliance on traditional opioids.

How similar studies have performed: Previous studies have shown varying success with alternative analgesics, but this specific comparison of Nalbuphine and Morphine is less commonly explored.

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.

Where this trial is running

Beijing and 23 other locations

• Peking University First Hospital — Beijing, China (Recruiting)
• Cangzhou People's Hospital — Cangzhou, China (Recruiting)
• The First People's Hospital of Changde City — Changde, China (Recruiting)
• The Third Xiangya Hospital of Central South Univerdity — Changsha, China (Recruiting)
• Heping Hospital affiliated to Changzhi Medical College — Changzhi, China (Recruiting)
• Chengdu Fifth People's Hospital — Chengdu, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Recruiting)
• Chongqing University Affiliated Fuling Central Hospital — Chongqing, China (Recruiting)
• Deyang People's Hospital — Deyang, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital Of University Of South China — Hengyang, China (Recruiting)
• The Second Affiliated Hospital of Jiaxing University — Jiaxing, China (Recruiting)
• The First People's Hospital of Lianyungang — Lianyungang, China (Recruiting)
• Liuzhou Worker's Hospital — Liuzhou, China (Recruiting)
• Mianyang Central Hospital — Mianyang, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, China (Recruiting)
• The Second Nanning People's Hospital — Nanning, China (Recruiting)
• Ningbo Medical Center LIHUILI Hospital — Ningbo, China (Recruiting)
• Ningbo NO.2 Hospital — Ningbo, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, China (Recruiting)
• The First Affiliated Hospital of Wannan Medical College — Wuhu, China (Recruiting)
• Affiliated Hospital of Jiangnan University — Wuxi, China (Recruiting)
• Xi'an Honghui Hospital — Xi'an, China (Recruiting)

Conditions Postoperative Analgesia