Clinical trial NCT06949852: Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postoperative Analgesia
Lead sponsor: Yangtze River Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Sum of Pain Intensity Difference over 0-48 hours(SPID48)
timeFrame: 0-48 hours
Secondary outcomes:
measure: Sum of Pain Intensity Difference over 0-12 hours(SPID12)
timeFrame: 0-12 hours
measure: Sum of Pain Intensity Difference over 0-24 hours(SPID24)
timeFrame: 0-24 hours
measure: Sum of Pain Intensity Difference over 0-32 hours(SPID32)
timeFrame: 0-32 hours
measure: Total Number of PCIA Pump attempts during 0~48h
timeFrame: 0-48 hours
measure: Number of Effective Deliveries during 0~48h
timeFrame: 0-48 hours
measure: Total Delivered Dose during 0~48h
timeFrame: 0-48 hours
measure: Time to First Use of Rescue Medication
timeFrame: 0-48 hours
measure: Proportion of Subjects Requiring Rescue Medication
timeFrame: 0-48 hours
measure: Number of Rescue Medication Administrations
timeFrame: 0-48 hours
measure: Proportion of Subjects with Treatment Failure
timeFrame: 0-48 hours
measure: Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
city: Changde
country: China
facility: The First People's Hospital of Changde City
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South Univerdity
city: Changzhi
country: China
facility: Heping Hospital affiliated to Changzhi Medical College
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: Chongqing University Affiliated Fuling Central Hospital
city: Deyang
country: China
facility: Deyang People's Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Hengyang
country: China
facility: The First Affiliated Hospital Of University Of South China
city: Jiaxing
country: China
facility: The Second Affiliated Hospital of Jiaxing University
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
city: Mianyang
country: China
facility: Mianyang Central Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanning
country: China
facility: The Second Nanning People's Hospital
city: Ningbo
country: China
facility: Ningbo Medical Center LIHUILI Hospital
city: Ningbo
country: China
facility: Ningbo NO.2 Hospital
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
city: Xi'an
country: China
facility: Xi'an Honghui Hospital
Study officials:
References: