NCT06949852已完成3 期
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
Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd24 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2024年8月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 289
- 试验地点
- 24
- 主要终点
- Sum of Pain Intensity Difference over 0-48 hours(SPID48)
研究概览
简要总结
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years (inclusive), regardless of gender.
- •Weight 45-100 kg (inclusive) and BMI 18.0-30.0 kg/m² (inclusive).
- •Preoperative ASA Physical Status Class I-III.
- •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.
- •Ability to comprehend study objectives, operate PCIA devices, and communicate effectively with investigators.
- •Female subjects must be non-pregnant, non-lactating, and agree to use contraception (including partners) for 3 months post-study.
- •Voluntary participation with signed informed consent.
排除标准
- •Known or suspected allergy/hypersensitivity to any component of the investigational product, other opioids, or contraindicated drugs specified in the protocol .
- •Neurological/psychiatric disorders including:
- •Clinically significant neurological diseases (e.g., epilepsy, cognitive impairment) .
- •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 .
- •Cardiovascular diseases/history:
- •Severe cardiovascular conditions (NYHA Class II or higher), myocardial infarction, angina, or severe arrhythmia within the past year .
- •Abnormal 12-lead ECG findings during screening (e.g., sinus bradycardia ≤55 bpm, ≥Grade II AV block) deemed unsuitable by the investigator .
- •Resting systolic blood pressure ≥160 mmHg or <90 mmHg, diastolic ≥100 mmHg pre-surgery .
- •Intraoperative circulatory instability (e.g., hypotension, bradycardia) assessed as high-risk for trial continuation .
- •Respiratory disorders/history:
- •Bronchial asthma, high-risk respiratory depression conditions (e.g., severe COPD ≥GOLD 3, sleep apnea syndrome) .
- •Preoperative SpO2 <93% (room air) or intraoperative respiratory depression/ventilatory dysfunction deemed unsafe .
- •Paralytic ileus, biliary/pancreatic diseases within 12 months before screening .
- •Major surgery within 3 months prior to screening.
- •Acute/chronic non-surgical pain interfering with postoperative pain assessment .
- •Preoperative anemia: Hemoglobin <70 g/L or hematocrit <25% .
- •High bleeding risk:
- •Congenital bleeding disorders (e.g., hemophilia) .
- •Platelet count <0.75×LLN, PT >ULN+3s, or APTT >ULN+10s .
- •Organ dysfunction:
- •Albumin <35 g/L (untreated) .
- •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) .
- •Random blood glucose ≥11.1 mmol/L during screening (preoperative) .
- •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.
研究组 & 干预措施
Morphine group
Active Comparator
干预措施: Morphine Hydrochloride Injection (Drug)
Nalbuphine group
Experimental
干预措施: Nalbuphine Hydrochloride Injection (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference over 0-48 hours(SPID48)
时间窗: 0-48 hours
SPID48=∑PID48×\[time in hours slapsed since the previous observation\], PID48 denotes the pain intensity difference at time 48 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
次要结局
- Sum of Pain Intensity Difference over 0-12 hours(SPID12)(0-12 hours)
- Sum of Pain Intensity Difference over 0-24 hours(SPID24)(0-24 hours)
- Sum of Pain Intensity Difference over 0-32 hours(SPID32)(0-32 hours)
- Total Number of PCIA Pump attempts during 0~48h(0-48 hours)
- Number of Effective Deliveries during 0~48h(0-48 hours)
- Total Delivered Dose during 0~48h(0-48 hours)
- Time to First Use of Rescue Medication(0-48 hours)
- Proportion of Subjects Requiring Rescue Medication(0-48 hours)
- Number of Rescue Medication Administrations(0-48 hours)
- Proportion of Subjects with Treatment Failure(0-48 hours)
- Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose(0-48 hours)
研究者
研究点 (24)
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