A Phase II, Randomized, Double-Blind Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.
试验速览
- 阶段
- 2 期
- 入组人数
- 108
- 主要终点
- the Sum of Pain Intensity Differences in Pain Score Over 24 Hours
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia abdominal surgery
- •Conform to the ASA Physical Status Classification
排除标准
- •Subjects with a history of difficult airway
- •Subjects with a history of reflux esophagitis
- •Subjects with a history of mental illness
- •Subjects with poor blood pressure control
- •Random blood glucose ≥11.1mmol/L
- •Subjects with abnormal liver function
- •allergies to opioids and other medications that may be used during the trial
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group A: SHR8554 Injection and SHR0410 Injection
干预措施: SHR8554 Injection and SHR0410 Injection (Drug)
Treatment group B: SHR8554 Injection and SHR0410 Injection
干预措施: SHR8554 Injection and SHR0410 Injection (Drug)
Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection
干预措施: SHR8554 Injection and Placebo for SHR0410 Injection (Drug)
结局指标
主要结局
the Sum of Pain Intensity Differences in Pain Score Over 24 Hours
时间窗: 24-hours
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
次要结局
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、12-24 Hours(6-hours、12-hours、12-24 hours)
- Time of first use of remedial analgesic medication(24-hours)
- Cumulative use of remedial analgesics from 0h to 24h(24-hours)
- Participant ' satisfaction score for analgesia treatment(24-hours)
- Investigator satisfaction score for analgesia treatment(24-hours)