The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
研究概览
简要总结
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
详细描述
Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 50 years old, not exceed 100 years old
- •Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty
排除标准
- •Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
- •Accepted Revision Knee Arthroplasty
- •Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency
- •Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs
研究组 & 干预措施
Experimental Group
Nalbuphine Sebacate (Naldebain) intramuscular injection
干预措施: Nalbuphine Sebacate (Naldebain) (Drug)
Placebo Group
Placebo medication intramuscular injection
干预措施: Placebo medication (Drug)
结局指标
主要结局
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
时间窗: Post operation Day3
morphine consumption amount
The level of pain index (Visual Analog Scale)
时间窗: Post operation 6 weeks
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
次要结局
- knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)(Post operation 6 weeks)