Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Numerical Rating Pain Scale
研究概览
简要总结
This study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. The investigators will randomize patients into three groups to compare the analgesia effects and side effects.
详细描述
Nalbuphine is a FDA approved noncontrolled drug of opioid. And it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine.
However, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. If the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid.
The investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. If the pain or side effects of opioid were intolerable, the investigators will change pain medications into NSAIDs or other adequate medications to comfort the patient.
The primary outcome were numerical rating pain score and consumption of nalbuphine. The secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient accept laparoscopic cholecystectomy
- •age:20-80 years old
排除标准
- •nalbuphine allergy
- •chronic pain
- •active liver disease that would affect metabolization of nalbuphine
- •patient who had regular pain medications
- •patient who could not cooperate to the evaluation of the survey
- •dementia or other psychiatric disease
研究组 & 干预措施
group A
mutonpain 0.05 mg/kg
干预措施: group A (Drug)
Group B
mutonpain 0.1 mg/kg
干预措施: group B (Drug)
Group C
mutonpain 0.2 mg/kg
干预措施: group C (Drug)
结局指标
主要结局
Numerical Rating Pain Scale
时间窗: numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The investors will measure the pain score at rest state and upon movement state at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours.
consumption of nalbuphine
时间窗: Record the opioid dose changes 2 days.
The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.
次要结局
- use of rescue pain medications(record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours)
- nausea(the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours)
- vomiting(the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours)
- satisfactory score by net promoter score(2 days)
研究者
KMUHIRB-F(I)-20190070
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital