NCT03713216已完成4 期
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Postoperative pain score
研究概览
简要总结
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.
详细描述
This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after 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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with 20 years old or older.
- •Scheduled to electively undergo laparoscopic cholecystectomy.
- •Ability and willingness to provide informed consent.
排除标准
- •Not willing to adhere to the study visit schedule and complete all study assessments.
- •History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
- •Any clinically significant condition that may interfere with study assessments or compliance.
- •Pregnant or breastfeeding.
- •Medical history may cause abnormal intracranial pressure.
- •History of dependency, addiction, and withdrawal for narcotic drugs.
研究组 & 干预措施
Naldebain
Experimental
Subjects will receive one dose of Naldebain before surgery.
干预措施: Naldebain (Drug)
Morphine
Active Comparator
Subjects will receive morphine after surgery.
干预措施: Morphine (Drug)
结局指标
主要结局
Postoperative pain score
时间窗: 24 hours after surgery
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
次要结局
- Consumption of supplemental analgesics(From Day 0 to Day 3)
研究者
研究点 (1)
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