NCT04697329已完成4 期
Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
Hospital Universitario de Móstoles1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2020年12月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Postoperative pain assessed by visual numeric scale.
研究概览
简要总结
Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.
Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Elective laparoscopic cholecystectomy
排除标准
- •Patient refusal
- •Open surgery
- •Reintervention surgery
- •Drain tube placement
- •Cognitive impairment
- •Allergic reactions to local anesthetics
研究组 & 干预措施
Local infiltration
Experimental
干预措施: Preincisional infiltration with levobupivacaine (Drug)
结局指标
主要结局
Postoperative pain assessed by visual numeric scale.
时间窗: 24 hours
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Best outcome would be 0 or close to 0
次要结局
- Postoperative administration of analgesics(24 hours)
- Postoperative nausea and vomiting episodes(24 hours)
研究者
JORGE HERRADOR BENITO
Principal Investigator. Surgeon.
Hospital Universitario de Móstoles
研究点 (1)
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