Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
研究概览
简要总结
A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.
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
- •Outpatient rhinoplasty
- •American Society of Anesthesiologists (ASA) classification I-II
- •Affiliated to Social Security
- •Written informed consent
排除标准
- •Allergy to levobupivacaine
- •Incapacity to give consent
- •Chronic pain
研究组 & 干预措施
Control
placebo for the realization of the facial block and morphine for intraoperative analgesia
干预措施: Bilateral facial block after general anesthesia before surgery (Drug)
Levobupivacaine
Levobupivacaine for the realization of the facial block and placebo for intraoperative analgesia
干预措施: Bilateral facial block after general anesthesia before surgery (Drug)
结局指标
主要结局
Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
时间窗: J0
At the end of post-anesthesia care unit stay
次要结局
- Pain intensity in post-anesthesia care unit(J0 (At arrival in post-operative care unit))
- Postoperative nausea and vomiting(J1 (At day 1 after surgery))
- Patient satisfaction at day 1(J1 (At day 1 after surgery))