Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Emergence agitation
研究概览
简要总结
The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.
详细描述
Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septorhinoplasty
- •American Society of Anesthesiologists (ASA) classification I-II
- •Written informed consent
排除标准
- •ASA classification greater than III
- •Allergy to ropivacaine
- •Incapability to give consent
- •Chronic pain
- •Coagulopathy
研究组 & 干预措施
Control
placebo for the realization of infraorbital and infratrochlear block
干预措施: Normal Saline (Drug)
Ropivacaine
ropivacaine for the realization of infraorbital and infratrochlear block
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Emergence agitation
时间窗: 2 hours after surgery
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7
次要结局
- Pain intensity(2, 8, 24, 48 hours after surgery)
- Patient satisfaction(48 hours after surgery)
研究者
Hoon Choi
M.D. Department of Anesthesiology and Pain Medicine, Armed Forces Hampyeong Hospital
Armed Forces Hampyeong Hospital