Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative pain scores on the Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.
详细描述
In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective rhinoplasty operation under general anesthesia
- •Patients with ASA (American Society of Anesthesiology) class I
- •Patients between 18-50 years old
排除标准
- •Age <18 and >50
- •ASA > II
- •Preexisting neurological or psychiatric illness
- •Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
- •Having a history of chronic pain and receiving chronic analgesia therapy
- •Having a history of drug abuse
研究组 & 干预措施
Group L (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.
干预措施: Lidocaine 2 % (Drug)
Group K (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity.
干预措施: Ketamine plus Lidocaine (Drug)
Group S (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative pain scores on the Visual Analogue Scale
时间窗: 24 hours
Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS\>40 will receive 1mg/kg tramadol.
次要结局
- Patient satisfaction(24 hour)
- Analgesic demand(24 hour)