Comparison of Efficacy Between Bilateral Superficial Cervical Plexus Block and Local Infiltration of Lidocaine 2% in Patients Undergoing Tracheostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Concentration of substance-P (Baseline)
研究概览
简要总结
The aim of this study was to compare the efficacy between superficial cervical plexus block and local infiltration of lidocaine 2% in patients undergoing tracheostomy procedure.
详细描述
Ethical approval was obtained from Ethics Committee of Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital.
Eligible subjects for this study will be recruited with consecutive sampling method within certain period until minimum number of subjects required for this study is filled.
Informed consents will be given to each subject before participating in the study. Patients will be randomly divided into two groups using closed envelops.
Subjects who will receive bilateral superficial cervical plexus block is the interventional group whereas subjects who will receive local infiltration of lidocaine 2% is the control group.
Before, during, and after the procedure, all subjects are monitored (blood pressure, heart rate, respiratory rate, and electrocardiography). Monitoring data, including pain, will be recorded. Pain is measured by using visual analog scale or verbal numeric rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Physical Status ASA 1-3
排除标准
- •Blood clotting disorder
- •Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
- •Local infection on procedure area
- •Deformity on procedure area
结局指标
主要结局
Concentration of substance-P (Baseline)
时间窗: 3 months
Substance-P level is measured as a pain indicator.
Concentration of substance-P (After Tracheostomy)
时间窗: 3 months
Substance-P level is measured as a pain indicator.
次要结局
未报告次要终点
研究者
Pryambodho Pryambodho
Medical Staff in Department of Anesthesiology and Intensive Care
Indonesia University