Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Administration of analgesics or morphine in time
研究概览
简要总结
More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.
The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.
It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.
The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.
This study is planned to be a pilot study in order to complete a future large medical science study.
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
- Double (Participant, Investigator)
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
- •Planned resection of meniscus (DS832, DM232)
- •Planned meniscus suture (DS832)
- •Planned plica resection (DM659)
- •Patients >=18 years and <50 years
- •Statement of consent
- •Tolerance to Lidocaine (analgesics)
排除标准
- •Type 1 diabetes or type 2 diabetes
- •Allergic to Lidocaine (analgesics)
- •Heart disease, liver disease, kidney disease
- •BMI >=35
- •Unability to read or speak Danish
- •Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
- •Insufficient coagulation
- •Medication of morphine pre-operatively
- •Pregnant and nursing women
研究组 & 干预措施
Lidocaine adhesive tape
干预措施: Lidocaine adhesive tape (Drug)
Adhesive tape
干预措施: Adhesive tape (Other)
结局指标
主要结局
Administration of analgesics or morphine in time
时间窗: 1 day
First time administration of analgesics or morphine in time on demand
次要结局
- Discharges of patients in time(1 day)
- Value Added Score (VAS) estimation of pain(1 day)