Defining the Best Approach to Block the Pain After Knee Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- pain relief; measured by VAS at rest and on activity
研究概览
简要总结
The study aims to compare standard techniques used to control pain after knee surgery. The investigators hypothesize that the fascia iliaca block is faster, safer and as good as or better than the femoral block, with or without a stimulating catheter.
详细描述
60 patients being treated for ACL repair or knee arthroplasties under regional anesthesia will be randomized to three groups: Fascia Iliaca Block (FIB), Femoral Block (FB) with stimulating catheter or FB without stimulating catheter. A catheter will be placed according to each technique, before the surgery. A bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. A continuous infusion will be started for 48 hours. All patients receive a standard analgesia cocktail and rescue medication.
Pain and level of activity, as well as side effects, will be evaluated.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients coming for ACL or knee prosthesis surgery
- •Between 18-80 years old
- •Consenting for spinal anesthesia
排除标准
- •Major neurologic diseases
- •Obesity with body mass index (BMI) > 30
- •Infection at the punction sites (back and/or groin)
- •Diabetes mellitus for longer than 5 years
- •Coagulopathy
结局指标
主要结局
pain relief; measured by VAS at rest and on activity
时间窗: before surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90
pain relief; measured by WOMAC
时间窗: before surgery and at days 7, 60, 90
pain relief; evaluated from standard datasheet
时间窗: over 48-hour period
次要结局
- knee range of bending(measured before surgery, and at days 7, 60, 90)
- thigh circumference 20 cm above the knee(measured before surgery and at days 7, 60, 90)
- neurological exam of femorocutaneous, femoral and obturator nerves(evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia)
- level of activity; measured using questionnaire(at 7-10 days and at 2 and 3 months)
- need for rescue analgesia(in recovery room and at home)
- need for second bolus or crossing over between groups