Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Timed-Up and Go-test for mobility evaluation
研究概览
简要总结
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with knee replacement therapy and general anaesthesia
- •informed consent
- •preoperative "timed up and go" test performable
排除标准
- •emergency patients
- •BMI > 40 kg/m2
- •American Society of Anaesthesiologists physical status (ASA) 4-5
- •severe chronic obstructive pulmonary disease (COPD)
- •rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
- •nerve injury of lumbosacral plexus
- •coagulopathy with bleeding tendency
- •not capable of speaking or understanding german or english
研究组 & 干预措施
Continuous Adductor Canal Block (CACB)
Continuous Adductor Canal block performed with:
loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h
Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine
干预措施: Ropivacaine (Drug)
Continuous Femoral Nerve Block (CFNB)
Continuous Femoral Nerve Block performed with:
loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h
Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Timed-Up and Go-test for mobility evaluation
时间窗: third postoperative day
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
次要结局
- Quadriceps strength(6, 24, 28, 72 hours postoperative)
- Pain Scores(6, 24, 48, 72 hours postoperative)
- Ropivacaine consumption (each catheter)(24, 48, 72 hours postoperative)
- Mobility Score (MoSc)(24,48,72 hours postoperative)
- Analgesic regimen(preop and 0, 6 , 24, 48, 48 hours postoperative)
- CAS (Cumulated Ambulation Score)(24,48,72 hours postoperative)
研究者
Karolin Piechowiak
Dr. Karolin Piechowiak
Philipps University Marburg Medical Center