Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Static and dynamic pain scores until post-operative day 2 (POD 2)
研究概览
简要总结
The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II, & III patients
- •Elective primary total knee arthroplasty
- •Spinal Anesthesia
排除标准
- •Patients refusing consent
- •Contraindications to regional anesthesia
- •Pre-existing neurological disease
- •Allergy/contraindication to drugs used in the study
- •Revision knee arthroplasty
- •Patients with chronic pain/on narcotics preoperatively
- •Pre-existing Rheumatoid Arthritis/Ankylosing Spondylitis
- •Alcohol or drug abuse
- •Psychiatric disorders
- •Inability to use the outcome assessment tools
- •Wheel chair or walker dependent for mobilization
研究组 & 干预措施
Periarticluar Multimodal Technique
干预措施: Periarticular Injection (Drug)
CFNB plus Posterior Capsular Injection
干预措施: CFNB + Posterior Capsular Injection (Drug)
结局指标
主要结局
Static and dynamic pain scores until post-operative day 2 (POD 2)
时间窗: 9:00 and 15:30 daily for the first 2 postoperative days
次要结局
- Number of patients able to mobilize with or without a frame(POD 1-2)
- Hospital length of stay(Until Hospital discharge)
- Equivalent narcotic consumption until POD 2(9:00 and 15:30 daily until POD 2)
- Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range(9:00 and 15:30 daily until POD 2)
- Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)(9:00 and 15:30 daily until POD 2)
- Number of patients requiring Ketamine and ketamine dosage for intractable pain(9:00 and 15:30 daily until POD 2)
- Number of patients requiring Cryo-Cuff for intractable pain(9:00 and 15:30 daily until POD 2)
- Maximum knee flexion (active/passive)(POD 1-2, at discharge, and at first follow-up visit)
- Patient satisfaction scores(POD 0-2, at hospital discharge, and at first postoperative follow-up visit)