Postoperative Analgesia in Patients Undergoing Knee Replacement Surgery - a Study Comparing Intraoperative Local Infiltration Analgesia Only With Ultrasound-guided Nerve Blocks Added to Intraoperative Local Infiltration Analgesia, a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.
详细描述
Scientific Rationale and Background Total Knee Arthroplasty (TKA) requires effective perioperative pain management. Traditionally, Local Infiltration Analgesia (LIA)has been the standard method, sometimes combined with femoral nerve block. However, femoral nerve block impairs quadriceps motor function, making early mobilization-critical for postoperative rehabilitation-difficult for participants.
Recent advances have introduced purely sensory nerve block techniques that preserve motor function. The knee joint innervation is complex and involves multiple neural pathways. The Saphenous Nerve (SN), Nervus Vastus Medialis (NVM), and the Anterior Femoral Cutaneous Nerve (AFCN) are all branches of the femoral nerve that provide sensory innervation to the knee without contributing to motor control of the quadriceps. The adductor canal contains the SN and NVM, which are primarily sensory nerves. The AFCN travels superficially in the femoral triangle and innervates the skin of the anterior and medial thigh.
Studies have shown that adductor canal block (targeting SN and NVM) combined with LIA provides comparable pain relief to femoral nerve block without motor impairment. Additionally, the AFCN contributes to sensory innervation of the anterolateral and anteromedial aspects of the knee joint. Our hypothesis is that combining these three sensory blocks (SN, NVM, and AFCN) with LIA may provide superior pain control and reduced opioid consumption compared to LIA alone, while preserving motor function necessary for early mobilization.
Primary Research Questions
- Does the combination of the SN block, the NVM block of and the AFCN block togheter with LIA provide better postoperative pain control compared to LIA alone?
- Does the above combination reduce total postoperative opioid consumption? Secondary Research Questions
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 (Care Provider, Outcomes Assessor)
盲法说明
Outcome assessor blinded; staff registering NRS pain scores and opioid consumption are blinded to group allocation. No sham block is used in the control group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing primary unilateral total knee arthroplasty
排除标准
- •Pregnancy
- •Coagulopathy or other bleeding disorder that precludes regional anesthesia
- •Allergy to local anesthetics
- •Inability to understand spoken and written Swedish
- •Unwillingness to participate in the study