ESPB 与 iPACK+ACB 在全膝关节置换术中的比较
竖脊肌平面阻滞与带有内收肌管阻滞的 iPACK 阻滞对比，用于全膝关节置换术患者的疼痛管理
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty
研究概览
地位
详细说明
Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the surgery's induced stress response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.
This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Poznań
-
Poznan、Poznań、波兰、61-701
- Poznan University of Medical Sciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.
Exclusion Criteria:
- patients who have a history of bleeding diathesis,
- take anticoagulant therapy,
- have a History of chronic pain before surgery,
- have Multiple trauma, cannot assess their pain (dementia),
- have been operated on under general anaesthesia,
- have an infection in the area and do not accept the procedure
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：iPACK + ACB
spinal anesthesia + ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine) |
iPACK block + Adductor Canal Block
其他名称：
Erector Spinae Plane Block
其他名称：
|
|
有源比较器：Erectro Spinae Plane Block
spinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine |
iPACK block + Adductor Canal Block
其他名称：
Erector Spinae Plane Block
其他名称：
|
|
安慰剂比较：Control group
Only spinal anesthesia - No peripheral nerve block |
only spinal anesthesia
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Opioid consumption
大体时间：48 hours after surgery
|
Total opiate consumption after surgery |
48 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first rescue opiate analgesia
大体时间：48 hours after procedure
|
Time after surgery when the patient needs opiate for the first time |
48 hours after procedure
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 4 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 4 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 8 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 8 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 12 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 12 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 16 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 16 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 20 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 20 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 24 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 24 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 36 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 36 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
大体时间：Time Frame: 48 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 48 hours after surgery
|
|
Neutrophil-to-lymphocyte ratio
大体时间：24 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
24 hours after surgery
|
|
Neutrophil-to-lymphocyte ratio
大体时间：48 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
48 hours after surgery
|
|
Platelet-to-lymphocyte ratio
大体时间：24 hours after surgery
|
Platelet-to-lymphocyte ratio |
24 hours after surgery
|
|
Platelet-to-lymphocyte ratio
大体时间：48 hours after surgery
|
Platelet-to-lymphocyte ratio |
48 hours after surgery
|
|
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
大体时间：Postoperative 24 hours period
|
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating |
Postoperative 24 hours period
|
合作者和调查者
调查人员
- 学习椅：Łukasz Łapaj, Ph.D.、Poznań University of Medical Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5/2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Please provide the plan description
IPD 共享时间框架
6 month after study completion
IPD 共享访问标准
from the corresponding author on the resonable request
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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