Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Up and Go test
研究概览
简要总结
Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.
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
- Single (Participant)
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
- •patients undergoing total knee arthroplasty
排除标准
- •neurological disorders
- •coagulation disorders
- •rheumatoid arthritis
- •chronic opioids therapy
- •allergy to local anesthetic
研究组 & 干预措施
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Ropivacaine 0,75% (Drug)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Adductor canal (Procedure)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Spinal Anesthesia (Procedure)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Local anesthetic infusion (Procedure)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Intravenous analgesia (Procedure)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Levobupivacaine 0,5% (Drug)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Levobupivacaine 0,125% (Drug)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Ketorolac 30mg (Drug)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: Morphine (Drug)
Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
干预措施: stimulong sono, Pajunk, Germany (Device)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Femoral (Procedure)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Spinal Anesthesia (Procedure)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Local anesthetic infusion (Procedure)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Intravenous analgesia (Procedure)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Ropivacaine 0,75% (Drug)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Levobupivacaine 0,5% (Drug)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Levobupivacaine 0,125% (Drug)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Ketorolac 30mg (Drug)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: Morphine (Drug)
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
干预措施: stimulong sono, Pajunk, Germany (Device)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
干预措施: Spinal Anesthesia (Procedure)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
干预措施: Intravenous analgesia (Procedure)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
干预措施: Levobupivacaine 0,5% (Drug)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
干预措施: Ketorolac 30mg (Drug)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
干预措施: Morphine (Drug)
结局指标
主要结局
Up and Go test
时间窗: 5th postoperative day
Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair
次要结局
- Falling risk(5th postoperative day)
- VAS score(up to POD5)
- Morphine request(up to POD5)
- Range of motion(5th postoperative day)
- Quadriceps strength(5th postoperative day)
研究者
Gianluca Cappelleri
Medical Doctor
ASST Gaetano Pini-CTO