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临床试验/NCT02387021
NCT02387021Unknown不适用

Prospective Comparison Between Continuous Femoral Nerve Block and the Association of Adductor Canal Block and Sciatic Nerve Block in Total Knee Arthroplasty.

Institut Kassab d'Orthopédie0 个研究点目标入组 80 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Total Opioid-consumption

研究概览

简要总结

The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective unilateral TKA,
  • Planned continuous spinal anesthesia ,
  • Ability to follow study protocol,
  • American Society of Anesthesiologists class 1 to 3.

排除标准

  • Contraindication for neuraxial anesthetic,
  • Chronic opioid use (defined as daily or almost daily use of opioids for >3 months),
  • Hypersensitivity and/or allergies to any of the study medications,
  • Intraoperative use of volatile anesthetics,
  • Preexisting neuropathy on the operative limb,
  • Contraindications to a femoral, adductor canal or Tibial nerve block.

研究组 & 干预措施

Continous femoral nerve block

Active Comparator

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

干预措施: Continuous femoral nerve block (Procedure)

Continous femoral nerve block

Active Comparator

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

干预措施: Continuous adductor canal block (Procedure)

Continous femoral nerve block

Active Comparator

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

干预措施: infragluteal Sciatic nerve block (Procedure)

Continous femoral nerve block

Active Comparator

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

干预措施: Ropivacaine 0.2% (Drug)

Continous femoral nerve block

Active Comparator

Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline .

干预措施: Saline (Drug)

Continuous adductor canal block

Experimental

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

干预措施: Continuous femoral nerve block (Procedure)

Continuous adductor canal block

Experimental

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

干预措施: Continuous adductor canal block (Procedure)

Continuous adductor canal block

Experimental

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

干预措施: infragluteal Sciatic nerve block (Procedure)

Continuous adductor canal block

Experimental

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

干预措施: Ropivacaine 0.2% (Drug)

Continuous adductor canal block

Experimental

Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline .

干预措施: Saline (Drug)

结局指标

主要结局

Total Opioid-consumption

时间窗: 8 hours postoperative

Cumulative opioid consumption : converting oral, intravenous, and patient-controlled analgesia PCA opioid to morphine equivalent

次要结局

  • NRS pain score at rest(0,1,2,4,6,8,12,24 and 48 hours postoperative)
  • NRS pain score during movement(0,1,2,4,6,8,12,24 and 48 hours postoperative)
  • patient satisfaction(8, 24 and 48 hours postoperative)
  • Ability to walk(8, 24 and 48 hours postoperative)
  • NRS pain score after 10 meters of walk or maximum walked distance(8, 24 and 48 hours postoperative)
  • TUG Test(8, 24 and 48 hours postoperative)
  • The 10-m walk test(8, 24 and 48 hours postoperative)

研究者

发起方
Institut Kassab d'Orthopédie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rais Karim

Dr

Institut Kassab d'Orthopédie

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