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临床试验/NCT01111513
NCT01111513已完成不适用

The Influence of the Femoral Nerve Block on the Quadriceps Strength After Total Knee Replacement

Hopital de l'Enfant-Jesus1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2007年11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
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
Quadriceps strength measurement with Cybex machine

研究概览

简要总结

Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Thus, the importance of the patient's recovery leads to the evaluation of the influence of the femoral nerve block on the muscle strength.

The purpose of the study is to compare the short term and long term recuperation of the quadriceps' motor strength of after a total knee arthroplasty using different types of analgesics such as the continuous femoral nerve block, the single dose femoral nerve block and the systemic analgesic, a patient controlled analgesic pump.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years old
  • men or women needing an elective total knee replacement surgery

排除标准

  • unicompartmental arthroplasty
  • revision surgery for knee arthroplasty
  • previous surgery on same knee
  • previous fracture of femur/patella with functional after-effects
  • allergies or contraindication to any medication used during study or to local anaesthesia technique
  • preexisting neurological deficit
  • severe anomaly of intracardiac conduction
  • previous vascular surgery near the site of introduction of the catheter
  • pregnancy or breastfeeding
  • ASA IV or V14 class
  • Men or women > 18 years old unfit to consent
  • < 18 years old
  • Refusal to sign consent form

研究组 & 干预措施

Single dose femoral block

Active Comparator

Patients receive a single dose femoral block and have patient controlled analgesics.

干预措施: Single dose ropivacaine (Drug)

Continuous femoral block

Active Comparator

Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics.

干预措施: 48-hour ropivacaine infusions (Drug)

Patient controlled analgesics

Active Comparator

Patients do not receive a femoral block. They only have patient controlled analgesics.

干预措施: Patient controlled analgesics (Drug)

结局指标

主要结局

Quadriceps strength measurement with Cybex machine

时间窗: 6 months after surgery

Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.

Quadriceps strength measurements with Cybex machine

时间窗: 12 months after surgery

Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.

次要结局

  • Overall functional recovery(12 months after surgery)
  • Pain score on Visual Analog Scale (VAS)(every 6 hour for the 48 hours following surgery)
  • Hospital stay length(4 to 7 days after surgery)

研究者

发起方
Hopital de l'Enfant-Jesus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pelet Stephane

Dr Stephane Pelet MD, PhD Orthopedic surgeon

Hopital de l'Enfant-Jesus

研究点 (1)

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