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Completed

NCT Number: NCT01111513

The Influence of the Femoral Nerve Block on Quadriceps Strength

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

48-hour ropivacaine infusions

Drug

Patients receive 20 ml of ropivacaine 0.5 % pre-operation through femoral block catheter, followed by ropivacaine infusions from 0.1 % to 0.1 ml/kg/hour for 48 hours.

Other names: ropivacaine, femoral block

single dose ropivacaine

Drug

Patients receive 20 ml of ropivacaine 0.5% pre-operation

Other names: ropivacaine

Patient controlled analgesics

Drug

Patient controlled analgesics alone, no femoral block

Other names: analgesics

Primary outcomes

  1. Quadriceps strength measurement with Cybex machine

    Time frame: 6 weeks 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.

  2. Quadriceps strength measurement with Cybex machine

    Time frame: 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.

  3. Quadriceps strength measurements with Cybex machine

    Time frame: 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.

Secondary outcomes

  1. Overall functional recovery

    Time frame: 6 weeks after surgery

    The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.

  2. Pain score on Visual Analog Scale (VAS)

    Time frame: every 6 hour for the 48 hours following surgery

    Evaluation of the effectiveness of the analgesics on pain with VAS .

  3. Hospital stay length

    Time frame: 4 to 7 days after surgery

    Evaluation of the hospital stay length after total knee replacement taking into account the different types of analgesics.

  4. Overall functional recovery

    Time frame: 6 months after surgery

    The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.

  5. Overall functional recovery

    Time frame: 12 months after surgery

    The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.

Sponsors and collaborators

Lead sponsor

Hopital de l'Enfant-Jesus

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Apr 27, 2010
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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