The Influence of the Femoral Nerve Block on Quadriceps Strength

Study Overview
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Brief Summary
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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.

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

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Drug: 48-hour ropivacaine infusions
* Drug: Single dose ropivacaine
* Drug: Patient controlled analgesics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous femoral block<br>Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics. | Drug: 48-hour ropivacaine infusions<br>* 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.<br>* Other names: femoral block;|
| Active Comparator: Single dose femoral block<br>Patients receive a single dose femoral block and have patient controlled analgesics. | Drug: Single dose ropivacaine<br>* Patients receive 20 ml of ropivacaine 0.5% pre-operation<br>* Other names: ropivacaine;|
| Active Comparator: Patient controlled analgesics<br>Patients do not receive a femoral block. They only have patient controlled analgesics. | Drug: Patient controlled analgesics<br>* Patient controlled analgesics alone, no femoral block<br>* Other names: analgesics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps strength measurement with Cybex machine | 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. | 6 weeks after surgery | 
| Quadriceps strength measurement with Cybex machine | 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. | 6 months after surgery | 
| Quadriceps strength measurements with Cybex machine | 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. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall functional recovery | The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires. | 6 weeks after surgery | 
| Pain score on Visual Analog Scale (VAS) | Evaluation of the effectiveness of the analgesics on pain with VAS . | every 6 hour for the 48 hours following surgery | 
| Hospital stay length | Evaluation of the hospital stay length after total knee replacement taking into account the different types of analgesics. | 4 to 7 days after surgery | 
| Overall functional recovery | The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires. | 6 months after surgery | 
| Overall functional recovery | The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires. | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee surgery, total knee arthroplasty, total knee replacement, ropivacaine, femoral nerve block