Total Knee Arthroplasty Clinical Trial
Official title:
The Influence of the Femoral Nerve Block on the Quadriceps Strength After Total Knee Replacement
Verified date | December 2012 |
Source | Hopital de l'Enfant-Jesus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | February 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | CHA-Pavillon Enfant-Jésus | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Hopital de l'Enfant-Jesus | Sanofi |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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