The Influence of the Femoral Nerve Block on Quadriceps Strength

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: Single dose ropivacaine; Drug: Patient controlled analgesics; Drug: 48-hour ropivacaine infusions

• Registration Number: NCT01111513
• Lead Sponsor: Hopital de l'Enfant-Jesus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-27
• Primary Completion: 2011-03
• Study Completion: 2012-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose femoral block	Single dose ropivacaine	Patients receive a single dose femoral block and have patient controlled analgesics.
Patient controlled analgesics	Patient controlled analgesics	Patients do not receive a femoral block. They only have patient controlled analgesics.
Continuous femoral block	48-hour ropivacaine infusions	Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics.

Primary Outcome Measures

Name	Time	Method
Quadriceps strength measurement with Cybex machine	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	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 Outcome Measures

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

Trial Locations

Locations (1)

CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada