The Influence of the Femoral Nerve Block on Quadriceps Strength

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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: 48-hour ropivacaine infusions; Drug: Single dose ropivacaine; Drug: Patient controlled analgesics

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • CHA-Pavillon Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus
• Collaborators: Sanofi
• Investigators: Principal Investigator: Michèle Angers, PhD, Hôpital Enfant-Jésus

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: total knee replacement; total knee arthroplasty; knee surgery; ropivacaine; femoral nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Analgesics
• Other Study ID Numbers: PEJ-413