The Influence of the Femoral Nerve Block on Quadriceps Strength

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111513
• Other study ID #: PEJ-413
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: December 19, 2012
• Start date: November 2007
• Est. completion date: February 2012

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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.
• Single dose ropivacaine
Patients receive 20 ml of ropivacaine 0.5% pre-operation
• Patient controlled analgesics
Patient controlled analgesics alone, no femoral block

Locations

Country	Name	City	State
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

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