The Influence of the Femoral Nerve Block on Quadriceps Strength

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01111513
First received: April 21, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Total Knee Arthroplasty
Drug: 48-hour ropivacaine infusions
Drug: Single dose ropivacaine
Drug: Patient controlled analgesics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of the Femoral Nerve Block on the Quadriceps Strength After Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Quadriceps strength measurement with Cybex machine [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    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 measurement with Cybex machine [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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:
  • Overall functional recovery [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: every 6 hour for the 48 hours following surgery ] [ Designated as safety issue: No ]
    Evaluation of the effectiveness of the analgesics on pain with VAS .

  • Hospital stay length [ Time Frame: 4 to 7 days after surgery ] [ Designated as safety issue: No ]
    Evaluation of the hospital stay length after total knee replacement taking into account the different types of analgesics.

  • Overall functional recovery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.

  • Overall functional recovery [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.


Enrollment: 135
Study Start Date: November 2007
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: analgesics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111513

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Sanofi
Investigators
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
Principal Investigator: Michèle Angers, PhD Hôpital Enfant-Jésus
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01111513     History of Changes
Other Study ID Numbers: PEJ-413
Study First Received: April 21, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
knee surgery
total knee arthroplasty
total knee replacement
ropivacaine
femoral nerve block

Additional relevant MeSH terms:
Analgesics
Ropivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 31, 2014