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The Influence of the Femoral Nerve Block on Quadriceps Strength

NCT ID: NCT01111513

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Total Knee Arthroplasty

Keywords

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knee surgery total knee arthroplasty total knee replacement ropivacaine femoral nerve block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous femoral block

Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics.

Group Type ACTIVE_COMPARATOR

48-hour ropivacaine infusions

Intervention Type DRUG

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 femoral block

Patients receive a single dose femoral block and have patient controlled analgesics.

Group Type ACTIVE_COMPARATOR

Single dose ropivacaine

Intervention Type DRUG

Patients receive 20 ml of ropivacaine 0.5% pre-operation

Patient controlled analgesics

Patients do not receive a femoral block. They only have patient controlled analgesics.

Group Type ACTIVE_COMPARATOR

Patient controlled analgesics

Intervention Type DRUG

Patient controlled analgesics alone, no femoral block

Interventions

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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.

Intervention Type DRUG

Single dose ropivacaine

Patients receive 20 ml of ropivacaine 0.5% pre-operation

Intervention Type DRUG

Patient controlled analgesics

Patient controlled analgesics alone, no femoral block

Intervention Type DRUG

Other Intervention Names

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ropivacaine femoral block ropivacaine analgesics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Hopital de l'Enfant-Jesus

OTHER

Sponsor Role lead

Responsible Party

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Pelet Stephane

Dr Stephane Pelet MD, PhD Orthopedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stéphane Pelet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Michèle Angers, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Locations

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CHA-Pavillon Enfant-Jésus

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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PEJ-413

Identifier Type: -

Identifier Source: org_study_id