The Influence of the Femoral Nerve Block on Quadriceps Strength
19. december 2012 opdateret af: Pelet Stephane, Hopital de l'Enfant-Jesus
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
135
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Quebec
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Québec, Quebec, Canada, G1J 1Z4
- CHA-Pavillon Enfant-Jésus
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Continuous femoral block
Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics.
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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.
Andre navne:
|
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Aktiv komparator: Single dose femoral block
Patients receive a single dose femoral block and have patient controlled analgesics.
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Patients receive 20 ml of ropivacaine 0.5% pre-operation
Andre navne:
|
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Aktiv komparator: Patient controlled analgesics
Patients do not receive a femoral block.
They only have patient controlled analgesics.
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Patient controlled analgesics alone, no femoral block
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quadriceps strength measurement with Cybex machine
Tidsramme: 6 weeks after surgery
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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.
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6 weeks after surgery
|
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Quadriceps strength measurement with Cybex machine
Tidsramme: 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.
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6 months after surgery
|
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Quadriceps strength measurements with Cybex machine
Tidsramme: 12 months after surgery
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall functional recovery
Tidsramme: 6 weeks after surgery
|
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
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6 weeks after surgery
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Pain score on Visual Analog Scale (VAS)
Tidsramme: every 6 hour for the 48 hours following surgery
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Evaluation of the effectiveness of the analgesics on pain with VAS .
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every 6 hour for the 48 hours following surgery
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Hospital stay length
Tidsramme: 4 to 7 days after surgery
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Evaluation of the hospital stay length after total knee replacement taking into account the different types of analgesics.
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4 to 7 days after surgery
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Overall functional recovery
Tidsramme: 6 months after surgery
|
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
|
6 months after surgery
|
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Overall functional recovery
Tidsramme: 12 months after surgery
|
The overall functional recovery of the patient will be evaluated considering the analgesic type using SF-36 and WOMAC questionnaires.
|
12 months after surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michèle Angers, PhD, Hôpital Enfant-Jésus
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2007
Primær færdiggørelse (Faktiske)
1. marts 2011
Studieafslutning (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først indsendt
21. april 2010
Først indsendt, der opfyldte QC-kriterier
23. april 2010
Først opslået (Skøn)
27. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PEJ-413
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .