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- Register voor klinische proeven in de VS.
- Klinische proef NCT02125903
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Marburg, Duitsland, 35037
- University of Marburg Department of Anaesthesia And Intensive Care Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- patients with knee replacement therapy and general anaesthesia
- informed consent
- preoperative "timed up and go" test performable
Exclusion Criteria:
- emergency patients
- BMI > 40 kg/m2
- American Society of Anaesthesiologists physical status (ASA) 4-5
- severe chronic obstructive pulmonary disease (COPD)
- rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
- nerve injury of lumbosacral plexus
- coagulopathy with bleeding tendency
- not capable of speaking or understanding german or english
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Continuous Adductor Canal Block (CACB)
Continuous Adductor Canal block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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Actieve vergelijker: Continuous Femoral Nerve Block (CFNB)
Continuous Femoral Nerve Block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Timed-Up and Go-test for mobility evaluation
Tijdsspanne: third postoperative day
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The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
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third postoperative day
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain Scores
Tijdsspanne: 6, 24, 48, 72 hours postoperative
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Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain
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6, 24, 48, 72 hours postoperative
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Quadriceps strength
Tijdsspanne: 6, 24, 28, 72 hours postoperative
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Numeric Scale (0-5)
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6, 24, 28, 72 hours postoperative
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Ropivacaine consumption (each catheter)
Tijdsspanne: 24, 48, 72 hours postoperative
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Measurement of the total amount
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24, 48, 72 hours postoperative
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CAS (Cumulated Ambulation Score)
Tijdsspanne: 24,48,72 hours postoperative
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Cumulated Ambulation Score is calculated with routine data.
Measurement for ambulation ability
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24,48,72 hours postoperative
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Mobility Score (MoSc)
Tijdsspanne: 24,48,72 hours postoperative
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Is calculated with routine data.
Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)
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24,48,72 hours postoperative
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Analgesic regimen
Tijdsspanne: preop and 0, 6 , 24, 48, 48 hours postoperative
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Documentation of analgesic prescriptions and rescue medications during postoperative course
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preop and 0, 6 , 24, 48, 48 hours postoperative
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Karolin Piechowiak, Dr, Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
- Studie directeur: Thorsten Steinfeldt, Prof Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
- Studie directeur: Thomas Wiesmann, Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AZ 06/13
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