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
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Marburg, Tyskland, 35037
- University of Marburg Department of Anaesthesia And Intensive Care Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Timed-Up and Go-test for mobility evaluation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Scores
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Karolin Piechowiak, Dr, Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
- Studieleder: Thorsten Steinfeldt, Prof Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
- Studieleder: Thomas Wiesmann, Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AZ 06/13
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