- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Marburg, Tyskland, 35037
- University of Marburg Department of Anaesthesia And Intensive Care Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
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)
|
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Timed-Up and Go-test for mobility evaluation
Tidsram: third postoperative day
|
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
|
third postoperative day
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Scores
Tidsram: 6, 24, 48, 72 hours postoperative
|
Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain
|
6, 24, 48, 72 hours postoperative
|
|
Quadriceps strength
Tidsram: 6, 24, 28, 72 hours postoperative
|
Numeric Scale (0-5)
|
6, 24, 28, 72 hours postoperative
|
|
Ropivacaine consumption (each catheter)
Tidsram: 24, 48, 72 hours postoperative
|
Measurement of the total amount
|
24, 48, 72 hours postoperative
|
|
CAS (Cumulated Ambulation Score)
Tidsram: 24,48,72 hours postoperative
|
Cumulated Ambulation Score is calculated with routine data.
Measurement for ambulation ability
|
24,48,72 hours postoperative
|
|
Mobility Score (MoSc)
Tidsram: 24,48,72 hours postoperative
|
Is calculated with routine data.
Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)
|
24,48,72 hours postoperative
|
|
Analgesic regimen
Tidsram: preop and 0, 6 , 24, 48, 48 hours postoperative
|
Documentation of analgesic prescriptions and rescue medications during postoperative course
|
preop and 0, 6 , 24, 48, 48 hours postoperative
|
Samarbetspartners och utredare
Utredare
- Studierektor: Karolin Piechowiak, Dr, Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
- Studierektor: Thorsten Steinfeldt, Prof Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
- Studierektor: Thomas Wiesmann, Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AZ 06/13
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