Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial (CLICA)
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.
In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.
Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Saint-etienne, Frankrig, 42055
- PASSOT
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Physical Status score = 1 or Physical Status score = 2
- Major Patient
- indication of anterior cruciate ligament reconstruction
- informed consent for participation in the study
Exclusion Criteria:
- Contraindication to general analgesia
- Contraindication to peripheral nerve block
- Allergy to analgesic treatment
- Porphyria,
- Neurologic deficit
- Contraindication antiinflammatory drugs
- Simultaneous reconstruction of another ligament or complex gesture intended
- Patient treated with an anti-arrhythmic drug class III
- Patient with severe hepatic impairment
- Pregnant woman
Studieplan
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 |
|---|---|
|
Aktiv komparator: femoral nerve block
20 ml injection of 2 mg/ml ropivacaine in femoral nerve
|
2 mg/ml
|
|
Eksperimentel: obturator nerve block and intraarticular injection
10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
number of patients with success
Tidsramme: 4 postoperative hours
|
success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5
|
4 postoperative hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain for all patients
Tidsramme: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
pain measured by EVA
|
Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
|
analgesic consumption for all patients
Tidsramme: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
analgesic consumption of tramadol and morphine (use, number)
|
Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
|
analgesic adverse events for all patients
Tidsramme: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
Frequency of nausea and vomiting
|
Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Sylvie PASSOT, MD, CHU de Saint-Étienne
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1408021
- 2014-002062-77 (EudraCT nummer)
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