- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02873637
Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement (KTSS)
Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)
The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.
Patients will be randomized in two arms:
- catheter in position under sartorial (experimental group)
- femoral catheter (control group)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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La Roche sur Yon, Frankrig, 85925
- CHD Vendée de la Roche sur Yon
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Major Patient (≥ 18 years)
- Before tricompartmental benefit from knee replacement (TKR) unilateral,
- TKR programmed on one of the first three days of the week (Monday to Wednesday)
- Physical status score I-III,
- Non septic programmed surgery under general anesthesia
- Able to understand the protocol
- Written informed consent
- Social Insured
- Opportunity to be followed under the Protocol
Exclusion Criteria:
- Age ≥ 85 years
- Obesity (BMI ≥ 35)
- Revision TKR,
- Patients not cooperating or not including the French,
- Difficulties in understanding and evaluating the score pain (VAS),
- Preoperative cognitive dysfunction making unreliable interrogation
- Patient unable to read and / or write (literacy, ...)
- Known bleeding disorders,
- Vascular surgery for femoral vessels on the operated side,
- Neuropathy of the lower limb,
- Localized infection at the puncture catheters,
- Known allergy to ropivacaine,
- Renal and / or severe hepatic impairment,
- Taking opioids for more than a month before surgery,
- Intolerance to morphine,
- Rheumatic inflammatory disease,
- Patients receiving immunosuppressive therapy or long-term corticosteroid
- Allergy or against-indications to standard treatments administered intraoperative and postoperative
- Flexion deformity> 10 ° or valgus deformity with significant
- Refused to participate
- Patient trusteeship, guardianship, deprived of liberty
- Women premenopausal who become pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: under sartorial catheter
catheter under sartorial
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Andet: femoral catheter
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
International clinical score Daniels and Worthingham
Tidsramme: 2 day after surgery (total knee replacement)
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This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)
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2 day after surgery (total knee replacement)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CHD 065-16
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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