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van CCT (UK)


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van CCT (UK)


Local infiltration analgesia with or without adrenaline in TKA


- candidate number19394
- NTR NumberNTR4769
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2014
- Secondary IDs13-T-112 3.035
- Public TitleLocal infiltration analgesia with or without adrenaline in TKA
- Scientific TitleAdrenaline use in local infiltration analgesia during TKA: randomized, double blind, controlled pilot study
- ACRONYMLIA, TKA, UKA, adrenaline
- hypothesis•LIA with ropivacaine will result in comparable clinical results in terms of post operative pain as LIA procedure with mixture of ropivacaine and adrenaline
•LIA with ropivacaine will result in comparable reduction of post operative analgesia use as LIA procedure with mixture of ropivacaine and adrenaline
•LIA with ropivacaine will result comparable early mobilisation and hospital discharge as LIA procedure with mixture of ropivacaine and adrenaline
•LIA with ropivacaine will result in comparable complications/adverse events as LIA procedure with mixture of ropivacaine and adrenaline
- Healt Condition(s) or Problem(s) studiedAnalgesia, Total knee arthroplasty
- Inclusion criteria•Painful and disabled knee joint resulting from osteoarthritis
•High need to obtain pain relief and improve function
•Able and willing to follow instructions
•Consent form read, understood and signed by patient.
- Exclusion criteria•Active infection in knee
•General infection
•Distant foci of infections which may spread to the implant site
•Failure of previous joint replacement
•Pregnancy
•Contraindication for ropivacaine
•Contraindication for adrenaline
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-mei-2014
- planned closingdate1-feb-2015
- Target number of participants20
- InterventionsPost operative LIA after TKA either with ropivacaine or the standard LIA procedure with ropivacaine and adrenaline mixture.
- Primary outcome• VAS pain score direct post operative and 16:00H and 22:00H on the operative day.
• VAS pain score before and after the first mobilisation.
• VAS pain score at 8:00H, 16:00H and 22:00H till day of discharge
- Secondary outcome• Amount of post operative analgesia use direct post operative till day of discharge
• Time to first mobilisation
• Length of hospital stay
• Adverse events/complications: Intra-operative, post-operative during pilot study
- TimepointsPre, peri, post operative till discharge, 3 months and 1 year post operative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNo advantage of adrenaline in the local infiltration analgesia mixture during total knee arthroplasty. Schotanus MG, Bemelmans YF, van der Kuy PH, Jansen J, Kort NP. Knee Surg Sports Traumatol Arthrosc. 2015 Jul 26. [Epub ahead of print] PMID: 262109
- Brief summaryThe aims of this pilot study are: to investigate whether LIA with ropivacaine is at least as effective in short term outcome as the widely used current method, LIA procedure with mixture of ropivacaine and adrenaline
- Main changes (audit trail)
- RECORD4-sep-2014 - 29-jul-2015


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