•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…
ID
Bron
Verkorte titel
Aandoening
All patients who will undergo TKA placement are potential subjects for this pilot study
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• VAS pain score direct post operative and 16:00H and 22:00H on the operative day.<br>
• VAS pain score before and after the first mobilisation.<br>
• VAS pain score at 8:00H, 16:00H and 22:00H till day of discharge
Achtergrond van het onderzoek
The 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
Doel van het onderzoek
•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
Onderzoeksopzet
Pre, peri, post operative till discharge, 3 months and 1 year post operative
Onderzoeksproduct en/of interventie
Post operative LIA after TKA either with ropivacaine or the standard LIA procedure with ropivacaine and adrenaline mixture.
Publiek
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Wetenschappelijk
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4618 |
| NTR-old | NTR4769 |
| Ander register | 3.035 : 13-T-112 |
Samenvatting resultaten
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