No registrations found.
ID
Source
Brief title
Health condition
All patients who will undergo TKA placement are potential subjects for this pilot study
Sponsors and support
Intervention
Outcome measures
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
Background summary
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
Study objective
•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
Study design
Pre, peri, post operative till discharge, 3 months and 1 year post operative
Intervention
Post operative LIA after TKA either with ropivacaine or the standard LIA procedure with ropivacaine and adrenaline mixture.
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4618 |
| NTR-old | NTR4769 |
| Other | 3.035 : 13-T-112 |
Summary results
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