The primary objective is to assess the pharmacokinetics of ropivacaine after LIA in the local infiltration technique for patients with TKA.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The determination of pharmacokinetic parameters of ropivacaine after LIA in
patients with TKA.
Secondary outcome
Not applicable.
Background summary
The local infiltration anesthesia technique in patients with total knee
arthroplasty is a standard used treatment in the Reinier de Graaf Groep
hospital. Much is known, including the efficacy, but the pharmacokinetics are
not yet been fully clarified. Therefore, in this study the pharmacokinetics are
determined, with the aim of future research on dose finding.
Study objective
The primary objective is to assess the pharmacokinetics of ropivacaine after
LIA in the local infiltration technique for patients with TKA.
Study design
Prospective cohort study
Study burden and risks
This study brings neither extra risks nor benefits directly for the patients.
The patients receive the same care, as usual in TKA care using this kind of
anesthesia techniques. The additional load is catherisation and 9 extra blood
samples of 2-3 mL for the determination of PK data collected with an indwelling
venous catheter (Venflon) in addition to routine blood sampling in the TKA
procedure.
Simultaneously with the blood sampling, patients, nurses and ward doctors will
be asked to report and document the intensity and frequency of PONV on a
questionnaire (standard policy). Additional on the questionnaire, the pain
intensity will be asked, with the use of an eleven point Visual Analogue Scale
(0-10, 0 = no pain; 10 = unbearable pain). The time of each survey will be
logged precisely.
Reinier de Graafweg 7
2526 AD Delft
NL
Reinier de Graafweg 7
2526 AD Delft
NL
Listed location countries
Age
Inclusion criteria
- Totaal knee arthroplasty surgery
- Age older than 18 years
- Willing to participate in the study after consultation and written informed consent after Pre-Operative Screening (POS)
Exclusion criteria
- Known allergy to amide type local anaesthetics or for any other drugs used routinely during this type of surgery
- Mentally retarded
- Taking opiates or antiemetics (other than used in the protocol and used prior to the POS)
- Taking CYP1A2 inhibitors
- Taking CYP3A4 inhibitors
- Liver failure (ALAT, ASAT, gamma-GT and bilirubin > 3 times upper reference value)- Renal failure (GFR <30 ml/min)
- Known alcohol (drink more than 5 alcohol units in any one day), drug or medication abuse. (noted during the POS)
- Renal failure (GFR <30 ml/min, determined with measuring the serum creatin and using the Cockroft-Gault formula)
- Severe obesity (BMI *40)
Design
Recruitment
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL38840.098.11 |