patients receiving primary total knee replacement
Conditions
Interventions
Trade Name: Naropin
Product Name: Ropivacaine
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age 50-80 years - ASA physical health classification I – II - Body Mass Index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Placement of a surgical drain - Contra-indications for spinal anesthesia - Known hypersensitivity to amide-type local anesthetics - Hepatic or renal insufficiency - Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance. - Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A secondary objective of this study is to compare the pharmacokinetic profiles of total and unbound ropivacaïne and analyse its relationship. ;Primary end point(s): - Mean total and unbound maximum serum concentration of ropivacaine (Cmax) - Mean time to total and unbound maximum serum concentration of ropivacaine (Tmax) ;Timepoint(s) of evaluation of this end point: Before surgery, and at 20, 40, 60, 90, 120, 240, 360 minutes and 24 hours after release of the tourniquet.;Main Objective: The primary objective of this study is to describe a pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used in the LIA technique for the knee. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Age, weight, height, gender, co-medication, complications and signs of systemic toxicity will be recorded.;Timepoint(s) of evaluation of this end point: pre-operatively and post-operatively (t=24 hours) | — |
Countries
Netherlands
Contacts
Public Contactafdeling Research
Sint Maartenskliniek
Outcome results
None listed