No registrations found.
ID
Source
Brief title
Health condition
Total Knee Arthroplasty
Ropivacaine
tourniquet
Pharmacokinetic profile
Totale knieprothese
ropivacaine
bloedleegteband
farmacokinetisch profiel
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Mean total and unbound maximum serum concentration of ropivacaine (Cmax and Cumax)
- Mean time to total and unbound maximum serum concentration of ropivacaine (Tmax an Tumax)
Secondary outcome
not applicable
Background summary
Local infiltration analgesia (LIA) with ropivacaine for total knee arthroplasty (TKA) is increasingly used. Despite the high doses of ropivacaine, LIA is considered safe, and this perception is sustained by pharmacokinetic data demonstrating that maximum concentrations of ropivacaine stay well below the toxic threshold in plasma. These pharmacokinetic studies all involve TKA procedures with the use of a tourniquet. Recently, performing TKA without the use of a tourniquet is gaining popularity, but no pharmacokinetic data exist when LIA is administered for TKA without the use of a tourniquet. The purpose of this study was to describe the pharmacokinetic profile of a single-shot ropivacaine (200 mL 0.2%) and 0.75 mg epinephrine (1000 μg/mL) when used for LIA in patients for TKA without a tourniquet. In this prospective cohort study, 20 patients treated with LIA for TKA without a tourniquet are studied. Plasma samples are taken at 20, 40, 60, 90, 120, 240, 360, 480, 600, 720, and 1440 minutes after local anesthetic infiltration, in which total and unbound ropivacaine concentrations are determined.
Study objective
not applicable
Study design
baseline, 20, 40, 60, 90, 120, 240 ,360, 480, 600, 720 and 1440 minutes after ropivacaine infiltration
Intervention
bloodsamples 12 times 5-10 ml
Inclusion criteria
- age 50-80 years
- ASA physical health classification I ¨C II
- Body Mass Index (BMI) < 40
- Patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5%
- Scheduled for fast-track protocol TKA
- Hemoglobin (Hb) concentration ¡Ý 7.5 mMol/L
- Written informed consent
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 reason to perform surgery with the use of a tourniquet
- Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6159 |
| NTR-old | NTR6306 |
| CCMO | NL60548.048.17 |
| OMON | NL-OMON45473 |