Study to describe the processing of ropivacaine in the body when injected in the knee for pain treatment in total knee arthroplasty.

Pharmacokinetic profile of ropivacaine after periarticular local infiltration analgesia for primary total knee arthoplast without the use of a tourniquet.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24359

Enrollment

Registered

2017-01-16

Start date

2017-03-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty Ropivacaine tourniquet Pharmacokinetic profile Totale knieprothese ropivacaine bloedleegteband farmacokinetisch profiel

Interventions

bloodsamples 12 times 5-10 ml

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
-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)	—

Contacts

Public ContactMaaike Fenten

Sint Maartenskliniek

m.fenten@maartenskliniek.nl0243272941

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)