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

Pharmacokinetic profile of ropivacaine after periarticular local infiltration analgesia for primary knee arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21012

Enrollment

Registered

2014-08-07

Start date

2014-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

patients requiring unilateral total knee replacement

Interventions

Patients will receive a total knee replacement under spinal anesthesia and Local Infiltration Analgesia (LIA) of the knee with 200 mL ropivacaine 0.2% and epinephrine.

Eligibility

Inclusion criteria

Inclusion criteria: - age 50-80 years - ASA physical Health Classification I-II - Body Mass Index (BMI) 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 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 mean time to total and unbound maximum serum concentration of ropivacaine (Tmax)	—

Secondary

Measure	Time frame
Age, weight, height, gender, co-medication, complications and signs of systemic toxicity will be recorded.	—

Contacts

Public ContactMaaike Fenten

Sint Maartenskliniek

m.fenten@maartenskliniek.nl0243272941

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)