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 Arthroplasty Without the use of a Tourniquet. - LIAkin II

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000180-32-NL

Enrollment

Registered

2017-01-25

Start date

2017-02-10

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

patients receiving primary total knee replacement

Interventions

Trade Name: Naropin Product Name: Ropivacaine Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 50-80 years - ASA physical health classification I – II - Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 20

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
Main Objective: The primary objective of this study is to describe a pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet. ;Secondary Objective: Not applicable; Primary end point(s): - 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) ;Timepoint(s) of evaluation of this end point: baseline and 20, 40, 60, 90 , 120, 240, 360, 480, 600, 720 and 1440 minutes after ropivacain infiltration	—

Measure

Time frame

Main Objective: The primary objective of this study is to describe a pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet. ;Secondary Objective: Not applicable; Primary end point(s): - 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) ;Timepoint(s) of evaluation of this end point: baseline and 20, 40, 60, 90 , 120, 240, 360, 480, 600, 720 and 1440 minutes after ropivacain infiltration

—

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: baseline and/or post study	—

Countries

Netherlands

Contacts

Public Contactafdeling research

Sint Maartenskliniek Nijmegen

secretariaat.rde@maartenskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026