Population Pharmacokinetics of Ropivacaine
1 other identifier
observational
28
0 countries
N/A
Brief Summary
The aim of this study was to investigate the pharmacokinetics of free and total ropivacaine after unilateral and bilateral TKA. A population model was successfully built and peak free ropivacaine concentration stayed below previously proposed toxic thresholds in patients undergoing unilateral as well as bilateral TKA receiving LIA with high dose ropivacaine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedJanuary 8, 2021
January 1, 2021
1.3 years
January 6, 2021
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Free and total plasma concentrations of ropivacaine
Free and total plasma concentrations of ropivacaine were measured within 24 hours using liquid chromatography - mass spectrometry
24 hours
Study Arms (2)
unilateral Total knee arthroplasty
Patients receiving unilateral Total knee arthroplasty
simultaneous bilateral Total knee arthroplasty
Patients receiving simultaneous bilateral Total knee arthroplasty y
Interventions
Free and total plasma concentrations of ropivacaine were measured within 24 hours using liquid chromatography - mass spectrometry. A population pharmacokinetic model was built using non-linear mixed effect models
Eligibility Criteria
Thirteen unilateral TKA and fifteen bilateral TKA patients were included in the study. All patients were operated in a well-described fast-track setup without use of drains or tourniquet. A standard midline skin incision with a medial para-patellar capsulotomy was used. All patients were operated with cemented CR components. In bilateral TKA cases, both knees were operated in one setting with the left knee always being operated first, and the second knee being operated sequentially in the same setting immediately following closure of the first knee.
You may qualify if:
- Patients undergoing unilateral TKA (n=13) and bilateral TKA (n=15) receiving LIA according to standard protocol.
You may not qualify if:
- Patients not receiving LIA Revision TKA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gromov K, Grassin-Delyle S, Foss NB, Pedersen LM, Nielsen CS, Lamy E, Troelsen A, Urien S, Husted H. Population pharmacokinetics of ropivacaine used for local infiltration anaesthesia during primary total unilateral and simultaneous bilateral knee arthroplasty. Br J Anaesth. 2021 Apr;126(4):872-880. doi: 10.1016/j.bja.2020.11.038. Epub 2021 Jan 15.
PMID: 33455802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 8, 2021
Study Start
January 1, 2017
Primary Completion
May 1, 2018
Study Completion
September 30, 2019
Last Updated
January 8, 2021
Record last verified: 2021-01