Knee OsteoarthritisNCT04702282
Population Pharmacokinetics of Ropivacaine
An observational study of Knee Osteoarthritis, run by Hvidovre University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ropivacain concentration measurements
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients undergoing unilateral TKA (n=13) and bilateral TKA (n=15) receiving LIA according to standard protocol.
Who cannot join
- Patients not receiving LIA Revision TKA
About this study
Official title: Population Pharmacokinetics of Ropivacaine Used for Local Infiltration Anesthesia During Primary Total Unilateral and Simultaneous Bilateral Knee Arthroplasty
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.
Read the detailed description
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.21 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. Patients undergoing unilateral TKA received spinal anesthesia with 2 mL 0.5% hyperbaric bupivacaine, whereas patients scheduled for bilateral TKA received spinal anaesthesia with 3 mL 0.5% hyperbaric bupivacaine. Local infiltration anesthesia was performed as previously described with 200 mL 0.2% ropivacaine (400 mg) mixed with 1 mL 1 mg/mL epinephrine injected periarticularly in each knee. The first 50 mL were injected into the posterior capsule, 100 mL were injected into medial, anterior and lateral structures of the knee and capsule and the final 50 mL were injected in the subcutaneous tissue. All patients were mobilized on the day of surgery and thromboembolic prophylaxis started 6-8 hours postoperatively with rivaroxaban tablets (10 mg) given once daily until discharge. No extended thromboembolic prophylaxis was given to any patient. All patient received 1 g intravenous tranexamic acid preoperatively and 1 g 3 hours postoperatively.
Preoperative blood samples were taken within a week of surgery including electrolytes, hemoglobin and serum creatinine levels. Baseline blood sample was taken just before incision of the first knee, and additional blood samples were drawn at 1, 5, 30 and 60 minutes as well as 2, 4, 8 and 24 hours after incision following unilateral TKA and at 1, 5, 30 minutes after the incision of the first knee and 0, 5 and 15 minutes after incision of the second knee as well as after 1,2, 4 8 and 24 hours (total 9 and 12 timepoints within 24 hours for unilateral and bilateral TKA, respectively). Patient demographics were recorded and included age, gender, height and weight.
Ropivacaine measurement Ropivacaine concentrations were determined in plasma samples using liquid-chromatography coupled to mass spectrometry following a fully validated method
- Conditions
- Knee Osteoarthritis
- Being tested
- ropivacain concentration measurements
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacain concentration measurementsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| unilateral Total knee arthroplasty | Patients receiving unilateral Total knee arthroplasty Receives: Diagnostic Test: ropivacain concentration measurements | |
| simultaneous bilateral Total knee arthroplasty | Patients receiving simultaneous bilateral Total knee arthroplasty y Receives: Diagnostic Test: ropivacain concentration measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free and total plasma concentrations of ropivacaine
Free and total plasma concentrations of ropivacaine were measured within 24 hours using liquid chromatography - mass spectrometry
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2017
- Primary completion1 May 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Gromov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702282
- Sponsor's protocol ID
- H-16027950
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33455802
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Ropivacaine Used for Local Infiltration Anesthesia During Primary Total Unilateral and Simultaneous Bilateral Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04702282
- Acronym / sponsor ID
- H-16027950
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.21 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. Patients undergoing unilateral TKA received spinal anesthesia with 2 mL 0.5% hyperbaric bupivacaine, whereas patients scheduled for bilateral TKA received spinal anaesthesia with 3 mL 0.5% hyperbaric bupivacaine. Local infiltration anesthesia was performed as previously described with 200 mL 0.2% ropivacaine (400 mg) mixed with 1 mL 1 mg/mL epinephrine injected periarticularly in each knee. The first 50 mL were injected into the posterior capsule, 100 mL were injected into medial, anterior and lateral structures of the knee and capsule and the final 50 mL were injected in the subcutaneous tissue. All patients were mobilized on the day of surgery and thromboembolic prophylaxis started 6-8 hours postoperatively with rivaroxaban tablets (10 mg) given once daily until discharge. No extended thromboembolic prophylaxis was given to any patient. All patient received 1 g intravenous tranexamic acid preoperatively and 1 g 3 hours postoperatively.
Preoperative blood samples were taken within a week of surgery including electrolytes, hemoglobin and serum creatinine levels. Baseline blood sample was taken just before incision of the first knee, and additional blood samples were drawn at 1, 5, 30 and 60 minutes as well as 2, 4, 8 and 24 hours after incision following unilateral TKA and at 1, 5, 30 minutes after the incision of the first knee and 0, 5 and 15 minutes after incision of the second knee as well as after 1,2, 4 8 and 24 hours (total 9 and 12 timepoints within 24 hours for unilateral and bilateral TKA, respectively). Patient demographics were recorded and included age, gender, height and weight.
Ropivacaine measurement Ropivacaine concentrations were determined in plasma samples using liquid-chromatography coupled to mass spectrometry following a fully validated method
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral Total knee arthroplasty | – | Diagnostic Test: ropivacain concentration measurementsPatients receiving unilateral Total knee arthroplasty |
| simultaneous bilateral Total knee arthroplasty | – | Diagnostic Test: ropivacain concentration measurementsPatients receiving simultaneous bilateral Total knee arthroplasty y |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing unilateral TKA (n=13) and bilateral TKA (n=15) receiving LIA according to standard protocol.
Key exclusion criteria (1 listed)
- Patients not receiving LIA Revision TKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacain concentration measurementsFree 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 | Diagnostic test | simultaneous bilateral Total knee arthroplasty, unilateral Total knee arthroplasty |
Primary outcome
Free and total plasma concentrations of ropivacaine
Time frame: 24 hours
Free and total plasma concentrations of ropivacaine were measured within 24 hours using liquid chromatography - mass spectrometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 33455802Gromov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Hvidovre University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free and total plasma concentrations of ropivacaine (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04702282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.