Osteoarthritis, KneePhase 3NCT05053087
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
A Phase 3 study testing Ropivacaine Continuous Infusion and Ropivacaine Intermittent Bolus in people with Osteoarthritis, Knee, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ropivacaine Continuous Infusion and Ropivacaine Intermittent Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2022to 27 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 90 years.
- Willing to participate in the study and competent to provide informed consent.
- Willing to comply with protocol procedures.
- Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.
Who cannot join
- The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery.
- The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway.
- Revision knee arthroplasty.
- Uncontrolled diabetes with A1C > 8.0%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ropivacaine Continuous Infusion, Ropivacaine Intermittent Bolus, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine Continuous InfusionDrug
0.2% continuous infusion 6mL/hr
Ropivacaine Intermittent BolusDrug
0.2% intermittent bolus infusion 8mL every 2 hours
PlaceboDrug
Saline filled catheter
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine intermittent bolus | Experimental | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus. Receives: Drug: Ropivacaine Intermittent Bolus |
| Ropivacaine continuous | Experimental | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion. Receives: Drug: Ropivacaine Continuous Infusion |
| Single shot adductor canal | Placebo comparator | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Levels
Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
Measured: 14 days post-operatively
Secondary outcomes (2)
Amount of Medication Administered
Amount of medication administered via the patient-controlled function on the adductor catheter
Measured: 60 days, or until discontinuation of narcotic medication (whichever is later)
Duration of Narcotic Used
Number of days that narcotic use was required.
Measured: 60 days, or until discontinuation of narcotic medication (whichever is later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start13 Apr 2022
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Three-Arm, Double-Blinded, Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin K. Wilke, Mayo Clinic
- Investigators
- Benjamin Wilke, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053087
- Sponsor's protocol ID
- 21-000974
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2021
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05053087
- Acronym / sponsor ID
- 21-000974
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A Three-Arm, Double-Blinded, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine intermittent bolus | Experimental | Drug: Ropivacaine Intermittent BolusSubjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus. |
| Ropivacaine continuous | Experimental | Drug: Ropivacaine Continuous InfusionSubjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion. |
| Single shot adductor canal | Placebo comparator | Drug: PlaceboSubjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 90 years.
- Willing to participate in the study and competent to provide informed consent.
- Willing to comply with protocol procedures.
- Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.
Key exclusion criteria (4 listed)
- The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery.
- The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway.
- Revision knee arthroplasty.
- Uncontrolled diabetes with A1C > 8.0%.
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 |
|---|---|---|
| Ropivacaine Continuous Infusion0.2% continuous infusion 6mL/hr | Drug | Ropivacaine continuous |
| Ropivacaine Intermittent Bolus0.2% intermittent bolus infusion 8mL every 2 hours | Drug | Ropivacaine intermittent bolus |
| PlaceboSaline filled catheter | Drug | Single shot adductor canal |
Primary outcome
Post-operative Pain Levels
Time frame: 14 days post-operatively
Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
2 secondary outcomes
Amount of Medication Administered
Time frame: 60 days, or until discontinuation of narcotic medication (whichever is later)
Duration of Narcotic Used
Time frame: 60 days, or until discontinuation of narcotic medication (whichever is later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Benjamin Wilke, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine Continuous Infusion and Ropivacaine Intermittent Bolus in people with Osteoarthritis, Knee, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 4 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Levels (time frame: 14 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2024.