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A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05053087
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Benjamin K. Wilke, Mayo Clinic

Study Description
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Brief 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%, compared to a single-shot adductor canal block.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Ropivacaine Continuous Infusion Drug: Ropivacaine Intermittent Bolus Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Three-Arm, Double-Blinded, Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Masking Description: This will be a double-blinded study. Computer randomization will be used for patient grouping and the research pharmacy will dispense the medication to the anesthesia team, who will set the adductor catheter dosing based upon randomization. The surgical team and patient will remain blinded to the medication and dosing regimen.
Primary Purpose: Treatment
Official Title: A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ropivacaine group with bolus infusions
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.
 Drug: Ropivacaine Intermittent Bolus
0.2% intermittent bolus infusion 8mL every 2 hours
Experimental: Ropivacaine group with continuous infusions
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.
 Drug: Ropivacaine Continuous Infusion
0.2% continuous infusion 6mL/hr
Placebo Comparator: Single shot adductor canal block group
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
 Drug: Placebo
Saline filled catheter


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative pain levels [ Time Frame: 14 days post-operatively ]
    Measured using a visual analogue scale (VAS) where subject places a mark on a horizontal line to rate the intensity of their pain at the time between no pain and worst pain imaginable.


Secondary Outcome Measures :
  1. Amount of medication administered [ Time Frame: 60 days, or until discontinuation of narcotic medication (whichever is later) ]
    Amount of medication administered via the patient-controlled function on the adductor catheter

  2. Duration of narcotic used [ Time Frame: 60 days, or until discontinuation of narcotic medication (whichever is later) ]
    Number of days narcotic use is required


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05053087


Contacts
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Contact: Angelica Klosowski 904-953-4529 Klosowski.Angelica@mayo.edu
Contact: Arjana Haliliovic (904) 953-8894 halilovic.arjana@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Benjamin Wilke, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Benjamin K. Wilke, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05053087    
Other Study ID Numbers: 21-000974
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents