Back to resultsA Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine Continuous Infusion
Ropivacaine Intermittent Bolus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility 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%.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Ropivacaine group with bolus infusions
Ropivacaine group with continuous infusions
Single shot adductor canal block group
Arm Description
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.
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.
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Outcomes
Primary Outcome Measures
Post-operative pain levels
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
Amount of medication administered
Amount of medication administered via the patient-controlled function on the adductor catheter
Duration of narcotic used
Number of days narcotic use is required
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05053087
Brief Title
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Official Title
A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Three-Arm, Double-Blinded, Randomized Controlled Trial
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine group with bolus infusions
Arm Type
Experimental
Arm Description
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.
Arm Title
Ropivacaine group with continuous infusions
Arm Type
Experimental
Arm Description
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.
Arm Title
Single shot adductor canal block group
Arm Type
Placebo Comparator
Arm Description
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Continuous Infusion
Intervention Description
0.2% continuous infusion 6mL/hr
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Intermittent Bolus
Intervention Description
0.2% intermittent bolus infusion 8mL every 2 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline filled catheter
Primary Outcome Measure Information:
Title
Post-operative pain levels
Description
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.
Time Frame
14 days post-operatively
Secondary Outcome Measure Information:
Title
Amount of medication administered
Description
Amount of medication administered via the patient-controlled function on the adductor catheter
Time Frame
60 days, or until discontinuation of narcotic medication (whichever is later)
Title
Duration of narcotic used
Description
Number of days narcotic use is required
Time Frame
60 days, or until discontinuation of narcotic medication (whichever is later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Wilke, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
We'll reach out to this number within 24 hrs