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

February 20, 2024 updated by: Benjamin K. Wilke, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine intermittent bolus
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 continuous
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
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Drug: Placebo
Saline filled catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Number of days that narcotic use was required.
60 days, or until discontinuation of narcotic medication (whichever is later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Benjamin Wilke, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000974

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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