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Completed

NCT Number: NCT05053087

A Study to Compare the Effectiveness 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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Ropivacaine Continuous Infusion

Drug

0.2% continuous infusion 6mL/hr

Ropivacaine Intermittent Bolus

Drug

0.2% intermittent bolus infusion 8mL every 2 hours

Placebo

Drug

Saline filled catheter

Primary outcomes

  1. 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.

Secondary outcomes

  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 that narcotic use was required.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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