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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053087
• Other study ID #: 21-000974
• Status: Completed
• Phase: Phase 3
• Start date: April 13, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%, compared to a single-shot adductor canal block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• Ropivacaine Continuous Infusion
0.2% continuous infusion 6mL/hr
• Ropivacaine Intermittent Bolus
0.2% intermittent bolus infusion 8mL every 2 hours
• Placebo
Saline filled catheter

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days post-operatively
Secondary	Amount of Medication Administered	Amount of medication administered via the patient-controlled function on the adductor catheter	60 days, or until discontinuation of narcotic medication (whichever is later)
Secondary	Duration of Narcotic Used	Number of days that narcotic use was required.	60 days, or until discontinuation of narcotic medication (whichever is later)

External Links

•   Mayo Clinic Clinical Trials