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

NCT05053087 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 21-000974
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Amount of Medication Administered

  60 days, or until discontinuation of narcotic medication (whichever is later)

• Duration of Narcotic Used

  60 days, or until discontinuation of narcotic medication (whichever is later)

Study Arms (3)

Ropivacaine intermittent bolus

EXPERIMENTAL

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

Ropivacaine continuous

EXPERIMENTAL

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

Single shot adductor canal

PLACEBO COMPARATOR

Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.

Drug: Placebo

Interventions

Ropivacaine Continuous Infusion DRUG

0.2% continuous infusion 6mL/hr

Ropivacaine continuous

Ropivacaine Intermittent Bolus DRUG

0.2% intermittent bolus infusion 8mL every 2 hours

Ropivacaine intermittent bolus

Placebo DRUG

Saline filled catheter

Single shot adductor canal

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Benjamin K. Wilke, M.D.
• Organization: Mayo Clinic

Wilke.Benjamin@mayo.edu

904-953-2405

Study Officials

• Benjamin Wilke, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Three-Arm, Double-Blinded, Randomized Controlled Trial

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: April 13, 2022
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2024-02

Locations

US (1)