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

Phase 3

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Ropivacaine Intermittent Bolus; Drug: Ropivacaine Continuous Infusion; Drug: Placebo

• Registration Number: NCT05053087
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2022-04-13
• Primary Completion: 2023-02-27
• Study Completion: 2023-02-27
• Results First Submitted: 2024-01-13
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Results First Posted: 2024-02-22
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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%.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine intermittent bolus	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.
Ropivacaine continuous	Ropivacaine Continuous Infusion	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.
Single shot adductor canal	Placebo	Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Levels	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 Outcome Measures

Name	Time	Method
Amount of Medication Administered	60 days, or until discontinuation of narcotic medication (whichever is later)	Amount of medication administered via the patient-controlled function on the adductor catheter
Duration of Narcotic Used	60 days, or until discontinuation of narcotic medication (whichever is later)	Number of days that narcotic use was required.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States