Phase 3 N=60 Randomized Double-blind Treatment

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

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT05053087 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Post-operative Pain Levels — 5.1; 5.1; 6.1 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ropivacaine Continuous Infusion (Drug); Ropivacaine Intermittent Bolus (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-operative Pain Levels	5.1; 5.1; 6.1	—
SECONDARY Amount of Medication Administered	138; 111; 144	—
SECONDARY Duration of Narcotic Used	21; 14; 14	—

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.

Eligibility Criteria

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%.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05053087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.