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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2023-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty

NCT02798835

Total Knee Arthroplasty

COMPLETED PHASE4

Adductor Canal Catheter Effectiveness and Safety Study

NCT04639128

Total Knee Replacement Surgery

COMPLETED NA

Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty

NCT02603900

Acute Pain Regional Anesthesia Morbidity

WITHDRAWN PHASE4

Comparison of Two Multimodal Analgesia Regimens in Total Knee Arthroplasty

NCT03990038

Postoperative Pain

TERMINATED NA

Pre vs Post Block in Total Knee Arthroplasty (TKA)

NCT05974501

Knee Osteoarthritis Arthroplasty Complications Postoperative Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Three-Arm, Double-Blinded, Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ropivacaine Intermittent Bolus

Intervention Type DRUG

0.2% intermittent bolus infusion 8mL every 2 hours

Ropivacaine continuous

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.

Group Type EXPERIMENTAL

Ropivacaine Continuous Infusion

Intervention Type DRUG

0.2% continuous infusion 6mL/hr

Single shot adductor canal

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline filled catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine Continuous Infusion

0.2% continuous infusion 6mL/hr

Intervention Type DRUG

Ropivacaine Intermittent Bolus

0.2% intermittent bolus infusion 8mL every 2 hours

Intervention Type DRUG

Placebo

Saline filled catheter

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No