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Continuous Wound Infusion for Total Knee Replacement

N/A

Waitlist Available

Led By Gordon Arnett, MD

Research Sponsored by Capital Health, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA risk classification of 1 or 2

Do not regularly use opioid medication pre-operatively

Timeline

Screening 3 weeks

Treatment Varies

Follow Up discharge from hospital

Awards & highlights

Study Summary

This trial will compare pain and other patient outcomes after total knee replacement when using a continuous wound analgesia system, versus usual methods of pain control.

Who is the study for?

This trial is for adults under 70 in Edmonton needing a knee replacement, who can understand English and have someone to care for them at home. They should be healthy enough for surgery with no allergies to Bupivacaine, not use opioids regularly, have a BMI under 40, and must provide consent.Check my eligibility

What is being tested?

The study compares the effectiveness of continuous wound infusion pain relief using On-Q PainBuster with Bupivacaine against usual pain control methods after knee replacement surgery. It also assesses if this method eases nursing care.See study design

What are the potential side effects?

Possible side effects may include reactions to Bupivacaine such as numbness around the wound area, weakness, nausea or vomiting. There might also be risks associated with the device like infection or discomfort at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is good or fairly good.

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I do not regularly take opioid painkillers before surgery.

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I can bend my knee more than 90 degrees.

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My liver functions normally.

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I am scheduled for a knee replacement at the Royal Alexandra Hospital.

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I understand the study and agree to participate.

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I am planning to have surgery that is not due to an injury.

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I am younger than 70 years old.

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I will receive spinal anesthesia during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operatively for three days then again at follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operatively for three days then again at follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operatively for three days then again at follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain, measured by the 11-point numerical pain rating scale

Secondary outcome measures

Length of Stay

Narcotic medications taken

Number of adverse events

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SExperimental Treatment1 Intervention

Patients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively.

Group II: CActive Control1 Intervention

Usual care - post operative pain medications as per the knee arthroplasty care map.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Capital Health, CanadaLead Sponsor

15 Previous Clinical Trials

20,035 Total Patients Enrolled

Gordon Arnett, MDPrincipal InvestigatorCapital Health, Canada

Media Library

On-Q PainBuster with Bupivacaine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00724074 — N/A

Total Knee Replacement Research Study Groups: S, C

Total Knee Replacement Clinical Trial 2023: On-Q PainBuster with Bupivacaine Highlights & Side Effects. Trial Name: NCT00724074 — N/A

On-Q PainBuster with Bupivacaine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00724074 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications for individuals to be accepted into this experiment?

"To be eligible to partake in this clinical trial, individuals must have undergone a total knee arthroplasty (tka) and fall within an age bracket of 18 to 69. The research project is looking for 20 participants in total."

Answered by AI