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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
Must not have
Deemed unfit for continuous wound infusion due to allergies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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 belowSelect...
My health is good or fairly good.
Select...
I do not regularly take opioid painkillers before surgery.
Select...
I can bend my knee more than 90 degrees.
Select...
My liver functions normally.
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I am scheduled for a knee replacement at the Royal Alexandra Hospital.
Select...
I understand the study and agree to participate.
Select...
I am planning to have surgery that is not due to an injury.
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I am younger than 70 years old.
Select...
I will receive spinal anesthesia during surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to materials used in continuous wound infusions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can bend my knee more than 90 degrees.I am allergic to materials used in continuous wound infusions.I am scheduled for a knee replacement at the Royal Alexandra Hospital.I am considered fit for a specific pain management technique and not allergic to its medication.I understand the study and agree to participate.I am planning to have surgery that is not due to an injury.I am younger than 70 years old.My health is good or fairly good.I do not regularly take opioid painkillers before surgery.My liver functions normally.I will receive spinal anesthesia during surgery.
Research Study Groups:
This trial has the following groups:- Group 1: S
- Group 2: C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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