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Regional Anesthesia for Knee Replacement Surgery (TRUE KnORTH 2 Trial)
Phase 4
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* All adult patients presenting for a primary TKA.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial will look at how well patients recover after knee replacement surgery when they receive a joint injection and a nerve block with or without continuous infusion through a catheter."
Who is the study for?
This trial is for adults who are about to have their first knee replacement surgery. It's testing different pain management techniques after the operation. People can't join if they don't meet certain health requirements or conditions that the study outlines.
What is being tested?
The study is looking at how well patients recover from knee surgery using two pain relief methods: injections with a drug called Ropivacaine, and normal saline, which is like saltwater. Some will also get an extra numbing technique in the thigh area.
What are the potential side effects?
Ropivacaine may cause side effects such as low blood pressure, nausea, vomiting, dizziness, numbness around the injection site or allergic reactions. Normal saline typically has minimal side effects but might cause irritation at the infusion site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Brief Pain Inventory - Pain Interference scores
Complications
Frequency of opioid-related side effects (vomiting and nausea)
+8 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cACB activeExperimental Treatment1 Intervention
Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)
Group II: cACB shamPlacebo Group1 Intervention
Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,002 Total Patients Enrolled
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