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Peri-Articular Injections, Adductor Canal Block, and IPACK for Knee Arthritis (IPACK Trial)
Phase 4
Waitlist Available
Led By David H Kim, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
Age 18 to 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours on post-operative day 1, 48 hours on post-operative day 2, and 72 hours on post-operative day 3
Awards & highlights
IPACK Trial Summary
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Eligible Conditions
- Knee Arthritis
IPACK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowIPACK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours on post-operative day 1, 48 hours on post-operative day 2, and 72 hours on post-operative day 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours on post-operative day 1, 48 hours on post-operative day 2, and 72 hours on post-operative day 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numeric Rating Scale (NRS) Pain Scores
Secondary outcome measures
Ambulation Distance During Physical Therapy
Hospital Length of Stay
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
+5 moreIPACK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Peri-Articular Injections, Adductor Canal Block, and IPACKExperimental Treatment7 Interventions
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
Injection prior to cementation
bupivacaine 0.25% with epinephrine 30cc;
methylprednisolone, 40 mg/ml, 1 ml
cefazolin, 500 mg in 10 ml
normal saline, 22cc
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine
Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Group II: Peri-Articular Injections onlyActive Control7 Interventions
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
Injection prior to cementation
bupivacaine 0.5% with epinephrine 30cc;
methylprednisolone, 40 mg/ml, 1 ml
cefazolin, 500 mg in 10 ml
normal saline, 22cc
Superficial injection prior to closure.
20cc 0.25% bupivacaine
2 mg IV dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine 20cc
2017
Completed Phase 4
~90
Bupivacaine with Dexamethasone
2017
Completed Phase 4
~90
Bupivacaine 25cc
2017
Completed Phase 4
~90
Bupivacaine with epinephrine
2017
Completed Phase 4
~110
Methylprednisolone
FDA approved
Cefazolin
FDA approved
8 MHz. Chiba needle
2017
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,816 Total Patients Enrolled
David H Kim, MDPrincipal InvestigatorHospital for Special Surgery, New York
5 Previous Clinical Trials
723 Total Patients Enrolled
Frequently Asked Questions
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