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PAI + ACB & IPACK for Total Knee Replacement

Phase 4
Waitlist Available
Led By Jacques YaDeau, MD, PhD
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
Planned use of regional anesthesia
English speaking (Secondary outcomes include questionnaires validated in English only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
Awards & highlights

Study Summary

Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. 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 scores (NRS, 0-10) with ambulation on POD1
Secondary outcome measures
Blinding assessment; Bang question (POD1)
DN4 Neuropathic Assesment (PreOp, 3months)
NRS pain score at rest (POD0,POD1, POD2, 3 months)
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PAI + ACB & IPACKActive Control1 Intervention
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Group II: No PAI + ACB & IPACKPlacebo Group1 Intervention
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,270 Total Patients Enrolled
Jacques YaDeau, MD, PhDPrincipal InvestigatorHospital for Special Surgery, New York
3 Previous Clinical Trials
296 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?
2020. "Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04749615.
~22 spots leftby Apr 2025
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