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Active Treatment for Acute Pain

Phase 4
Waitlist Available
Led By Engy Said, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day (pod) 0-1, as defined by 24 hours after ipack block placement
Awards & highlights

Study Summary

Comparing the pain control outcomes for patients undergoing total knee arthroplasty (TKA) with either: 1) adductor canal single shot injection plus placebo iPACK injection or 2) adductor canal single shot injection plus bupivacaine and dexamethasone iPACK injection. There are two surgical approaches for TKA 1) open 2) ROSA robotic assisted. Both follow the same pain management pathway. We plan to enroll patient undergoing either surgical procedure.

Eligible Conditions
  • Acute Pain
  • Osteoarthritis
  • Local Anesthesia
  • Regional Anesthesia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day (pod) 0-1, as defined by 24 hours after ipack block placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day (pod) 0-1, as defined by 24 hours after ipack block placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Opioid Use POD 0-1
Average Pain Score at Rest
Average Pain Score with Motion
Secondary outcome measures
Average Opioid Use postoperative day (POD) 1-2
Average Pain Score, postoperative day (POD) 1-2.
Gait Distance
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active TreatmentActive Control1 Intervention
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus distal iPACK (between femoral condyles) single shot with long acting local anesthetic (ropivacaine) plus dexamethasone
Group II: PlaceboPlacebo Group1 Intervention
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,393 Total Patients Enrolled
11 Trials studying Acute Pain
1,061 Patients Enrolled for Acute Pain
Engy Said, MDPrincipal InvestigatorUniversity of California, San Diego

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
iPACK Block With Dexamethasone For Total Knee Replacement
Engy T. Said, MD 2021. "iPACK Block With Dexamethasone For Total Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04917055.
~4 spots leftby Apr 2025
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