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Phase 4 N=174 Randomized Single-blind Supportive Care

Block and Periarticular Injection Study

Pain, Postoperative

Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively — 3.41; 3.27 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
regional anesthesia and PAI (Drug); PAI (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
May 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively
3.41; 3.27
SECONDARY
Opioid Use
16.75; 12.82
SECONDARY
Daily Step Count at 2 Weeks Postop
3270.8; 3352.2
SECONDARY
Oxford Knee Score
25.2; 25.6
SECONDARY
Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep
26; 17
SECONDARY
Oxford Knee Score
25.2; 25.6
SECONDARY
Oxford Knee Score
25.2; 25.6
SECONDARY
Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep
36; 32
SECONDARY
Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep
41; 30

Summary

The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.

Eligibility Criteria

Inclusion Criteria

  • Planning to undergo Unilateral primary total knee arthroplasty.
  • 18 and up
  • Willing to sign informed consent
  • Willing to return for all follow-up visits
  • Smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria

  • BMI > 45
  • Preexisting functionally limiting neurologic disorders
  • Hepatic or renal insufficiency
  • History of unprovoked venous thromboembolism
  • Inability to complete baseline functional testing
  • Chronic opioid or gabapentin and pregabalin use (chronic defined as use >5 days per week prior to the surgical procedure)
  • Allergy or intolerance to trial medications
  • Planned admission to a postoperative rehabilitation facility
  • Planned general anesthesia
  • Receiving workers compensation or disability payments
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06410612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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