Phase 4
N=174
Block and Periarticular Injection Study
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT06410612 ↗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
| Outcome | Result | p-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
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.